GUIDELINES FOR RISK MANAGEMENT IN MEDICAL ELECTRICAL EQUIPMENT See Appendix A 1.

Scope The scope of these guidelines is to give an uniform approach on how to assess compliance with the relevant clauses of IEC 60601-1:2005 related to ISO 14971:2000. 2. Reference documents IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 14971:2000, Medical devices – Application of risk management to medical devices IECEE - CB Scheme - TRF60601-1_d 3. Terms and definitions For the purposes of this Guide, the terms and definitions of ISO 14971:2000 and IEC 606011:2005 apply. For the purpose of this document the Risk Management System is a management system intended to address all activities related to ISO14971. 4. Application of Risk Management Principle for IEC 60601-1:2005 CB Scheme investigations 4.1 General The third edition of IEC 60601-1 is the primary standard in a series of standards that covers safety and essential performance of medical electrical equipment. It is the first IEC standard in the scope of the CB Scheme that incorporates risk management principles according to ISO 14971. The introduction of Risk Management is the reason for this guide. The existence of a CB Test Certificate does not establish solely legal market entry. However, it could be used to help substantiate a request for legal market access. This guideline is related solely to the IECEE CB Scheme and is intended for use by those individuals with a working knowledge of risk management for medical electrical equipment and the provisions of the IEC 60601-1:2005. 5. Guidance on how to address Risk Management principles in the IEC 60601-1 CB Scheme investigations 5.1 General principles There is a general requirement to perform the risk management process as specified in ISO 14971 (IEC 60601-1, Clause 4.2.) The registration to ISO 13485 is not sufficient to demonstrate that a risk management process compliant with ISO 14971 requirements is performed. There can be no investigation to IEC 60601-1 third edition without the manufacturer’s Risk Management File being available. 1/3

In the clauses of IEC 60601-1 there are three types of references to ISO 14971 Risk Management requirements: 1. Direct reference to Risk Management Process as specified by ISO 14971 (for example clause 4.2). 2. Test related references to give appropriate alternative to the application of laboratory testing with specific pass/fail criteria or to select appropriate tests to be performed on the specific product (for example clause 5.7). 3. Indirect reference to offer additional elements to be considered in the implementation of the Risk Management Process specified by ISO 14971 for the specific product. (for example clause 14.1) The CB Test Report and Certificate confirms that there is a Risk Management Process performed which complies with ISO 14971. This does not mean that a complete Risk Management System in compliance with ISO 14971 is in place However, the CB Test Report is only a snapshot in time and does not necessarily assess top management responsibilities, such as, but not limited to, provision of adequate resources and assignment of qualified personnel. In view of the above and similar to the second edition, the CB report according to IEC606011:2005 is not necessarily a guarantee of certification by an accepting NCB. A separate certification of registration to ISO 14971 means that a risk management system fully conforming to ISO 14971 is in place, but does not provide the risk management device specific documentation necessary to meet the requirements of IEC 60601-1. IEC 60601-1 requires specific Risk Management activities to be done and the CB test report requires objective evidence that these activities have been performed for the device in question. A CB Scheme Certificate does not imply that an audit of the manufacturer’s Risk Management System was conducted. A certificate of registration may be requested for local or regional certification to IEC 60601-1 as it relates to follow-up services. There may be differences in requirements that are the subject of local legal market entry requirements. To assess the requirements for Risk Management process required by IEC 60601-1, the CB Scheme utilizes an addendum embedded within the IEC60601-1 TRF containing reference to the manufacturer's documents intended to support objective evidence of compliance. The table in Appendix A provides mapping with all the Risk Management clauses of IEC606011:2005 and the clauses in ISO 14971 that are referenced in the TRF Addendum. In filling in the TRF addendum, the user of the map should consider applicability of clauses to the Device Under Test. 5.2 Workflow 1. Based on the TRF, establish the relevant clauses of IEC60601-1 that have to be supported by RM documentation 2. Verify the required documentation and identify the relevant reference points to be listed in the TRF 3. In case the use of RM influences the tests 3.1. Identify the test to be conducted 3.2. Identify the test parameters and conditions to be used performing the tests 2/3

3.3. Verify the pass/fail criteria. The pass/fail criteria and the rationale for acceptance shall be reported in the TRF. 3.4. Perform the test and report the result in the TRF

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2 ACCESSIBLE PARTS 5.5 Risk Management Plan 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.9. type of current.2 4.1 APPLIED PARTS 5.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4. atmospheric pressure 5.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.9.4 Qualification of Personnel 3.2 Risk Management Process 3.7 Humidity preconditioning treatment 5.10.6 PATIENT 4.3 Management Responsibilities 3.6 Repairs and modifications 5.1 Test finger 5.1 5.9.3 Ambient temperature.4 Other conditions Supply voltages. nature of supply.APPENDIX A Clause 60601-1:2005 Topic 3.2 ME SYSTEMS 4.3 ESSENTIAL PERFORMANCE 4.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples 5.4 EXPECTED SERVICE LIFE 4.3 Actuating mechanisms 1/120 .10.2.2 Test hook 5.1 Source of power for ME EQUIPMENT 4.9.9 PARTS 5.2.11 5 5.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4. 5.5 frequency 5.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.9.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.2.10' Power supply 4.9 CHARACTERISTICS in ME EQUIPMENT 4. humidity.

6 7 7.2.2.1 7.2.2.2.14 7. marking and documents General USABILITY of the identification.2 Risk Management Process 3.1.2 7.2 Protection against electric shock Protection against harmful ingress of water or 6.2 Identification 7.8.2.2.2.2 7.5 7.1.11 7.2.3 Consult ACCOMPANYING DOCUMENTS 7.7 7.2.6 7.2.1 General 6.10 7.1 7.2. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.15 7.3 7.1.5 6.5 Risk Management Plan 6 Classification 6.2.8.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable 7.16 2/120 .2.2 7.4 Method(s) of sterilization 6.12 7.4 6.2.2.13 7.3 particulate matter 6.2.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability 7.8 7.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification.2.3 Management Responsibilities 3.1 7.APPENDIX A Clause 60601-1:2005 Topic 3.9 7.4 Qualification of Personnel 3.

3 7.6.2 Risk Management Process 3.4.6.4 Qualification of Personnel 3.1 7.5 7.3 EQUIPMENT parts (see also Table C.7.4.4 C.18 7.4 7.2 7.3 Units of measure 7.6 7.3.1 Heating elements or lampholders 7.3.4.19 7.3.APPENDIX A Clause 60601-1:2005 Topic 3.7.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.3.5 7.3.2.2.7.7.2.2.3) 7.5 PROTECTIVE EARTH TERMINALS 7.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.8 7.6 FUNCTIONAL EARTH TERMINALS 7.7 7.17 7.3 7.3 Management Responsibilities 3.5 Risk Management Plan 7.1 Power switches 7.7 Supply terminals 7.2 7.3.6.2 HIGH VOLTAGE parts 7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights 3/120 .4 RELEASES 7.2 Control devices 7.7.3 Batteries Fuses. THERMAL CUT-OUTS and OVER-CURRENT 7.1 7.8.3.3.2) 7.

1 Fundamental rule of protection against electric shock 8.APPENDIX A Clause 60601-1:2005 Topic 3.1 7.4) Instructions for use (see also Table C.9.2.9.2 Colours of controls 7.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.1 7.9.5 Risk Management Plan 7.8 7.2 Risk Management Process 3.2.2.2.2 7.9.1 Environmental protection Reference to the technical description Technical description (see also Table C.9.2.3.9.3 7.2.9. 7.2. component part lists.9.9.2.9.4 Qualification of Personnel 3.4 Electrical power source ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.12 7.9.2.9.2.6) General Replacement of fuses.6 7.3.9.15 7.9.3. POWER SUPPLY CORDS and 7. disinfection and sterilization Maintenance ACCESSORIES.2 Requirements related to power sources 8.9.14 material 7.2.3 Circuit diagrams.10 7.16 7.5 7.2.11 7.9.2.3 Management Responsibilities 3.3.9.9. supplementary equipment.2.2 7.9 ACCOMPANYING DOCUMENTS General (see also Table C.3 power supply 7.2.9. used 7.9.8.13 7.9 7.7 7.9.1 Connection to a separate power source 4/120 . etc.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.9.2 other parts 7.9.2.2.

2 Risk Management Process 3.1.4 Qualification of Personnel 3.5.4.5.5.1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS 8.1.2.2 Connection to an external d.3 Classification of APPLIED PARTS 8.5.1 8.2 TYPE B APPLIED PARTS 8.5.4.1.2.5 Risk Management Plan 8.5.2 Energy reduction test 5/120 .1 MEANS OF PROTECTION (MOP) 8.2 8.2.c. current or energy 8.5.5.5.3 MAXIMUM MAINS VOLTAGE 8.5.2 8.4 Limitation of voltage.5.4.4 Internal capacitive circuits 8.3 8.3 source by a plug 8.1 Defibrillation protection 8.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.5.APPENDIX A Clause 60601-1:2005 Topic 3.5 Separation of parts 8.3 Management Responsibilities 3.1 PATIENT CONNECTIONS intended to deliver current 8.4.3 PATIENT leads 8. power source 8.4 WORKING VOLTAGE 8.5.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.2.5.

7.4 Measurements 8.7.6 Measurement of the TOUCH CURRENT 8.1 General Distance through solid insulation or use of thin sheet 8.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.2 Risk Management Process 3.8.7.4 8.4.4.6.7.4.3 8.2 Measuring supply circuits 8.8.8.1 General 8.8.7 Measurement of the PATIENT LEAKAGE CURRENT 8.6.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.6.2 material 8.1 Applicability of requirements 8.6.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.7 CURRENTS 8.5 Risk Management Plan Protective earthing.2 SINGLE FAULT CONDITIONS 8.7.4.1 General requirements 8.5 Measurement of the EARTH LEAKAGE CURRENT 8.7.7.7.4 Measuring device (MD) 8.4 Qualification of Personnel 3.8 FUNCTIONAL EARTH TERMINAL 8.7.7 POTENTIAL EQUALIZATION CONDUCTOR 8.6.6.4.4.4.4 Insulation other than wire insulation 8.8 Measurement of the PATIENT AUXILIARY CURRENT 8.5 8.4.3 Management Responsibilities 3.1 Mechanical strength and resistance to heat 6/120 .6 equalization of ME Equipment 8.3 Dielectric strength 8. functional earthing and potential 8.APPENDIX A Clause 60601-1:2005 Topic 3.6.3 Connection to the measuring supply circuit 8.6.8.8 Insulation 8.7.4.7.3 Allowable values 8.6.7.7.4.2 PROTECTIVE EARTH TERMINAL 8.

9.1.9.9.10.1.9.3 Connections between different parts of ME EQUIPMENT 7/120 .8 8.1.15 DEFIBRILLATION-PROOF APPLIED 8.10.9.9.9.9.2 Application 8.9.9 8.APPENDIX A Clause 60601-1:2005 Topic 3.1 8.4 Qualification of Personnel 3.1.9.11 8.3.9.5 8.1.9.9.9.4.9.1.1.1 General Insulating compound forming solid insulation between 8.3 other insulating parts 8.1.9. mica.9 8.9.1.1.9.9.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass. ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS 8.1.5 Risk Management Plan 8.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c.3.1.10' Components and wiring 8.4 CLEARANCES 8.1.10.1.7 8.2 8.3.1.1 Fixing of components 8.9.8.1 8.3 8.9.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.2 conductive parts Insulating compound forming a cemented joint with 8.2 8.9. Minimum CREEPAGE DISTANCES for two MEANS OF 8.2 Fixing of wiring 8.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.2 Risk Management Process 3.3 Management Responsibilities 3.4 8.9.3 Spaces filled by insulating compound 8.10 8.6 8.3.

3 8.4 8.11.7 8.2.2.11.2 8.11.11.11.4.3 8.2.4.2.5 8.3.4 8.10.2 9.11.2.10.4.3 TRAPPING ZONE General Gaps Safe distances 8/120 .1 8.3.2 Connection cords 8.11 8.11.11.11.3 Management Responsibilities 3.2.11.11. components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection 8.2 8.11.4 foot-operated control devices 8.4.6 8.2 Risk Management Process 3.3.10.2.1 9.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts 9.5 Risk Management Plan Cord-connected HAND-HELD parts and cord-connected 8.APPENDIX A Clause 60601-1:2005 Topic 3.3.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS.1 8.2.3 8.1 9.5 Mains fuses and OVER-CURRENT RELEASES 8.5 Mechanical protection of wiring 8.11.6 9 9.1 General 9.4.1 Limitation of operating voltages 8.4.11.10.10.10.4.11.6 8.3.2 9.4 Qualification of Personnel 3.2 8.11.3.11 8.4 8.

4.2.5 Continuous activation 9.4.2.4.2.2.4.4. corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels 9.4 GUARDS and protective measures 9.3 9.2.2.2.6 Speed of movement(s) 9.2.1 9.2.3 Movable GUARDS 9.2.4.2.4 9.2 Overtravel 9.4.2.2.4 Protective measures 9.3.3 Movement over a threshold 9/120 .4.3 Management Responsibilities 3.4.APPENDIX A Clause 60601-1:2005 Topic 3.2.2.4 Emergency stopping devices 9.5 Risk Management Plan 9.1 General 9.2.2.4.2 9.2.5 Release of PATIENT 9.4.2.2.2.4 Qualification of Personnel 3.2 Force for propulsion 9.2 Risk Management Process 3.2.4.2.4 HAZARD associated with surfaces.2.2.1 9.4.3.3 9.1 Unintended movement 9.1 Access to TRAPPING ZONES 9.2 9.4.2.2 FIXED GUARDS 9.4.3 Other HAZARDS associated with moving parts 9.4.

2 Instability excluding transport 9.7.8.1 Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General 10/120 .4 Grips and other handling devices 9.3 Management Responsibilities 3.6 Pressure-control device 9.7.2 Cathode ray tubes Acoustic energy (including infra.8 9.7 hydraulic pressure 9.2 Pneumatic and hydraulic parts 9.1 Instability in transport 9.4.5 Risk Management Plan Instability from unwanted lateral movement (including 9.6 vibration 9.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.8 9.2.1 General 9.3.4.6.2 Infrasound and ultrasound energy 9.6.6.2.3 sliding) 9.7.1 Audible acoustic energy 9.1 General 9.7.4.7.7.2 Acoustic energy 9.4.3.5 Pressure vessels 9.5.6.6.4 Qualification of Personnel 3.4 Pressure rating of ME EQUIPMENT parts 9.7.7 9.7.2 Risk Management Process 3.5 Expelled parts HAZARD 9.1 Protective means 9.5.and ultrasound) and 9.APPENDIX A Clause 60601-1:2005 Topic 3.3 Maximum pressure 9.

8.8.2 radiation 10.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.4 Lasers and light emitting diodes (LEDs) 10.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.8.3 activation 9.5 Other visible electromagnetic radiation 10.8.8.5 Risk Management Plan 9.1.8. gamma.1 General 9.3 suspension systems 9.1.1 General Use after activation of a MECHANICAL PROTECTIVE 9. neutron and other particle 10.2 therapeutic X-radiation Alpha.4.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.3.4.8.6 Infrared radiation 11/120 .8.3 Microwave radiation 10.3.APPENDIX A Clause 60601-1:2005 Topic 3.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.3 Dynamic forces due to loading from persons 9.4 Qualification of Personnel 3.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.3 Management Responsibilities 3.4. beta.2 Static forces due to loading from persons 9.2 Risk Management Process 3.8.3.

4 Qualification of Personnel 3.1.1 Table 24 Skin contact with AP 11.1.APPENDIX A Clause 60601-1:2005 Topic 3.1 APPLIED PARTS intended to supply heat to a PATIENT 11.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.3 Management Responsibilities 3.2 with OXYGEN RICH ENVIRONMENTS 12/120 .1 Excessive temperatures in ME EQUIPMENT 11.1.2.3 Measurements 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.5 Risk Management Plan 10.2.1.1.1 Table 23 Parts likely to be touched 11.1.1.2 APPLIED PARTS not intended to supply heat to a PATIENT 11.2 Temperature of APPLIED PARTS 11.2 Risk Management Process 3.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.2.4 GUARDS 11.

2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2.4 Leakage Ingress of water or particulate matter into ME 11.2 Risk Management Process 3.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents 11. spillage.3 11.6.4 11.6.2.8 Compatibility with substances used with the ME EQUIPMENT 11.4 Qualification of Personnel 3.APPENDIX A Clause 60601-1:2005 Topic 3.2 Overflow in ME EQUIPMENT 11.2.6.6.2.2. ingress of water or particulate matter.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11.5 Risk Management Plan 11.1 RISK of fire in an OXYGEN RICH ENVIRONMENT External exhaust outlets for OXYGEN RICH 11. leakage.1 General 11.5 Overflow.6.6.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS 13/120 .6. sterilization and compatibility with substances used with the ME 11.6 EQUIPMENT 11.3 11. cleaning.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11. disinfection.3 Management Responsibilities 3.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.6.2.6 SYSTEMS 11.2.

4 Protection against hazardous output 12.4 Qualification of Personnel 3.2 13.4.4 13.1 Limits 12.4.2 Risk Management Process 3.2 Diagnostic X-ray equipment 12.5.5.4.3 Accidental selection of excessive output values 12.4.1.2 Indication of parameters relevant to safety 12.6 13 13.4.3 Alarm systems 12.1.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.1. deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS 14/120 .5 Risk Management Plan Interruption of the power supply / SUPPLY MAINS to ME 11.3 Management Responsibilities 3.3 13.4.1 13.5.1 Accuracy of controls and instruments 12.APPENDIX A Clause 60601-1:2005 Topic 3.4 Incorrect output 12.4 therapeutic radiation 12.2 USABILITY 12.1 Intentional exceeding of safety limits 12.4.1.5.5 Diagnostic or therapeutic radiation 12.4.1 13.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions.4.4.

2.3 13.2 Risk Management Process 3.5 14.4 13.8 Locking of moving parts 13.8 Architecture 15/120 .5 Risk Management Plan 13.13.1 13.2 RISK CONTROL 14.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.7 Impairment of cooling that could result in a HAZARD 13.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices 13.6.2.2.13.2.2.4 Qualification of Personnel 3.2 ME EQUIPMENT with heating elements 13.13.2.3 14.2.2.1 General 14.4 14.7 Requirement specification 14.2.2 Documentation 14.13 Overload 13.2.3 Management Responsibilities 3.2.2 13.4 OPERATION 14 Programmable electrical medical systems 14.13.2.6 Leakage of liquid 13.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.1 Identification of known and foreseeable HAZARDS 14.6.12 HAZARD 13.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.2.2.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS 14.2.1 General overload test conditions 13.2.2.APPENDIX A Clause 60601-1:2005 Topic 3.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.

3.3.2 PORTABLE ME EQUIPMENT 15.3 Management Responsibilities 3.6 Mould stress relief test 15.2 Risk Management Process 3.3.7 Environmental influences 15.3 Mechanical strength 15.2 Push test 15.4.1 EQUIPMENT 15.4.3.3.3.1 HAND-HELD ME EQUIPMENT 15.4 Qualification of Personnel 3.3.3 Impact test 15.3.4.APPENDIX A Clause 60601-1:2005 Topic 3.4.4 ME EQUIPMENT components and general assembly 15.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.5 Risk Management Plan 14.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.5 Rough handling test 15.3.2 Temperature and overload control devices 16/120 .10' VERIFICATION 14.1 Construction of connectors 15.11 PEMS VALIDATION 14.1 General 15.9 Design and implementation 14.4 Drop test 15.2 Serviceability 15.

4.2 Connection 15.8 Internal wiring of ME EQUIPMENT 15.2 Risk Management Process 3.10.4) 15.9 Oil containers 17/120 .3.4.3 Management Responsibilities 3.1 15.4.2 Accidental operation of ME EQUIPMENT 15.2.6.4.7.4 Qualification of Personnel 3.4.2 15.3.5 15.6.4.4.1 Mechanical strength 15.2 Temperature settings 15.7 devices (see also 8. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4.3.4.4.7.6 15.4 Lithium batteries 15.4.3.2.3 Protection against overcharging 15.7.5 Risk Management Plan 15.APPENDIX A Clause 60601-1:2005 Topic 3.4.4.4.5 Excessive current and voltage protection 15.4.4.3 Batteries 15.4.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing.4.3 Entry of liquids 15.1 Application 15.3.4.1 Housing 15.

5.5.5 Medical electrical systems 16.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.3 16.1.3 15.4 16.1.9.1 15.3 Protection of conductors Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 18/120 .4 Qualification of Personnel 3.1 16.1.9 16.5 Risk Management Plan 15.5.4.2 16.9.6.2 15.8 16.2 16.2 16.6.3 16 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.6 16.6.7 16.9.4.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.2 16.5.2.6.4 16.6.2.5 16.1 16.5.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.9.3 16. components and layout MULTIPLE SOCKET-OUTLET 16.1 16.2.APPENDIX A Clause 60601-1:2005 Topic 3.1 16.2 15.9.5.6.1 15.3 Management Responsibilities 3.5 15.2 Risk Management Process 3.

3 G.3.1.3.2.5 G. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT.3 G.2 Risk Management Process 3.2 G.5 G.2 G.1 G.3.1 Introduction Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.4 ANAESTHETIC MIXTURE WITH AIR G.4. parts and components thereof General Power supply G.2.3.2 G.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.3 G.1.1 G.4.2 G.APPENDIX A Clause 60601-1:2005 Topic 3.2.5 G.6 G.5.2 G.3 G.6.4 G.2.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking.4.5 Risk Management Plan Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.1 G.6.4 Qualification of Personnel 3.4.1 G.1.5.4 G.4 G.2.4 G.5 G.1 G.5.1 G.5.2 19/120 .3 Management Responsibilities 3.5.3 G.3.

6.4 Qualification of Personnel 3.3 Temperatures and low-energy circuits G.2 Risk Management Process 3.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required 20/120 .5 Risk Management Plan G.6.APPENDIX A Clause 60601-1:2005 Topic 3.4 Heating elements G.3 Management Responsibilities 3.

6 4 4.1 Source of power for ME EQUIPMENT 4. atmospheric pressure 5.2 Test hook 5.1 4.3 ESSENTIAL PERFORMANCE 4.9.9 PARTS 5.6 Repairs and modifications 5.9.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples 5.9.11 5 5.5 frequency 5.APPENDIX A Clause 60601-1:2005 Topic 3. 5.2 Risk Management File 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.10.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.1 5.2.3 Ambient temperature.4 EXPECTED SERVICE LIFE Risk Analysis Risk Analysis Process Intended Use 4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.9.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.1 Test finger 5.9.2 ACCESSIBLE PARTS 5.3 Actuating mechanisms 21/120 . nature of supply.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4. type of current. humidity.2 ME SYSTEMS 4.6 PATIENT 4.9 CHARACTERISTICS in ME EQUIPMENT 4.4 Other conditions Supply voltages.2.7 Humidity preconditioning treatment 5.1 APPLIED PARTS 5.10' Power supply 4.2.2 4.

2 7.2. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.2.10 7.16 22/120 .2.8.14 7.6 4 4.1 7.2.6 7.2.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable Risk Analysis Risk Analysis Process Intended Use 7.15 7.2.1.2.13 7.2 Protection against electric shock Protection against harmful ingress of water or 6.2.2.4 6.7 7.3 7.2.2.2 Risk Management File 6 Classification 6.4 Method(s) of sterilization 6.12 7.2.2 Identification 7.3 particulate matter 6.3 Consult ACCOMPANYING DOCUMENTS 7.1 General 6. marking and documents General USABILITY of the identification.9 7.8.2.5 6.2.1.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification.2 7.1.1 7.2.APPENDIX A Clause 60601-1:2005 Topic 3.1 7.2.5 7.2.11 7.6 7 7.2.2 7.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability 7.1 4.8 7.

6.7 Supply terminals 7.3.8.3 EQUIPMENT parts (see also Table C.2 Control devices 7.4 7.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.7.1 Heating elements or lampholders 7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights 23/120 .6.1 4.7.6.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.2 Risk Management File Risk Analysis Risk Analysis Process Intended Use 7.1 Power switches 7.3.3 Units of measure 7.2 7.3.2 7.2.3) 7.1 7.3.4.4 C.4.2 HIGH VOLTAGE parts 7.3.2.6 FUNCTIONAL EARTH TERMINALS 7.3 7.1 7.3.3.3.7.APPENDIX A Clause 60601-1:2005 Topic 3.5 7.17 7.6 7.2.4.7.2) 7.5 PROTECTIVE EARTH TERMINALS 7.3 7. THERMAL CUT-OUTS and OVER-CURRENT 7.4 RELEASES 7.7.18 7.7 7.8 7.6 4 4.19 7.3 Batteries Fuses.2.5 7.

9.10 7.2.2.1 7.9.3.9.9 7.16 7.APPENDIX A Clause 60601-1:2005 Topic 3.9.2. disinfection and sterilization Maintenance ACCESSORIES.9.14 material 7.1 Environmental protection Reference to the technical description Technical description (see also Table C.3.5 7.3.2 other parts 7.9.9.2.9. 7.9.9. used 7.1 4.8 7.9.2 Risk Management File 7.9.2.2 7.15 7.3.2.2.6 4 4.3 7.9.2.9.2.3 Circuit diagrams.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.1 Fundamental rule of protection against electric shock 8.6) General Replacement of fuses.9.2.2.9. component part lists.4 Electrical power source ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.2.2.6 7.11 7.9.2.2.9.2 7. etc.1 7.3 power supply 7. supplementary equipment.9.13 7.2 Requirements related to power sources 8.9.8.2.1 Connection to a separate power source 24/120 .2.9.12 7.9 ACCOMPANYING DOCUMENTS Risk Analysis Risk Analysis Process Intended Use General (see also Table C.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.9.7 7. POWER SUPPLY CORDS and 7.2 Colours of controls 7.4) Instructions for use (see also Table C.9.

1. power source Risk Analysis Risk Analysis Process Intended Use 8.4 WORKING VOLTAGE 8.5.3 PATIENT leads 8. current or energy 8.1 Defibrillation protection 8.1 MEANS OF PROTECTION (MOP) 8.5.5.5.2.1 4.3 MAXIMUM MAINS VOLTAGE 8.1 PATIENT CONNECTIONS intended to deliver current 8.2 8.2 Risk Management File 8.1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS 8.5.5.1.2 8.4.5.1 8.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.2 TYPE B APPLIED PARTS 8.2.4.5.4.4 Limitation of voltage.3 source by a plug 8.APPENDIX A Clause 60601-1:2005 Topic 3.5.5.2 Connection to an external d.5 Separation of parts 8.4 Internal capacitive circuits 8.5.2.3 Classification of APPLIED PARTS 8.1.4.2.6 4 4.5.2 Energy reduction test 25/120 .5.3 8.c.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.5.

4 Insulation other than wire insulation 8.6.3 Connection to the measuring supply circuit 8.4.6.4.8 FUNCTIONAL EARTH TERMINAL 8.7.7.4 Measurements 8.4.1 4.2 material 8.7.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.4.7 Measurement of the PATIENT LEAKAGE CURRENT 8.4.1 General requirements 8.6 4 4.3 Dielectric strength 8.4.7.2 Measuring supply circuits 8.6.7.1 General Distance through solid insulation or use of thin sheet 8.7.8.8.2 PROTECTIVE EARTH TERMINAL Risk Analysis Risk Analysis Process Intended Use 8.5 Measurement of the EARTH LEAKAGE CURRENT 8.5 8.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.7.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.8.4 Measuring device (MD) 8.7.6 equalization of ME Equipment 8. functional earthing and potential 8.4.6.7.8.7.6.6.7.APPENDIX A Clause 60601-1:2005 Topic 3.6.4.6.8 Measurement of the PATIENT AUXILIARY CURRENT 8.4.7 CURRENTS 8.6 Measurement of the TOUCH CURRENT 8.3 Allowable values 8.7.4 8.1 Applicability of requirements 8.1 General 8.2 Risk Management File Protective earthing.7.7 POTENTIAL EQUALIZATION CONDUCTOR 8.2 SINGLE FAULT CONDITIONS 8.8 Insulation 8.6.3 8.4.8.1 Mechanical strength and resistance to heat 26/120 .

9.9.10.9.9.1.3 Connections between different parts of ME EQUIPMENT 27/120 .15 DEFIBRILLATION-PROOF APPLIED 8.9.1.9 8.9.3.9. ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS Risk Analysis Risk Analysis Process Intended Use 8.1.3. Minimum CREEPAGE DISTANCES for two MEANS OF 8.3 8.2 8.11 8.10' Components and wiring 8.1.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass.9.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.1 General Insulating compound forming solid insulation between 8.8 8. mica.9.1 8.9.9.1.8.9.9.9 8.3 other insulating parts 8.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.1.6 8.1.6 4 4.c.1 8.1.10 8.2 Risk Management File 8.9.1.2 Application 8.9.1.2 Fixing of wiring 8.1.2 conductive parts Insulating compound forming a cemented joint with 8.1.10.5 8.1 4.4.1.7 8.9.3 Spaces filled by insulating compound 8.9.9.APPENDIX A Clause 60601-1:2005 Topic 3.2 8.4 8.4 CLEARANCES 8.9.9.9.10.9.9.3.1 Fixing of components 8.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.3.

3.7 8.3 TRAPPING ZONE General Gaps Safe distances 28/120 .3 8.2 8.3 8.11.11.11.1 General 9.2 Connection cords Risk Analysis Risk Analysis Process Intended Use 8.3.11.1 9.11.11.11.3 8.4.2.2 8.APPENDIX A Clause 60601-1:2005 Topic 3.11.10.11.2.2 Risk Management File Cord-connected HAND-HELD parts and cord-connected 8.10.4.10.2.11.4.6 8.3.4 8.3.5 Mains fuses and OVER-CURRENT RELEASES 8.2.11 8.4.2 9.10.4. components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection 8.4.1 Limitation of operating voltages 8.1 8.11.11.6 4 4.5 Mechanical protection of wiring 8.2.11.6 9 9.5 8.1 9.2 9.2 8.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS.11.1 8.4 8.4 8.2.2.3.6 8.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts 9.10.4.4 foot-operated control devices 8.10.11 8.1 4.2.11.3.11.

2.3 Movable GUARDS 9.2.6 Speed of movement(s) 9.4.2.4.4.2 9.2.4.2.3.2.2.2 Force for propulsion 9.2.2.2.4 GUARDS and protective measures 9.4.2 Overtravel 9.4.2.3 Other HAZARDS associated with moving parts 9.3 9.3 Movement over a threshold 29/120 .3 9.2.2.4.4.2. corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels 9.2.5 Release of PATIENT 9.2.4.4.2 9.4 9.2.1 General 9.4 Protective measures 9.APPENDIX A Clause 60601-1:2005 Topic 3.2.4.2.6 4 4.2.2.2.1 Unintended movement 9.4.4.2.4.4.4 Emergency stopping devices 9.2.1 9.2 FIXED GUARDS Risk Analysis Risk Analysis Process Intended Use 9.1 9.3.2.2.1 Access to TRAPPING ZONES 9.1 4.5 Continuous activation 9.4 HAZARD associated with surfaces.2 Risk Management File 9.4.

3.4.APPENDIX A Clause 60601-1:2005 Topic 3.6 vibration 9.7.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.6.6.2 Instability excluding transport 9.5.2 Infrasound and ultrasound energy 9.2.8 9.6.6.7 9.4.6 Pressure-control device 9.4.7.3.7.2 Acoustic energy 9.1 Audible acoustic energy 9.8 9.4 Grips and other handling devices 9.1 General 9.8.1 Instability in transport 9.4.7.5 Pressure vessels 9.2 Pneumatic and hydraulic parts 9.2 Risk Management File Instability from unwanted lateral movement (including 9.7.1 Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General 30/120 .7.7.6.2 Cathode ray tubes Acoustic energy (including infra.7.1 General 9.1 Protective means 9.1 4.7 hydraulic pressure 9.3 sliding) 9.2.3 Maximum pressure 9.5 Expelled parts HAZARD Risk Analysis Risk Analysis Process Intended Use 9.4 Pressure rating of ME EQUIPMENT parts 9.6 4 4.5.and ultrasound) and 9.

3 activation 9.6 4 4.1 General Use after activation of a MECHANICAL PROTECTIVE 9.8.8.4 Lasers and light emitting diodes (LEDs) 10.3.4.8. beta.4.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.APPENDIX A Clause 60601-1:2005 Topic 3.3 Dynamic forces due to loading from persons 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.3.8.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.1 4.8.2 therapeutic X-radiation Alpha. neutron and other particle 10.3 Microwave radiation 10.5 Other visible electromagnetic radiation 10.8.4.2 Static forces due to loading from persons 9.3.8.1 General 9.2 radiation 10.1.1.3 suspension systems Risk Analysis Risk Analysis Process Intended Use 9.6 Infrared radiation 31/120 .8. gamma.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.2 Risk Management File 9.8.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.

4 GUARDS 11.1 Excessive temperatures in ME EQUIPMENT 11.2 Temperature of APPLIED PARTS 11.1 4.1.1.1.1.2 APPLIED PARTS not intended to supply heat to a PATIENT 11.2.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.1 Table 23 Parts likely to be touched 11.2 Risk Management File Risk Analysis Risk Analysis Process Intended Use 10.2.1 APPLIED PARTS intended to supply heat to a PATIENT 11.2 with OXYGEN RICH ENVIRONMENTS 32/120 .1 Table 24 Skin contact with AP 11.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.1.2.1.3 Measurements 11.APPENDIX A Clause 60601-1:2005 Topic 3.1.6 4 4.

1 4. ingress of water or particulate matter.8 Compatibility with substances used with the ME EQUIPMENT 11.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11.6.2 Overflow in ME EQUIPMENT 11.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11. spillage.1 RISK of fire in an OXYGEN RICH ENVIRONMENT External exhaust outlets for OXYGEN RICH 11.APPENDIX A Clause 60601-1:2005 Topic 3.5 Overflow.6 EQUIPMENT 11.4 Leakage Ingress of water or particulate matter into ME 11.3 11.6.2.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2. leakage.2.6.6 4 4.4 11.6. disinfection.2.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents 11.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS 33/120 .1 General 11.6.3 11.6 SYSTEMS 11.2.6.2.6.6.2 Risk Management File Risk Analysis Risk Analysis Process Intended Use 11. sterilization and compatibility with substances used with the ME 11.2. cleaning.

5.4.1.1.3 Accidental selection of excessive output values 12.1.5.APPENDIX A Clause 60601-1:2005 Topic 3.4 Incorrect output 12.1 Limits 12.2 Diagnostic X-ray equipment 12. deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS 34/120 .6 13 13.1 Intentional exceeding of safety limits 12.1 13.1 4.4.2 USABILITY 12.1 Accuracy of controls and instruments 12.4.4.5 Diagnostic or therapeutic radiation 12.4 Protection against hazardous output Risk Analysis Risk Analysis Process Intended Use 12.3 Alarm systems 12.4.1.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions.1 13.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.4.4.2 Risk Management File Interruption of the power supply / SUPPLY MAINS to ME 11.2 13.4.5.5.4.2 Indication of parameters relevant to safety 12.3 13.4 13.4 therapeutic radiation 12.4.6 4 4.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.

7 Requirement specification 14.6.1 General overload test conditions 13.2 Risk Management File 13.13.2.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.2.13.1 Identification of known and foreseeable HAZARDS 14.13.2 Documentation 14.2.2.2.8 Locking of moving parts 13.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS 14.6 4 4.6 Leakage of liquid 13.13 Overload 13.2.6.2.5 14.8 Architecture 35/120 .1 4.13.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.2.4 13.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices Risk Analysis Risk Analysis Process Intended Use 13.2.3 14.2.2 13.2.2.1 13.2.2 RISK CONTROL 14.2.2 ME EQUIPMENT with heating elements 13.3 13.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.2.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.4 14.4 OPERATION 14 Programmable electrical medical systems 14.2.2.1 General 14.7 Impairment of cooling that could result in a HAZARD 13.APPENDIX A Clause 60601-1:2005 Topic 3.12 HAZARD 13.

1 4.3.3.4 Drop test 15.4.4.3.1 EQUIPMENT 15.10' VERIFICATION Risk Analysis Risk Analysis Process Intended Use 14.3 Impact test 15.4 ME EQUIPMENT components and general assembly 15.1 HAND-HELD ME EQUIPMENT 15.3.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.7 Environmental influences 15.4.3.1 General 15.11 PEMS VALIDATION 14.3.3.3.APPENDIX A Clause 60601-1:2005 Topic 3.6 Mould stress relief test 15.2 Risk Management File 14.2 Temperature and overload control devices 36/120 .2 PORTABLE ME EQUIPMENT 15.1 Construction of connectors 15.2 Push test 15.6 4 4.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.9 Design and implementation 14.2 Serviceability 15.5 Rough handling test 15.3 Mechanical strength 15.4.3.

4.1 Housing 15.6 15.3.4.4.2 Temperature settings 15.4 Lithium batteries 15.7 devices (see also 8.4.9 Oil containers 37/120 .3.4.2 15.2 Accidental operation of ME EQUIPMENT 15.5 Excessive current and voltage protection 15.6.6. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4.7.3 Entry of liquids 15.4.5 15.4.1 15.1 4.4.4.4.1 Mechanical strength 15.4.4.4.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing.4.8 Internal wiring of ME EQUIPMENT 15.3.3.6 4 4.7.4.3 Batteries 15.2 Connection 15.2 Risk Management File Risk Analysis Risk Analysis Process Intended Use 15.2.1 Application 15.4.3.4.APPENDIX A Clause 60601-1:2005 Topic 3.4.10.3 Protection against overcharging 15.2.7.4) 15.

4 16.6.6 16.2 Risk Management File MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.2.4.9.6.5 15.8 16.APPENDIX A Clause 60601-1:2005 Topic 3.3 16.2 16.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.3 16 16.9 16.2 16.1 16.2.1.2 15.6.9.6. components and layout MULTIPLE SOCKET-OUTLET 16.9.7 16.1 15.9.6.3 Protection of conductors Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 38/120 .4.3 16.1 16.1 15.2 16.5.3 15.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.2 15.2.9.6.2 16.1.5.5.1 16.5.5 Medical electrical systems Risk Analysis Risk Analysis Process Intended Use 15.5.5.1 4.1.5 16.1 16.4 16.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.6 4 4.

6 G.3.1 G.2 Risk Management File Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.1. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.1 4.2.6 4 4.1 G.3.APPENDIX A Clause 60601-1:2005 Topic 3.1 Introduction Risk Analysis Risk Analysis Process Intended Use Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.2.1 G.5.4 ANAESTHETIC MIXTURE WITH AIR G.1 G.1 G.6.3.5 G.2 G.3 G.2 G.2.1.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.5 G.3.1.3 G.2 G.2 G.3 G.4.2.3.5 G.2 39/120 .5 G.3 G.2 G.4 G.4 G.4 G.1 G.6.2.4 G.5.5.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking. parts and components thereof General Power supply G.4.5.5.4.3 G.4.

6 4 4.6.6.APPENDIX A Clause 60601-1:2005 Topic 3.3 Temperatures and low-energy circuits G.4 Heating elements G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required Risk Analysis Risk Analysis Process Intended Use 40/120 .2 Risk Management File G.1 4.

7 Humidity preconditioning treatment 5. 5.APPENDIX A Clause 60601-1:2005 Topic 4.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.6 PATIENT 4. type of current.9.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples 5.6 Repairs and modifications 5.3 Actuating mechanisms 41/120 .10' Power supply 4.2.1 Test finger 5.1 5.2 ME SYSTEMS 4.4 Other conditions Supply voltages.9 CHARACTERISTICS in ME EQUIPMENT 4.9.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.9 PARTS 5.11 5 5. nature of supply.9.2 Test hook 5.5 frequency 5.3 Identification of Hazards 4.10.3 ESSENTIAL PERFORMANCE 4.1 APPLIED PARTS 5.2 ACCESSIBLE PARTS 5.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.9.2 4.4 EXPECTED SERVICE LIFE 4.9. atmospheric pressure 5.2. humidity.2.3 Ambient temperature.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.1 Source of power for ME EQUIPMENT 4.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.10.

1 General 6.2.1 7.APPENDIX A Clause 60601-1:2005 Topic 4.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification.2.2.10 7.3 7.2 Identification 7.8.1 7.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable 7.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 6 Classification 6.2.2.2.2.11 7.2.13 7.4 Method(s) of sterilization 6.5 7.2.2.2 Protection against electric shock Protection against harmful ingress of water or 6.7 7.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability 7.16 42/120 .12 7.2 7.3 particulate matter 6.9 7.1 7.2. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.3 Identification of Hazards 4.8. marking and documents General USABILITY of the identification.15 7.2.2.8 7.2.1.2.6 7 7.3 Consult ACCOMPANYING DOCUMENTS 7.4 6.14 7.2 7.5 6.2 7.6 7.1.1.2.2.2.

THERMAL CUT-OUTS and OVER-CURRENT 7.3.3 Batteries Fuses.6 7.7.3.2.3 Identification of Hazards 4.2.7.7.4.2.4 C.2.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.3.2 Control devices 7.5 7.3 EQUIPMENT parts (see also Table C.7.3 7.17 7.7 Supply terminals 7.4.2 7.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.5 7.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 7.3.2) 7.3.3.1 Heating elements or lampholders 7.2 HIGH VOLTAGE parts 7.1 7.4 7.3 Units of measure 7.8 7.18 7.APPENDIX A Clause 60601-1:2005 Topic 4.3 7.6 FUNCTIONAL EARTH TERMINALS 7.1 Power switches 7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights 43/120 .3) 7.5 PROTECTIVE EARTH TERMINALS 7.7.6.4 RELEASES 7.6.19 7.6.4.7 7.2 7.8.3.3.1 7.

2.9.2 7.9.9.1 Fundamental rule of protection against electric shock 8. used 7.2.9.9.2.3 Identification of Hazards 4.2.1 7.2 7.9.9.9. 7.8 7.2.9.3 7.7 7.9.4) Instructions for use (see also Table C.4 Electrical power source ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.1 Environmental protection Reference to the technical description Technical description (see also Table C.2. disinfection and sterilization Maintenance ACCESSORIES.9.9.9.14 material 7.2.9.2.2.2.2. etc.2.2.2 Colours of controls 7.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.3 Circuit diagrams.6 7.9 7. POWER SUPPLY CORDS and 7.5 7.2.2 Requirements related to power sources 8.3.9.2.9.3 power supply 7.9.13 7.2.3.2.16 7.9. component part lists.3.8.9.3.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 7.APPENDIX A Clause 60601-1:2005 Topic 4.11 7.9.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.9 ACCOMPANYING DOCUMENTS General (see also Table C.10 7.12 7.9.6) General Replacement of fuses.15 7.2 other parts 7.1 7. supplementary equipment.1 Connection to a separate power source 44/120 .9.9.

4 Internal capacitive circuits 8.4.2 Connection to an external d.5.1 MEANS OF PROTECTION (MOP) 8.5.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 8.2 TYPE B APPLIED PARTS 8.2 8.5.3 8.3 Classification of APPLIED PARTS 8.5.1 8.5.4.1. power source 8.APPENDIX A Clause 60601-1:2005 Topic 4.5.4 WORKING VOLTAGE 8.5.2 Energy reduction test 45/120 .c. current or energy 8.5.1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS 8.1.5.2.3 Identification of Hazards 4.4.3 source by a plug 8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.2.5.1.4 Limitation of voltage.2.2.5.1 Defibrillation protection 8.5.2 8.4.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.1 PATIENT CONNECTIONS intended to deliver current 8.5.5 Separation of parts 8.3 MAXIMUM MAINS VOLTAGE 8.3 PATIENT leads 8.5.

7.4 Measurements 8.4.1 Mechanical strength and resistance to heat 46/120 .8 Measurement of the PATIENT AUXILIARY CURRENT 8.7.1 General requirements 8.4.4.3 8.7 POTENTIAL EQUALIZATION CONDUCTOR 8.7.4.5 Measurement of the EARTH LEAKAGE CURRENT 8.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.7.4.6.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT 8.1 Applicability of requirements 8.2 Measuring supply circuits 8.8 Insulation 8.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control Protective earthing.6.6.8.4 Insulation other than wire insulation 8.6.6.7.6.8.7.3 Dielectric strength 8.7.4.2 material 8.6.6.2 SINGLE FAULT CONDITIONS 8.6 equalization of ME Equipment 8.4.6 Measurement of the TOUCH CURRENT 8.5 8.1 General 8.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.3 Connection to the measuring supply circuit 8.7.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.7.8.8.8 FUNCTIONAL EARTH TERMINAL 8.2 PROTECTIVE EARTH TERMINAL 8.3 Allowable values 8.7.1 General Distance through solid insulation or use of thin sheet 8.3 Identification of Hazards 4.4 8.6.7.4. functional earthing and potential 8.7 CURRENTS 8.4.4 Measuring device (MD) 8.7.APPENDIX A Clause 60601-1:2005 Topic 4.8.

1.9 8.9.3 Identification of Hazards 4.3.9. mica.9.9.10. ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS 8.9.1.9.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 8.1.9.9.3.10' Components and wiring 8.3 Connections between different parts of ME EQUIPMENT 47/120 .1 8.11 8.1.9.9.1.5 8.9.1.4 CLEARANCES 8.15 DEFIBRILLATION-PROOF APPLIED 8.1.9.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.2 8.1 General Insulating compound forming solid insulation between 8.9 8.9.9.3.1. Minimum CREEPAGE DISTANCES for two MEANS OF 8.2 conductive parts Insulating compound forming a cemented joint with 8.9.8.10.1 8.1.2 Application 8.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass.3.c.10.9.10 8.1.3 Spaces filled by insulating compound 8.2 Fixing of wiring 8.1.9.9.2 8.4.3 8.9.9.1 Fixing of components 8.1.9.1.1.7 8.6 8.9.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.9.8 8.APPENDIX A Clause 60601-1:2005 Topic 4.3 other insulating parts 8.4 8.

2.11.11.10.4 foot-operated control devices 8.10.11.11.2.10.3 8.2. components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection 8.4.3 8.1 8.11 8.4.11.3.5 Mechanical protection of wiring 8.3.3 TRAPPING ZONE General Gaps Safe distances 48/120 .4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control Cord-connected HAND-HELD parts and cord-connected 8.11.2 8.11.11.4.6 8.4.3.2 8.4 8.6 9 9.11.10.2.4.2.10.7 8.1 9.2 8.2 9.2 Connection cords 8.1 9.11.10.4.11.11 8.1 Limitation of operating voltages 8.5 8.1 General 9.5 Mains fuses and OVER-CURRENT RELEASES 8.1 8.3.11.2 9.3 Identification of Hazards 4.4.3.2.11.4 8.4 8.6 8.11.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS.2.11.APPENDIX A Clause 60601-1:2005 Topic 4.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts 9.3 8.3.11.2.

3 Movement over a threshold 49/120 .4.5 Release of PATIENT 9.1 General 9.4 9.2.2.2.3.2 9.APPENDIX A Clause 60601-1:2005 Topic 4.2.4.4.4.2 FIXED GUARDS 9.4.4 Protective measures 9.2.2.2.2.2.2.2.2.4 HAZARD associated with surfaces.2.3 Identification of Hazards 4.3.2.1 Unintended movement 9.1 Access to TRAPPING ZONES 9.4 Emergency stopping devices 9.2.2.4 GUARDS and protective measures 9.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 9.4.2.3 Other HAZARDS associated with moving parts 9.2.4.1 9.6 Speed of movement(s) 9.2.4.2.2.4.4.4.2 9.2 Overtravel 9.2.1 9.4.3 9.4.2.4.2 Force for propulsion 9.2.2.2.4.5 Continuous activation 9.3 9. corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels 9.3 Movable GUARDS 9.4.

7.1 Protective means 9.7.APPENDIX A Clause 60601-1:2005 Topic 4.7.7.7.6 Pressure-control device 9.5 Expelled parts HAZARD 9.1 General 9.6 vibration 9.7 hydraulic pressure 9.4.4.3.6.2 Instability excluding transport 9.1 Audible acoustic energy 9.8 9.4.2.3 sliding) 9.5.2 Cathode ray tubes Acoustic energy (including infra.6.and ultrasound) and 9.1 Instability in transport 9.5.3 Identification of Hazards 4.6.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.6.8.2 Infrasound and ultrasound energy 9.5 Pressure vessels 9.2.7.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control Instability from unwanted lateral movement (including 9.4 Grips and other handling devices 9.7 9.4 Pressure rating of ME EQUIPMENT parts 9.4.1 Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General 50/120 .2 Acoustic energy 9.8 9.7.2 Pneumatic and hydraulic parts 9.7.3.3 Maximum pressure 9.6.1 General 9.

8.8.4.3 suspension systems 9.8.8.2 Static forces due to loading from persons 9.4.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.3.1 General Use after activation of a MECHANICAL PROTECTIVE 9.3 Identification of Hazards 4.4 Lasers and light emitting diodes (LEDs) 10.3.2 therapeutic X-radiation Alpha.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10. beta.3 Dynamic forces due to loading from persons 9.3 activation 9.3 Microwave radiation 10.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.8. gamma. neutron and other particle 10.1 General 9.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.8.4.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 9.1.6 Infrared radiation 51/120 .8.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.APPENDIX A Clause 60601-1:2005 Topic 4.8.8.1.3.2 radiation 10.5 Other visible electromagnetic radiation 10.

1.1 Table 24 Skin contact with AP 11.1.2.1.2 with OXYGEN RICH ENVIRONMENTS 52/120 .1.2 APPLIED PARTS not intended to supply heat to a PATIENT 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.2.2.1 APPLIED PARTS intended to supply heat to a PATIENT 11.1 Excessive temperatures in ME EQUIPMENT 11.2.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.2 Temperature of APPLIED PARTS 11.1.4 GUARDS 11.3 Measurements 11.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.1.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 10.APPENDIX A Clause 60601-1:2005 Topic 4.1.1 Table 23 Parts likely to be touched 11.3 Identification of Hazards 4.

6 EQUIPMENT 11.1 RISK of fire in an OXYGEN RICH ENVIRONMENT External exhaust outlets for OXYGEN RICH 11.8 Compatibility with substances used with the ME EQUIPMENT 11.2.2.5 Overflow.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents 11.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 11.2.2. leakage.6.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS 53/120 .4 Leakage Ingress of water or particulate matter into ME 11.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11.6.3 Identification of Hazards 4.3 11.2.4 11. disinfection.6.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11. spillage.6.APPENDIX A Clause 60601-1:2005 Topic 4. cleaning.6.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.6 SYSTEMS 11. ingress of water or particulate matter.2.3 11.2.1 General 11. sterilization and compatibility with substances used with the ME 11.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11.2 Overflow in ME EQUIPMENT 11.6.6.6.

4.1 Accuracy of controls and instruments 12.1.2 USABILITY 12.4 therapeutic radiation 12.4.2 Indication of parameters relevant to safety 12.2 Diagnostic X-ray equipment 12.6 13 13.4.5.5.4.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.5.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control Interruption of the power supply / SUPPLY MAINS to ME 11.4.5.4 13.1 13.4.1.3 Identification of Hazards 4.4.1 13.3 Alarm systems 12.1 Intentional exceeding of safety limits 12.4 Protection against hazardous output 12.4.5 Diagnostic or therapeutic radiation 12.1 Limits 12. deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS 54/120 .4.1.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions.3 13.2 13.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.4 Incorrect output 12.APPENDIX A Clause 60601-1:2005 Topic 4.4.3 Accidental selection of excessive output values 12.1.

1 General overload test conditions 13.2.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS 14.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.1 Identification of known and foreseeable HAZARDS 14.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.2.6 Leakage of liquid 13.12 HAZARD 13.2.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices 13.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.APPENDIX A Clause 60601-1:2005 Topic 4.2.4 14.7 Impairment of cooling that could result in a HAZARD 13.13.3 14.2.3 13.8 Architecture 55/120 .2.6.2.2.4 OPERATION 14 Programmable electrical medical systems 14.2.2.2.2 RISK CONTROL 14.13.2.2.2.13.2.4 13.1 General 14.13.6.2.7 Requirement specification 14.8 Locking of moving parts 13.5 14.2 13.2 ME EQUIPMENT with heating elements 13.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 13.2 Documentation 14.2.3 Identification of Hazards 4.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.1 13.13 Overload 13.

2 Temperature and overload control devices 56/120 .6 Mould stress relief test 15.1 EQUIPMENT 15.2 Push test 15.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 14.10' VERIFICATION 14.3 Identification of Hazards 4.3.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.4 Drop test 15.3.APPENDIX A Clause 60601-1:2005 Topic 4.1 HAND-HELD ME EQUIPMENT 15.4.5 Rough handling test 15.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.3.3.4.1 Construction of connectors 15.2 Serviceability 15.9 Design and implementation 14.3.3.4.7 Environmental influences 15.4 ME EQUIPMENT components and general assembly 15.11 PEMS VALIDATION 14.3 Mechanical strength 15.4.3 Impact test 15.2 PORTABLE ME EQUIPMENT 15.3.1 General 15.3.3.

5 Excessive current and voltage protection 15.4.6 15.4.3.3.8 Internal wiring of ME EQUIPMENT 15.10.1 15.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing.2.7.4.4.4.3 Identification of Hazards 4.7.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 15.4.1 Housing 15.9 Oil containers 57/120 .6.1 Mechanical strength 15.4.4) 15.4.2 15.4.2 Accidental operation of ME EQUIPMENT 15.3 Batteries 15.2 Connection 15.3 Protection against overcharging 15.5 15.4.3.4.4.3.4.2 Temperature settings 15.4.3 Entry of liquids 15.6.4.4.4.3.4.1 Application 15.7 devices (see also 8.7.4 Lithium batteries 15.2.APPENDIX A Clause 60601-1:2005 Topic 4. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4.

3 15.6 16.9 16.1 15.5.4 16.1.6.9.1 16.4 16.1 16.APPENDIX A Clause 60601-1:2005 Topic 4.2.5 16.3 16 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.6.1 16.6.3 16.2.5 Medical electrical systems 16.6.3 Identification of Hazards 4.3 Protection of conductors Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 58/120 .5.8 16.4.6.7 16.9.3 16.9.5.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.2.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control 15.1.5.1 16.2 16.2 15.1.4.9.1 15.5.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.2 15.9.5 15.2 16.2 16.5.2 16. components and layout MULTIPLE SOCKET-OUTLET 16.6.

4.2 G.1.4 G.3 Identification of Hazards 4.4. parts and components thereof General Power supply G.5 G.4.5.3.3.3 G.1.3 G.5.3.1 G.5.1 G.3 G.1 G.5.3 G.1 G.1 G. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.4.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking.2 G.2 G.5.2. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT.1 Introduction Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.2.2 G.4 G.4 G.2.2.APPENDIX A Clause 60601-1:2005 Topic 4.6 G.5 G.4 ANAESTHETIC MIXTURE WITH AIR G.2 59/120 .3.1.5 G.3.4 G.2.2 G.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.3 G.5 G.6.6.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.1 G.

3 Temperatures and low-energy circuits G.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required 60/120 .4 Heating elements G.6.3 Identification of Hazards 4.APPENDIX A Clause 60601-1:2005 Topic 4.6.4 ISO 14971:2000 Clauses 5 6 Estimation of Risks Risk Evaluation Risk Control G.

type of current.2.1 5. humidity.2 Risk Control Option Analysis 6.6 PATIENT 4.9.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.3 Ambient temperature.2 Test hook 5.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.9 CHARACTERISTICS in ME EQUIPMENT 4.1 Source of power for ME EQUIPMENT 4.10.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.4 Other conditions Supply voltages.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples 5. nature of supply.1 6.4 Residual risk evaluation 6.9.APPENDIX A Clause 60601-1:2005 Topic 6.4 EXPECTED SERVICE LIFE 4.2 ME SYSTEMS 4.2 4.2 ACCESSIBLE PARTS 5.2.9.5 Risk/Benefit Analysis Risk Reduction 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.9.9 PARTS 5.3 ESSENTIAL PERFORMANCE 4.7 Humidity preconditioning treatment 5. atmospheric pressure 5.10.2.3 Actuating mechanisms 61/120 .8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.11 5 5.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.1 Test finger 5.6 Repairs and modifications 5.3 Implementation of risk control measures 6.1 APPLIED PARTS 5.10' Power supply 4.5 frequency 5. 5.9.

3 Implementation of risk control measures 6.9 7.5 7.12 7.2.APPENDIX A Clause 60601-1:2005 Topic 6.2.4 Residual risk evaluation 6.15 7. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.8 7.2.11 7.3 7.2 7.5 Risk/Benefit Analysis Risk Reduction 6 Classification 6.1.2 7.2.1 General 6.13 7.4 Method(s) of sterilization 6.1.2.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable 7.3 particulate matter 6.5 6.10 7.8.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability 7.1 7.2.2.2 Risk Control Option Analysis 6.2 Identification 7.2.14 7.4 6.2.1.2.2.2.8.2 Protection against electric shock Protection against harmful ingress of water or 6.2. marking and documents General USABILITY of the identification.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification.1 7.6 7.1 7.2.2.2 7.2.6 7 7.3 Consult ACCOMPANYING DOCUMENTS 7.2.16 62/120 .2.7 7.1 6.

6.6.2 HIGH VOLTAGE parts 7.4 C.7.5 7.7 7.8.3.3.3.7.3.2 7.5 7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights 63/120 .4 RELEASES 7.7.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.5 Risk/Benefit Analysis Risk Reduction 7.6 7.19 7.2.1 Power switches 7.8 7.4.4.3 7.2.1 Heating elements or lampholders 7.2.3 Units of measure 7.1 6.3 Implementation of risk control measures 6.7.1 7.5 PROTECTIVE EARTH TERMINALS 7.4 7.4 Residual risk evaluation 6.2 7.2 Control devices 7.3 EQUIPMENT parts (see also Table C.2 Risk Control Option Analysis 6.3.3.APPENDIX A Clause 60601-1:2005 Topic 6.2) 7.7 Supply terminals 7.3) 7.1 7.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.4.3 Batteries Fuses.7. THERMAL CUT-OUTS and OVER-CURRENT 7.6 FUNCTIONAL EARTH TERMINALS 7.6.3.18 7.17 7.2.3.3 7.

1 7.2.APPENDIX A Clause 60601-1:2005 Topic 6.2.9.12 7.11 7.15 7.14 material 7.9. component part lists.10 7. etc.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.5 Risk/Benefit Analysis Risk Reduction 7.6 7.1 6.9.2.6) General Replacement of fuses.8 7.2 7.3.8.2.2.9. supplementary equipment.3.9.2 Requirements related to power sources 8. POWER SUPPLY CORDS and 7.2.9.9.2.2 Risk Control Option Analysis 6.3. 7.2.3 power supply 7.2 other parts 7.1 7.9.1 Fundamental rule of protection against electric shock 8.4 Electrical power source ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.9.5 7.9.9.2.16 7.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.7 7.2.1 Connection to a separate power source 64/120 .3 Implementation of risk control measures 6.2 7.9 ACCOMPANYING DOCUMENTS General (see also Table C.9.4) Instructions for use (see also Table C.2.9.9.2.1 Environmental protection Reference to the technical description Technical description (see also Table C.9.3 7.2. disinfection and sterilization Maintenance ACCESSORIES.13 7.9.9.2.9.2.2 Colours of controls 7. used 7.9.9.9.9.2.3.9.3 Circuit diagrams.2.4 Residual risk evaluation 6.9 7.

power source 8.2 8.3 Classification of APPLIED PARTS 8.4 Limitation of voltage.2 TYPE B APPLIED PARTS 8.5 Separation of parts 8.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.1 MEANS OF PROTECTION (MOP) 8.5.c.4 WORKING VOLTAGE 8.4.2.4.3 PATIENT leads 8.5.3 Implementation of risk control measures 6.5.5.1 PATIENT CONNECTIONS intended to deliver current 8.5.5.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.5 Risk/Benefit Analysis Risk Reduction 8.2 Energy reduction test 65/120 .4 Internal capacitive circuits 8.APPENDIX A Clause 60601-1:2005 Topic 6.5.3 MAXIMUM MAINS VOLTAGE 8.2.5.2.4.5.3 source by a plug 8.1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS 8.2 Risk Control Option Analysis 6. current or energy 8.1 6.1.4.2.5.2 8.5.1 8.5.1 Defibrillation protection 8.5.5.3 8.4 Residual risk evaluation 6.1.1.2 Connection to an external d.

7.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.6.6 equalization of ME Equipment 8.7.5 Risk/Benefit Analysis Risk Reduction Protective earthing.7.7.2 Risk Control Option Analysis 6.5 Measurement of the EARTH LEAKAGE CURRENT 8.7.5 8.6.8.7.4.6.8 Measurement of the PATIENT AUXILIARY CURRENT 8.4.4 Residual risk evaluation 6. functional earthing and potential 8.APPENDIX A Clause 60601-1:2005 Topic 6.6.4 Measuring device (MD) 8.2 PROTECTIVE EARTH TERMINAL 8.4.7.3 Implementation of risk control measures 6.1 General 8.4.1 Mechanical strength and resistance to heat 66/120 .6.7.7 CURRENTS 8.8 Insulation 8.4.4.6 Measurement of the TOUCH CURRENT 8.6.4 Measurements 8.4.6.7.7.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.2 SINGLE FAULT CONDITIONS 8.2 Measuring supply circuits 8.4.8 FUNCTIONAL EARTH TERMINAL 8.7.3 8.1 General requirements 8.8.7 Measurement of the PATIENT LEAKAGE CURRENT 8.8.7.1 Applicability of requirements 8.2 material 8.3 Connection to the measuring supply circuit 8.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.6.6.3 Dielectric strength 8.1 6.4.7.7 POTENTIAL EQUALIZATION CONDUCTOR 8.1 General Distance through solid insulation or use of thin sheet 8.4 Insulation other than wire insulation 8.3 Allowable values 8.8.4 8.8.4.

APPENDIX A Clause

60601-1:2005 Topic

6.1

6.2 Risk Control Option Analysis

6.3 Implementation of risk control measures

6.4 Residual risk evaluation

6.5 Risk/Benefit Analysis

Risk Reduction 8.8.4.2 8.9 8.9.1 8.9.1.1 8.9.1.2 8.9.1.3 8.9.1.4 8.9.1.5 8.9.1.6 8.9.1.7 8.9.1.8 8.9.1.9 8.9.1.10 8.9.1.11 8.9.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass, mica, ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS

8.9.1.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.c. Minimum CREEPAGE DISTANCES for two MEANS OF 8.9.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.9.1.15 DEFIBRILLATION-PROOF APPLIED 8.9.2 Application 8.9.3 Spaces filled by insulating compound 8.9.3.1 General Insulating compound forming solid insulation between 8.9.3.2 conductive parts Insulating compound forming a cemented joint with 8.9.3.3 other insulating parts 8.9.3.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.9.4 CLEARANCES 8.10' Components and wiring 8.10.1 Fixing of components

8.10.2 Fixing of wiring 8.10.3 Connections between different parts of ME EQUIPMENT

67/120

APPENDIX A Clause

60601-1:2005 Topic

6.1

6.2 Risk Control Option Analysis

6.3 Implementation of risk control measures

6.4 Residual risk evaluation

6.5 Risk/Benefit Analysis

Risk Reduction Cord-connected HAND-HELD parts and cord-connected 8.10.4 foot-operated control devices 8.10.4.1 Limitation of operating voltages 8.10.4.2 Connection cords

8.10.5 Mechanical protection of wiring

8.10.6 8.10.7 8.11 8.11 8.11.2 8.11.3 8.11.3.1 8.11.3.2 8.11.3.3 8.11.3.4 8.11.3.5 8.11.3.6 8.11.4 8.11.4.1 8.11.4.2 8.11.4.3 8.11.4.4 8.11.4.5

Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS, components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection

8.11.5 Mains fuses and OVER-CURRENT RELEASES 8.11.6 9 9.1 9.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts

9.2.1 General 9.2.2 9.2.2.1 9.2.2.2 9.2.2.3 TRAPPING ZONE General Gaps Safe distances

68/120

APPENDIX A Clause

60601-1:2005 Topic

6.1

6.2 Risk Control Option Analysis

6.3 Implementation of risk control measures

6.4 Residual risk evaluation

6.5 Risk/Benefit Analysis

Risk Reduction 9.2.2.4 GUARDS and protective measures 9.2.2.4.1 Access to TRAPPING ZONES 9.2.2.4.2 FIXED GUARDS

9.2.2.4.3 Movable GUARDS

9.2.2.4.4 Protective measures

9.2.2.5 Continuous activation

9.2.2.6 Speed of movement(s) 9.2.3 Other HAZARDS associated with moving parts 9.2.3.1 Unintended movement 9.2.3.2 Overtravel 9.2.4 Emergency stopping devices 9.2.5 Release of PATIENT 9.3 9.4 9.4.1 9.4.2 9.4.2.1 9.4.2.2 9.4.2.3 9.4.2.4 HAZARD associated with surfaces, corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels

9.4.2.4.1 General 9.4.2.4.2 Force for propulsion 9.4.2.4.3 Movement over a threshold

69/120

4 Residual risk evaluation 6.5 Expelled parts HAZARD 9.5 Pressure vessels 9.1 Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General 70/120 .6.2.2 Infrasound and ultrasound energy 9.8.4 Grips and other handling devices 9.6.7.1 Audible acoustic energy 9.1 Protective means 9.5 Risk/Benefit Analysis Risk Reduction Instability from unwanted lateral movement (including 9.7 9.2 Pneumatic and hydraulic parts 9.6.3 Maximum pressure 9.6.7.1 6.8 9.7 hydraulic pressure 9.7.4.6 vibration 9.5.6.7.6 Pressure-control device 9.2 Instability excluding transport 9.7.7.4.7.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.4 Pressure rating of ME EQUIPMENT parts 9.1 Instability in transport 9.2 Acoustic energy 9.2.4.7.8 9.3.2 Cathode ray tubes Acoustic energy (including infra.3.and ultrasound) and 9.4.5.1 General 9.3 Implementation of risk control measures 6.3 sliding) 9.2 Risk Control Option Analysis 6.APPENDIX A Clause 60601-1:2005 Topic 6.1 General 9.

5 Other visible electromagnetic radiation 10.2 Risk Control Option Analysis 6.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.3 suspension systems 9.3. gamma.3 Implementation of risk control measures 6.4 Lasers and light emitting diodes (LEDs) 10.4.3 activation 9.8.1.8.8.1.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.APPENDIX A Clause 60601-1:2005 Topic 6.2 Static forces due to loading from persons 9.4.8.6 Infrared radiation 71/120 .2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.3.1 General 9.1 6.2 radiation 10. neutron and other particle 10.8.5 Risk/Benefit Analysis Risk Reduction 9.1 General Use after activation of a MECHANICAL PROTECTIVE 9.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.8.2 therapeutic X-radiation Alpha.8.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.4 Residual risk evaluation 6.3 Dynamic forces due to loading from persons 9.8.3 Microwave radiation 10.3.8. beta.4.

2 APPLIED PARTS not intended to supply heat to a PATIENT 11.1.1 Table 24 Skin contact with AP 11.2.2 with OXYGEN RICH ENVIRONMENTS 72/120 .2 Risk Control Option Analysis 6.1.1 Excessive temperatures in ME EQUIPMENT 11.1.1 Table 23 Parts likely to be touched 11.1 6.3 Implementation of risk control measures 6.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.3 Measurements 11.APPENDIX A Clause 60601-1:2005 Topic 6.1.1 APPLIED PARTS intended to supply heat to a PATIENT 11.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.1.4 Residual risk evaluation 6.2.2 Temperature of APPLIED PARTS 11.1.1.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.4 GUARDS 11.2.5 Risk/Benefit Analysis Risk Reduction 10.

4 11.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents 11.4 Leakage Ingress of water or particulate matter into ME 11. leakage.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS 73/120 .2.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11.6 SYSTEMS 11.5 Risk/Benefit Analysis Risk Reduction 11.6.6 EQUIPMENT 11. ingress of water or particulate matter.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11. spillage.3 11.6.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2 Risk Control Option Analysis 6.1 6.2.3 11.4 Residual risk evaluation 6.3 Implementation of risk control measures 6. cleaning.APPENDIX A Clause 60601-1:2005 Topic 6.6.2.6.6.2 Overflow in ME EQUIPMENT 11.2.8 Compatibility with substances used with the ME EQUIPMENT 11.2.6. disinfection.6.2. sterilization and compatibility with substances used with the ME 11.1 General 11.1 RISK of fire in an OXYGEN RICH ENVIRONMENT External exhaust outlets for OXYGEN RICH 11.5 Overflow.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.6.2.

2 13.4 13.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions.2 Diagnostic X-ray equipment 12.1.1.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.5.6 13 13.1 Accuracy of controls and instruments 12.APPENDIX A Clause 60601-1:2005 Topic 6.3 13.4.1 13.4.4.1 Limits 12.3 Alarm systems 12.3 Implementation of risk control measures 6.2 USABILITY 12.4 Incorrect output 12. deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS 74/120 .1 13.5 Risk/Benefit Analysis Risk Reduction Interruption of the power supply / SUPPLY MAINS to ME 11.5 Diagnostic or therapeutic radiation 12.4.4.1.4.5.4.4 Protection against hazardous output 12.4 Residual risk evaluation 6.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 6.5.1.4.5.4.1 Intentional exceeding of safety limits 12.3 Accidental selection of excessive output values 12.2 Risk Control Option Analysis 6.4 therapeutic radiation 12.4.2 Indication of parameters relevant to safety 12.

9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.3 14.2.4 14.8 Architecture 75/120 .4 13.4 Residual risk evaluation 6.13 Overload 13.12 HAZARD 13.2.1 6.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.2.13.7 Requirement specification 14.2 13.2.2.2.13.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.2.3 13.2.7 Impairment of cooling that could result in a HAZARD 13.2.8 Locking of moving parts 13.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.2.13.1 General 14.3 Implementation of risk control measures 6.1 Identification of known and foreseeable HAZARDS 14.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS 14.13.2 RISK CONTROL 14.2 Risk Control Option Analysis 6.2.2.1 13.2.2.2 Documentation 14.6 Leakage of liquid 13.6.6.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices 13.2.APPENDIX A Clause 60601-1:2005 Topic 6.2.2 ME EQUIPMENT with heating elements 13.5 14.1 General overload test conditions 13.5 Risk/Benefit Analysis Risk Reduction 13.4 OPERATION 14 Programmable electrical medical systems 14.2.

3.4 Residual risk evaluation 6.1 Construction of connectors 15.4.3 Impact test 15.2 Serviceability 15.1 HAND-HELD ME EQUIPMENT 15.4 ME EQUIPMENT components and general assembly 15.3.2 Push test 15.7 Environmental influences 15.3.3 Implementation of risk control measures 6.10' VERIFICATION 14.1 General 15.2 PORTABLE ME EQUIPMENT 15.3.9 Design and implementation 14.3.1 6.3.5 Rough handling test 15.4.4.4 Drop test 15.4.3.5 Risk/Benefit Analysis Risk Reduction 14.2 Temperature and overload control devices 76/120 .6 Mould stress relief test 15.3 Mechanical strength 15.APPENDIX A Clause 60601-1:2005 Topic 6.11 PEMS VALIDATION 14.2 Risk Control Option Analysis 6.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.3.3.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.1 EQUIPMENT 15.

3.4.2 Risk Control Option Analysis 6.4.4.4.4.6.4.7 devices (see also 8.7.6.2 Accidental operation of ME EQUIPMENT 15.8 Internal wiring of ME EQUIPMENT 15.4.4.3 Batteries 15.2.4.4 Residual risk evaluation 6.3 Entry of liquids 15.3.4.10.4.1 Housing 15.4. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing.4.APPENDIX A Clause 60601-1:2005 Topic 6.4) 15.4 Lithium batteries 15.2 Connection 15.3.3 Protection against overcharging 15.5 Excessive current and voltage protection 15.2.4.4.1 Application 15.1 6.5 Risk/Benefit Analysis Risk Reduction 15.7.5 15.6 15.2 Temperature settings 15.4.4.4.1 15.2 15.4.9 Oil containers 77/120 .7.1 Mechanical strength 15.3 Implementation of risk control measures 6.3.3.

3 15.6.1.9.1 16.6.4.5 Risk/Benefit Analysis Risk Reduction MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.2 16.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.3 Implementation of risk control measures 6.1 16.6.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.2 Risk Control Option Analysis 6.APPENDIX A Clause 60601-1:2005 Topic 6.9.2 16.2 15.6.1 16.3 16.4 16.5.5 16.1.2 16.1 15.8 16.1 16.5.5.2 15.9.4 Residual risk evaluation 6.1.2.4 16. components and layout MULTIPLE SOCKET-OUTLET 16.5 15.5 Medical electrical systems 15.4.2 16.3 16 16.1 6.6.9.3 Protection of conductors Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 78/120 .6.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.7 16.6 16.5.5.3 16.9.2.5.9 16.2.1 15.

1.5.2.1.4 ANAESTHETIC MIXTURE WITH AIR G.3 G.4.2. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.1 G.3 G. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT.1 Introduction Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.2 G.3 G.2.3 Implementation of risk control measures 6.4.2.5 G.3.1.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking.2.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.4 G.5.4. parts and components thereof General Power supply G.4.6 G.APPENDIX A Clause 60601-1:2005 Topic 6.1 G.5 Risk/Benefit Analysis Risk Reduction Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.4 Residual risk evaluation 6.3.2 G.1 G.1 G.1 6.5 G.6.3.2 Risk Control Option Analysis 6.3.3 G.1 G.2 G.5.6.5 G.3 G.5.5.2 G.4 G.3.4 G.1 G.5 G.2 79/120 .2 G.4 G.

5 Risk/Benefit Analysis Risk Reduction G.3 Temperatures and low-energy circuits G.6.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required 80/120 .6.2 Risk Control Option Analysis 6.1 6.4 Residual risk evaluation 6.4 Heating elements G.APPENDIX A Clause 60601-1:2005 Topic 6.3 Implementation of risk control measures 6.

1 Source of power for ME EQUIPMENT 4.9. humidity.1 5.9.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.1 Test finger 5.9 CHARACTERISTICS in ME EQUIPMENT 4. type of current.3 ESSENTIAL PERFORMANCE 4.11 5 5.9 PARTS 5.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.9.5 frequency 5.2 ACCESSIBLE PARTS 5.4 EXPECTED SERVICE LIFE 4.10.2 Test hook 5. 5.2.9.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4.4 Other conditions Supply voltages.9.1 APPLIED PARTS 5.2.10.6 6.2 ME SYSTEMS 4.6 Repairs and modifications 5.3 Actuating mechanisms 81/120 . nature of supply.10' Power supply 4.3 Ambient temperature.6 PATIENT 4.APPENDIX A Clause 60601-1:2005 Topic 6.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.7 Humidity preconditioning treatment 5.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.2 4.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples 5.2. atmospheric pressure 5.

14 7.4 6.2 7.2 Identification 7.2.12 7.3 Consult ACCOMPANYING DOCUMENTS 7.2.2.5 6.APPENDIX A Clause 60601-1:2005 Topic 6.1.2.8.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 6 Classification 6.9 7.15 7.2.2.2.7 7.1 7.4 Method(s) of sterilization 6.6 7 7.8.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable 7.2.2 Protection against electric shock Protection against harmful ingress of water or 6.16 82/120 . marking and documents General USABILITY of the identification.10 7.1 General 6.1.6 7.2.5 7.8 7. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.6 6.11 7.2.1 7.2.2 7.2.2.2.3 7.13 7.1.1 7.2 7.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification.3 particulate matter 6.2.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability 7.2.2.2.

4.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 7.7 7.2.5 PROTECTIVE EARTH TERMINALS 7.4 C.19 7.3 EQUIPMENT parts (see also Table C.2 HIGH VOLTAGE parts 7.3 7.2.APPENDIX A Clause 60601-1:2005 Topic 6.3.2 7.3.1 7.3.3.4 7.6 6.18 7.6.7.4 RELEASES 7.2 7.8 7.4.2.4.7 Supply terminals 7.6 FUNCTIONAL EARTH TERMINALS 7.3 Units of measure 7.6.3.3.3 7.1 Heating elements or lampholders 7.3 Batteries Fuses.7.2 Control devices 7.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.2. THERMAL CUT-OUTS and OVER-CURRENT 7.1 Power switches 7.5 7.1 7.8.3) 7.2) 7.7.17 7.6 7.3.3.5 7.6.7.7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights 83/120 .8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.

2.15 7.9.3.9. used 7. etc.2.2 other parts 7.9.2.9.2.1 7.10 7.4 Mains isolation Protection against electrical HAZARDS from ME 8 EQUIPMENT 8.9 7.9.5 7.9 ACCOMPANYING DOCUMENTS General (see also Table C.1 Connection to a separate power source 84/120 .2 Colours of controls 7.7 7.1 Environmental protection Reference to the technical description Technical description (see also Table C.8 7.9. component part lists.12 7.9.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 7.2 7.9.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.APPENDIX A Clause 60601-1:2005 Topic 6.6) General Replacement of fuses.2.9.8. supplementary equipment.3.2.2.2.3 Circuit diagrams.2.1 Fundamental rule of protection against electric shock 8.9.6 6.9.2.9.2.9.9.2.9.9.2.9.1 7.2. POWER SUPPLY CORDS and 7.3 power supply 7.2.2 7. 7.9.3 7.4 Electrical power source ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.2 Requirements related to power sources 8.2.13 7.14 material 7.9.4) Instructions for use (see also Table C.9.3.9. disinfection and sterilization Maintenance ACCESSORIES.9.3.11 7.9.2.16 7.6 7.

2 TYPE B APPLIED PARTS 8. power source 8.5.2.1.1 8.3 8.4.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.5.c.4.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 8.5.4.2 Energy reduction test 85/120 .1.1 Defibrillation protection 8.5.1.3 Classification of APPLIED PARTS 8.5.2.5.5.2.5.5.4 Internal capacitive circuits 8.6 6.5.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8. current or energy 8.1 MEANS OF PROTECTION (MOP) 8.4.1 PATIENT CONNECTIONS intended to deliver current 8.3 source by a plug 8.2 8.5.2.5 Separation of parts 8.1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS 8.4 WORKING VOLTAGE 8.2 Connection to an external d.4 Limitation of voltage.2 8.3 PATIENT leads 8.5.5.APPENDIX A Clause 60601-1:2005 Topic 6.5.3 MAXIMUM MAINS VOLTAGE 8.5.

2 SINGLE FAULT CONDITIONS 8.7.6.7.3 Dielectric strength 8.8 Measurement of the PATIENT AUXILIARY CURRENT 8.7. functional earthing and potential 8.7.7 Measurement of the PATIENT LEAKAGE CURRENT 8.3 Allowable values 8.8.6 Measurement of the TOUCH CURRENT 8.7 CURRENTS 8.7.4.7.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control Protective earthing.3 Connection to the measuring supply circuit 8.4.6.4 Insulation other than wire insulation 8.1 General requirements 8.4 Measurements 8.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.1 Applicability of requirements 8.4 Measuring device (MD) 8.8.1 General 8.4.6 equalization of ME Equipment 8.5 Measurement of the EARTH LEAKAGE CURRENT 8.2 material 8.4.4.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.6 6.1 Mechanical strength and resistance to heat 86/120 .4.6.4 8.8.7.7.1 General Distance through solid insulation or use of thin sheet 8.5 8.4.8 FUNCTIONAL EARTH TERMINAL 8.2 PROTECTIVE EARTH TERMINAL 8.4.2 Measuring supply circuits 8.6.8.7 POTENTIAL EQUALIZATION CONDUCTOR 8.6.7.7.3 8.6.APPENDIX A Clause 60601-1:2005 Topic 6.8.7.4.8 Insulation 8.7.6.6.6.7.4.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.

c.1.APPENDIX A Clause 60601-1:2005 Topic 6.9. Minimum CREEPAGE DISTANCES for two MEANS OF 8.15 DEFIBRILLATION-PROOF APPLIED 8.9.1.1.4.2 8.4 CLEARANCES 8.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.3.1.1.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass.9.3 8.1 8.8.1.9.3 Spaces filled by insulating compound 8.9.9.6 6.9.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 8.9.1.1.10.2 conductive parts Insulating compound forming a cemented joint with 8.9.1.9.3 Connections between different parts of ME EQUIPMENT 87/120 .7 8.2 Fixing of wiring 8.10 8.9.11 8.3.3.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8.5 8.10' Components and wiring 8.3.8 8.3 other insulating parts 8.9.2 8.9.9.9.1 General Insulating compound forming solid insulation between 8.9.1.9.1.1 8.1.9.9.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.1.10.9.1.10.9 8.1 Fixing of components 8.9.1.6 8.9 8.2 Application 8.9. mica.4 8.9. ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS 8.

2.10.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts 9.2 8.6 9 9.3.11.2.11.7 8. components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection 8.2 Connection cords 8.3 8.2.10.2 9.3 TRAPPING ZONE General Gaps Safe distances 88/120 .1 General 9.6 8.6 8.3.APPENDIX A Clause 60601-1:2005 Topic 6.11.1 8.11.4.10.11.11 8.3 8.11.11.4 8.4.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS.3.10.1 Limitation of operating voltages 8.3.1 9.3.1 9.2 8.4.11.2.11.2 8.2.11.6 6.4.11.11.4.10.2.11.4 8.5 Mechanical protection of wiring 8.4.1 8.11.2 9.4 8.10.11 8.5 8.5 Mains fuses and OVER-CURRENT RELEASES 8.3 8.11.4 foot-operated control devices 8.2.2.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control Cord-connected HAND-HELD parts and cord-connected 8.3.4.11.

4.6 Speed of movement(s) 9.2.2.4.1 Unintended movement 9.2.1 General 9.2.1 Access to TRAPPING ZONES 9.2 Force for propulsion 9.2.2.4.4.3.4.2 9.4.2.2.2.2.4 HAZARD associated with surfaces.4. corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels 9.2.2.4.2 Overtravel 9.2.3 Movable GUARDS 9.2.2.4.4 GUARDS and protective measures 9.4.2.1 9.2.2.3 9.4 9.3 Movement over a threshold 89/120 .4.2.3 Other HAZARDS associated with moving parts 9.2.2.4.2.5 Continuous activation 9.4 Protective measures 9.APPENDIX A Clause 60601-1:2005 Topic 6.5 Release of PATIENT 9.4.3 9.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 9.2 9.2.4 Emergency stopping devices 9.2.2 FIXED GUARDS 9.1 9.4.4.2.3.6 6.2.4.

2 Acoustic energy 9.7.3.4.7.4.7 hydraulic pressure 9.4 Grips and other handling devices 9.7.6 Pressure-control device 9.6.1 General 9.6.1 Instability in transport 9.1 Protective means 9.8.5 Expelled parts HAZARD 9.7.2 Infrasound and ultrasound energy 9.8 9.6 6.4 Pressure rating of ME EQUIPMENT parts 9.3.7.7.6.4.5.2 Instability excluding transport 9.and ultrasound) and 9.7 9.7.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.APPENDIX A Clause 60601-1:2005 Topic 6.8 9.4.2.7.5 Pressure vessels 9.5.6 vibration 9.1 Audible acoustic energy 9.1 Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General 90/120 .2 Pneumatic and hydraulic parts 9.2.1 General 9.6.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control Instability from unwanted lateral movement (including 9.6.3 Maximum pressure 9.3 sliding) 9.2 Cathode ray tubes Acoustic energy (including infra.

4 Lasers and light emitting diodes (LEDs) 10.5 Other visible electromagnetic radiation 10.8.2 radiation 10.6 Infrared radiation 91/120 .1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.8.8. neutron and other particle 10.4.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.1.3 Dynamic forces due to loading from persons 9.1.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.1 General 9.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.8.3.2 therapeutic X-radiation Alpha.3 Microwave radiation 10. beta.4.8.3.8. gamma.8.8.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.APPENDIX A Clause 60601-1:2005 Topic 6.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 9.4.3 suspension systems 9.6 6.3 activation 9.2 Static forces due to loading from persons 9.3.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.8.1 General Use after activation of a MECHANICAL PROTECTIVE 9.

1.6 6.4 GUARDS 11.2.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 10.2.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.1.2 with OXYGEN RICH ENVIRONMENTS 92/120 .1.1.1.2 APPLIED PARTS not intended to supply heat to a PATIENT 11.2 Temperature of APPLIED PARTS 11.1.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.2.3 Measurements 11.1 Excessive temperatures in ME EQUIPMENT 11.1 APPLIED PARTS intended to supply heat to a PATIENT 11.1 Table 23 Parts likely to be touched 11.1.APPENDIX A Clause 60601-1:2005 Topic 6.1 Table 24 Skin contact with AP 11.

APPENDIX A Clause

60601-1:2005 Topic

6.6

6.7

7 Residual Risk Evaluation

8 Risk Management Report

9 Production and Post Production Information

Risk arising from risk Completeness of Risk control measures Control

11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT

External exhaust outlets for OXYGEN RICH 11.2.2.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.2.2.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT and ME SYSTEMS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents

11.2.3 11.3 11.4 11.5

Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME 11.6 EQUIPMENT 11.6.1 General

11.6.2 Overflow in ME EQUIPMENT 11.6.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.6.4 Leakage Ingress of water or particulate matter into ME 11.6.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11.6.6 SYSTEMS 11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11.6.8 Compatibility with substances used with the ME EQUIPMENT

11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS

93/120

APPENDIX A Clause

60601-1:2005 Topic

6.6

6.7

7 Residual Risk Evaluation

8 Risk Management Report

9 Production and Post Production Information

Risk arising from risk Completeness of Risk control measures Control Interruption of the power supply / SUPPLY MAINS to ME 11.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.1 Accuracy of controls and instruments 12.2 USABILITY 12.3 Alarm systems 12.4 Protection against hazardous output

12.4.1 Intentional exceeding of safety limits

12.4.2 Indication of parameters relevant to safety

12.4.3 Accidental selection of excessive output values 12.4.4 Incorrect output 12.4.5 Diagnostic or therapeutic radiation 12.4.5.1 Limits 12.4.5.2 Diagnostic X-ray equipment 12.4.5.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.4.5.4 therapeutic radiation 12.4.6 13 13.1 13.1.1 13.1.2 13.1.3 13.1.4 13.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions, deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS

94/120

APPENDIX A Clause

60601-1:2005 Topic

6.6

6.7

7 Residual Risk Evaluation

8 Risk Management Report

9 Production and Post Production Information

Risk arising from risk Completeness of Risk control measures Control 13.2.1 13.2.2 13.2.3 13.2.4 13.2.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices

13.2.6 Leakage of liquid 13.2.7 Impairment of cooling that could result in a HAZARD 13.2.8 Locking of moving parts 13.2.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.2.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.2.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.2.12 HAZARD 13.2.13 Overload 13.2.13.1 General overload test conditions 13.2.13.2 ME EQUIPMENT with heating elements 13.2.13.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.2.13.4 OPERATION 14 Programmable electrical medical systems

14.1 General 14.2 Documentation 14.3 14.4 14.5 14.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS

14.6.1 Identification of known and foreseeable HAZARDS 14.6.2 RISK CONTROL 14.7 Requirement specification 14.8 Architecture

95/120

2 Temperature and overload control devices 96/120 .3 Impact test 15.3.6 Mould stress relief test 15.1 General 15.3.9 Design and implementation 14.4.3.1 Construction of connectors 15.APPENDIX A Clause 60601-1:2005 Topic 6.3.3.2 PORTABLE ME EQUIPMENT 15.6 6.10' VERIFICATION 14.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 14.3.7 Environmental influences 15.2 Push test 15.3.3 Mechanical strength 15.4.4 Drop test 15.1 EQUIPMENT 15.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15.2 Serviceability 15.11 PEMS VALIDATION 14.4.4.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.3.5 Rough handling test 15.1 HAND-HELD ME EQUIPMENT 15.4 ME EQUIPMENT components and general assembly 15.3.

3.4.2.4.10.3.4.2 Temperature settings 15.3 Protection against overcharging 15.4.3.4.4.4) 15.2 Connection 15.1 Mechanical strength 15.4.8 Internal wiring of ME EQUIPMENT 15.6.3 Batteries 15.4.7.4.4.9 Oil containers 97/120 .2.4.4.4.4.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control 15.2 15.5 15.4.4.7.1 Housing 15.1 Application 15.6 6.4.2 Accidental operation of ME EQUIPMENT 15.6 15.APPENDIX A Clause 60601-1:2005 Topic 6.3.7 devices (see also 8.3 Entry of liquids 15.5 Excessive current and voltage protection 15.4 Lithium batteries 15.7. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing.4.1 15.3.6.4.

1 16.6.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.6 6.5.9.3 16.2.2 15.1 16.5 Medical electrical systems 15.5.5.9.1 15.4 16.1.3 16. components and layout MULTIPLE SOCKET-OUTLET 16.9 16.5.6 16.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.3 16 16.8 16.5 16.2 16.9.2.6.2 16.9.3 15.2 16.1.2.2 16.4.1 16.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.6.6.6.APPENDIX A Clause 60601-1:2005 Topic 6.2 15.9.4.1.3 Protection of conductors Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 98/120 .6.5 15.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.5.4 16.1 15.5.7 16.1 16.

5 G.3 G.3.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.5.6 6.5 G.3. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.1.3.3 G.2 G.4 G.4.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.3 G.3.5 G.2 G.4 G. parts and components thereof General Power supply G.1.5.1 G.3.1 G.2.3 G.4 ANAESTHETIC MIXTURE WITH AIR G.5.2 99/120 .1 G.4 G.4 G.1 G.5.2 G.2.2 G.6.1 G.5 G.APPENDIX A Clause 60601-1:2005 Topic 6.6. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT.2.2.4.4.1.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking.6 G.1 G.4.3 G.2 G.5.2.1 Introduction Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.

6 6.6.7 7 Residual Risk Evaluation 8 Risk Management Report 9 Production and Post Production Information Risk arising from risk Completeness of Risk control measures Control G.APPENDIX A Clause 60601-1:2005 Topic 6.4 Heating elements G.6.7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required 100/120 .3 Temperatures and low-energy circuits G.

5 frequency 5.10' Power supply 4.4 Other conditions Supply voltages. Risk management is used to facilitate the considerations of single fault conditions to be applied.3 ESSENTIAL PERFORMANCE 4. Impacts some of the verification testing the manufacturer must conduct. 5.9.10. Component rating exceptions may be made by the use of risk management.9. type of current. Affects the basic safety verification of parts that can contact the patient. atmospheric pressure 5.1 APPLIED PARTS 5. nature of supply.9.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.8 Sequence of tests Determination of APPLIED PARTS and ACCESSIBLE 5.9 CHARACTERISTICS in ME EQUIPMENT 4.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS Power input General requirements for testing TYPE TESTS Number of samples All parts b) a) Provides verification testing input.2.3 Actuating mechanisms a) b).9.1 Test finger 5.7 Humidity preconditioning treatment 5. humidity.11 5 5.2. Affects the compliance criteria for specific tests. d) Provides verification testing input.9.1 5. 5.6 Repairs and modifications 5. 101/120 .6 PATIENT 4.7 SINGLE FAULT CONDITION for ME EQUIPMENT 4. Determines accessibility of accuating mechanisms.2 ACCESSIBLE PARTS 5.2. management to risk management Comments 4 General requirements Conditions for application to ME EQUIPMENT or ME 4.1 Source of power for ME EQUIPMENT 4. Risk management may be used to determine the need for the use of High-Integrity components.5 Equivalent safety for ME EQUIPMENT or ME SYSTEMS ME EQUIPMENT or ME SYSTEM parts that contact the 4. Provides verification testing input. 4.4 EXPECTED SERVICE LIFE Requires a risk management process in accordance with ISO 14971 and that the risks from the device are managed using the manufacturer's process.2 4.3 Ambient temperature. c).How risk management affects the requirement(s). Provides an alternate compliance means of compliance when an equivalent or lower residual level of risk results.10.2 Test hook 5.8 Components of ME EQUIPMENT Use of COMPONENTS WITH HIGH-INTEGRITY 4.2 ME SYSTEMS 4.1 SYSTEMS RISK MANAGEMENT PROCESS for ME EQUIPMENT or 4.9 PARTS 5.

2 7.11 7.2 7.1) Minimum requirements for marking on ME EQUIPMENT and on interchangeable The Usability Engineering Process includes the risk of poor usability.1 7.6 7.1 7.13 7.2.2.4 Method(s) of sterilization 6.1 Suitability for use in an OXYGEN RICH ENVIRONMENT Mode of operation Identification. 7.2.5 6.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.1.4 ACCESSORIES ME EQUIPMENT intended to receive power from other equipment Connection to the SUPPLY MAINS Electrical input power from the SUPPLY MAINS Output connectors Mains power output Other power sources IP classification APPLIED PARTS Mode of operation Fuses Physiological effects (safety signs and warning statements) HIGH VOLTAGE TERMINAL DEVICES Cooling conditions Mechanical stability Risk management may be used to demonstrate that marking is not necessary. marking and documents Legibility of markings Durability of markings Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts (see also Table C.5 7. 7. management to risk management Comments 6 Classification 6.2.3 particulate matter 6.4 6.9 7. marking and documents General USABILITY of the identification.1.2.6 7 7.3 Consult ACCOMPANYING DOCUMENTS 7.1 General 6.2 7.14 7.12 The risk management file may indicate the need for a specific power supply and require marking for risk control.8.2.2 Protection against electric shock Protection against harmful ingress of water or 6.1 7.2. 102/120 .8.1.3 7.2.How risk management affects the requirement(s).2.2.15 7.16 The RMF may have considered physiological effects in the risk assessment and may have indicated the need for marking as a risk control measure.2.2.2.8 7.2.2. 7.2.2 Identification 7.2.7 7.2.10 7.

4 RELEASES 7.3 EQUIPMENT parts (see also Table C.17 7. 7.2 7.7 7.5 PROTECTIVE EARTH TERMINALS 7.6.3.3.2.3.18 7.7.3) 7.2.6.3 7.2 HIGH VOLTAGE parts 7. Risk assessment may include risk control measures requiring the use of safety sign(s) to convey a warning.8.5 7.5 7.19 7.1 Power switches 7.2) 7.3.8 7.1 7.1 7. THERMAL CUT-OUTS and OVER-CURRENT 7. The risk management file may indicate the need for control marking based on risk assessment.4.4 C.7.3.3.How risk management affects the requirement(s).7.7.3 7.4.3 Units of measure The risk assessment may include the need for adequately training personnel to change lithium batteries or fuel cells and provide marking and IFU requirements as risk control measures.3.6.6 7. d) 103/120 . c).2.4 7.2 Control devices 7.8 Temperature of supply terminals Marking of controls and instruments (see also Table 7.3.20 Protective packaging External pressure source FUNCTIONAL EARTH TERMINALS Removable protective means Marking on the inside of ME EQUIPMENT or ME 7.1 Safety signs Symbols Explanation of symbols Symbols from Annex D Symbols for controls and performance Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR PROTECTIVE EARTH CONNECTIONS Green and yellow insulation Neutral conductor POWER SUPPLY CORD conductors Indicator lights and controls Colours of indicator lights b) a).6 FUNCTIONAL EARTH TERMINALS 7. management to risk management Comments The risk assessment may include the need for protective packaging and identify marking as a risk control measure.2.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General. 7.7 Supply terminals 7.1 Heating elements or lampholders 7.4. prohibition or mandatory action. The risk assessment may identify any hazardous situations from supply terminal connections.3 Batteries Fuses.7.2 7.

2.1 7.How risk management affects the requirement(s).2.9. component part lists.16 7.9.2.9.9.11 7. disinfection and sterilization Maintenance ACCESSORIES. used 7.3 power supply 7.2.7 7.6 7.9. 8.2.3.9.9 7.9.1 7.2.3.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.5 7. General (see also Table C.1 Connection to a separate power source Provides verification tests input for SFC's when applicable.2.9.4 8 Risk assessment may include the need for risk control measures with regard to replacement of components and associated hazards.9.2. Risk assessment may indicate the need for risk control measures for providing IFU advice for patient or operator protection from materials or ingredients.13 7.2.2 7.9.9. residues and of the MEE and accessories at the end of their useful life and advice for minimizing these risks.2. supplementary equipment.8.3 7.9.1 Environmental protection Reference to the technical description Technical description (see also Table C.9.2. management to risk management Comments 7.14 material 7.2.3. 104/120 .2.2.9.4 Electrical power source Inspect IFU accordingly. Mains isolation Protection against electrical HAZARDS from ME EQUIPMENT b) a) Risk assessment may indicate the need for risk control measures for the disposal of waste products.9.2 Requirements related to power sources 8.2 7.12 7. etc.9.9.6) General Replacement of fuses. Risk assessment may indicate the need for risk control measures for removing batteries and for loss of power.9.3.10 7.2 Colours of controls 7.1 Fundamental rule of protection against electric shock 8.9.9.15 7. ME EQUIPMENT description Installation Isolation from the SUPPLY MAINS Start-up PROCEDURE Operating instructions Messages Shutdown PROCEDURE Cleaning.2.2.9. 7.5) General Warning and safety notices ME EQUIPMENT specified for connection to a separate 7.2. POWER SUPPLY CORDS and other parts Circuit diagrams.2 7.9.4) Instructions for use (see also Table C.9 ACCOMPANYING DOCUMENTS Risk management provides consideration for which information needs to be provided as hard copy or as marking on the device.9.8 7.3 7.

2 TYPE B APPLIED PARTS Risk management may be used to exempt the one means of patient protection separation requirement between unearthed Type B Applied Parts and unearhted conductive accessible parts.5 Separation of parts 8. current or energy 8.5.2 Connection to an external d. power source Risk assessment may identify the need for risk control measures for parts (not being applied parts) that can come into contact with the patient and at what level these parts require protection means.1 8.5.5.1. the risk assessment and any risk control measures includes consideration for shock hazards because of the lack of separation.1.5.1 MEANS OF PROTECTION (MOP) c) a).3 source by a plug 8.2.4.2. 105/120 .1 Defibrillation protection 8. 8.4. 8.3 MAXIMUM MAINS VOLTAGE 8.4.5.5. management to risk management Comments 8. c) 8.5.2.How risk management affects the requirement(s).5. b).1 General MEANS OF PATIENT PROTECTION (MOPP) MEANS OF OPERATOR PROTECTION (MOOP) Separation of PATIENT CONNECTIONS F-TYPE APPLIED PARTS Risk assessment and any risk control measures for insulation coatings that provide a means for patient protection may be included in the risk management file.4.5.5. b) For the situation of an applied part with multiple functions where separate functions are not all defibrillator-proof.5.4 Internal capacitive circuits 8. 8.2 8.2 ACCESSIBLE PARTS including APPLIED PARTS ME EQUIPMENT intended to be connected to a power 8.2.3 PATIENT leads 8. e) Risk assessment may reveal that contacts of connectors or fuseholders or lampholders or parts inside an access cover do not require touch leakage current limitation because the probability of contact is low enough. 8.3 8. b).5.5.5.3 Classification of APPLIED PARTS 8.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.2 Energy reduction test a).1.2 8.5.1 PATIENT CONNECTIONS intended to deliver current d) a). d). Risk management may be used to provide exemption from testing with the straight unjointed test finger because unacceptable risk from contact with corners and edges will not occur.5 DEFIBRILLATION-PROOF APPLIED PARTS 8.4 WORKING VOLTAGE 8.4 Limitation of voltage.c.

2 Measuring supply circuits 8.4. 8.7. functional earthing and potential 8.2 PROTECTIVE EARTH TERMINAL The risk management file may include the identification of the need for moving parts to be protectively earthed and the connection reliability during the expected service life.6.8.7.7 POTENTIAL EQUALIZATION CONDUCTOR 8.4.8.9 CLASS II ME EQUIPMENT LEAKAGE CURRENTS and PATIENT AUXILIARY 8.4 Measurements 8.8.3 Allowable values 8.6.7.1 Applicability of requirements 8.7 CURRENTS 8.4 8.1 General requirements 8.5 Measurement of the EARTH LEAKAGE CURRENT 8.1 General Distance through solid insulation or use of thin sheet 8. 106/120 .6.How risk management affects the requirement(s).6 equalization of ME Equipment 8.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS 8.2 material 8.4 Measuring device (MD) 8.6.6.1 General 8.6.4.3 Dielectric strength 8.6 Measurement of the TOUCH CURRENT 8.7.4.4.7.5 8.8 Insulation 8.6.4.1 Mechanical strength and resistance to heat a) b) Risk assessment and any risk control measures for resistance to heat of insulation (other than wire insulation) is included in the risk management file.7.7.3 Connection to the measuring supply circuit 8.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General. management to risk management Comments Protective earthing.4.4.6.8 Measurement of the PATIENT AUXILIARY CURRENT 8.8.7 Measurement of the PATIENT LEAKAGE CURRENT 8. 8.8.7.4.7.6 Protective earthing of moving parts Impedance and current-carrying capability Surface coatings Plugs and sockets 8.8 FUNCTIONAL EARTH TERMINAL 8.3 8.7.6.7.4.2 SINGLE FAULT CONDITIONS 8.4 Insulation other than wire insulation The risk management file may include consideration for the accidental disconnection of the potential equalization conductor.7.7.

9.9.4 8.1 Fixing of components The need for securely mounting components is included in the risk management file.1.10 8.3.9.1.1 8.1.9.9.9.9.9.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.3 8.9.1. mica.9.2 8.1.9.2 conductive parts Insulating compound forming a cemented joint with 8.9.9.1.9.1.1.4.9.How risk management affects the requirement(s).1. ceramic and similar materials Minimum CREEPAGE DISTANCE ME EQUIPMENT RATED for high altitudes Interpolation Material groups classification Pollution degree classification Overvoltage category classification AIR CLEARANCE for MAINS PARTS SUPPLY MAINS overvoltage SECONDARY CIRCUITS 8.4 Thermal cycling Measurement of CREEPAGE DISTANCES AND AIR 8. management to risk management Comments 8.9.9.8.9 8.9.10.5 8.9.3 other insulating parts 8.15 DEFIBRILLATION-PROOF APPLIED 8.9.9 8.11 8.8 8. Minimum CREEPAGE DISTANCES for two MEANS OF 8. The need for securing conductors and connectors and not solder coating stranded conductors to prevent a hazardous situation from detachment is considered in the risk management file.c.12 Resistance to environmental stress CREEPAGE DISTANCES and AIR CLEARANCES Values General CREEPAGE DISTANCES and AIR CLEARANCES complying with IEC 60950-1 CREEPAGE DISTANCES across glass.7 8.1 8.3 Connections between different parts of ME EQUIPMENT 107/120 .1.9.1.10' Components and wiring 8.6 8.2 8.3.1.9.1. 8.2 Application 8.3.2 Fixing of wiring 8.1 General Insulating compound forming solid insulation between 8.9.3 Spaces filled by insulating compound 8.1.10.10.13 PEAK WORKING VOLTAGES above 1 400 V peak or d.3.4 CLEARANCES 8.1.14 OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for 8.

2.10.11. components and layout Isolation from the SUPPLY MAINS MULTIPLE SOCKET-OUTLETS POWER SUPPLY CORDS Application Types Cross-sectional area of POWER SUPPLY CORD conductors APPLIANCE COUPLERS Cord anchorage Cord guards MAINS TERMINAL DEVICES General requirements for MAINS TERMINAL DEVICES Arrangement of MAINS TERMINAL DEVICES Fixing of mains terminals Connections to mains terminals Accessibility of the connection 8.4.2 9.4.2. assembly or opering or closing access covers.4.10.11 8.2.3.2.2.10.3.3 TRAPPING ZONE General Gaps Safe distances Risk management is used to assess.11.11 8.6 8.3.5 Guiding rollers for insulated conductors Insulation of internal wiring MAINS PARTS.2.11. 8.6 9 9.1 Limitation of operating voltages 8.4. control and consider the residual risk associated with moving parts.11.2.11.1 8.2 8.10.4.3 8.3.1 General 9.10.4 8.11.11.11. wiring.2.5 Mechanical protection of wiring a).11.11. management to risk management Comments Cord-connected HAND-HELD parts and cord-connected 8.11.4.4 8.3.4 8.11.5 8.4.4 foot-operated control devices 8.2 8.2 8.5 Mains fuses and OVER-CURRENT RELEASES 8. 9.7 8. b) 8. the risk management file includes justification for the omission.2 Connection cords The risk management file risk assessment and risk control measures may include protection of cables.How risk management affects the requirement(s).11.2 Internal wiring of the MAINS PART Mechanical Hazards MECHANICAL HAZARDS of ME EQUIPMENT HAZARDS associated with moving parts If the manufacturer omits fuses or over-current releases.1 9.2 9. 108/120 .3.11.3 8.3 8.11. cord forms or components from damage by moving parts.1 8.10.1 9. friction at sharp corners or edges.11.6 8.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.

4.4 9.2. 9.3 Movable GUARDS The risk management file includes considerations movable guards that can be opened without the use of a tool.2 Overtravel 9.2.3.4 Protective measures 9.How risk management affects the requirement(s). g).3. corners and edges.4.2 to 9.2.5 Release of PATIENT 9. e) c).2.4.4.2.4.2. The risk management file includes considerations for protective measures providing protection from moving parts. 9.4.2.5 Continuous activation a). h).2.2.2.4. b). Inspect controls for unintended movement hazards. The risk management file includes considerations for overtravel and end stops or other stopping means. c) 9.2 9.2.3 9.2. corners and edges Instability HAZARDS General Instability – overbalance Instability in transport position Instability excluding transport Instability from horizontal and vertical forces Castors and wheels a).4.2. j). The risk management file includes considerations for the release of the patient.2. k) a).2.1 General 9. f). b) Equipment with castors or wheels may include a risk assessment and risk control measures for when the equipment is moved or parked.2.4 Emergency stopping devices 9.2.1 Unintended movement 9.3 Other HAZARDS associated with moving parts 9.2.3 Movement over a threshold For mobile equipment weighing over 45 kg. The risk management file includes considerations for continuous activation controls and the need for emergency stopping devices in regards to moving parts and trapping zones. the risk management file includes risk assessment and any risk control measures when passing over a 20 mm high 80 mm wide step. management to risk management Comments 9. d).1 9.1 9.2 FIXED GUARDS Risk management may be used for guards and protective measures. b). 109/120 .2.2 Force for propulsion 9.2.6 Speed of movement(s) 9.2.4.4 GUARDS and protective measures 9.1 Access to TRAPPING ZONES 9. The risk management file includes considerations for emergency stopping devices.4.4.4. 9.4.2.4. i).4.2.4. Follow the requirements given in clauses 9.4.4.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.2.4.3 9.2 9.4 HAZARD associated with surfaces. The risk management file includes considerations for hazards associated with surfaces. The risk management file includes consideration for the speed of moving parts and the overtravel after activation to stop movement.2.2.

APPENDIX A Clause

60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments

Instability from unwanted lateral movement (including 9.4.3 sliding) 9.4.3.1 Instability in transport 9.4.3.2 Instability excluding transport 9.4.4 Grips and other handling devices 9.5 Expelled parts HAZARD a), b), c), d) a), b) Instability in transport from unwanted lateral movement may be included in the risk management file. Instability excluding transport from unwanted lateral movement may be included in the risk management file.

9.5.1 Protective means 9.5.2 Cathode ray tubes Acoustic energy (including infra- and ultrasound) and 9.6 vibration

The risk management file includes an assessment and any risk control measures regarding the need for protective means from expelled parts.

9.6.1 General 9.6.2 Acoustic energy 9.6.2.1 Audible acoustic energy

Where applicable, the risk management file includes a risk assessment and any risk control measures for protection from acoustic energy and vibration.

9.6.2.2 Infrasound and ultrasound energy 9.6.3 Hand-transmitted vibration Pressure vessels and parts subject to pneumatic and 9.7 hydraulic pressure 9.7.1 General 9.7.2 Pneumatic and hydraulic parts 9.7.3 Maximum pressure

Where applicable, the risk management file includes a risk assessment and any risk control measures for protection from infrasound and ultrasound energy.

The risk management file includes considerations for parts subject to pneumatic or hydraulic pressure. Where applicable, the risk management file includes consideration for the necessary pressure rating of parts in both normal and single fault condition. Risk management may include an assessment for leakage from parts under pressure. Where applicable, the risk management file includes consideration for pressure control device performance and operation point. Where applicable, the risk management file includes consideration for pressure relief device operation discharge and characteristics identified herin.

9.7.4 Pressure rating of ME EQUIPMENT parts 9.7.5 Pressure vessels

9.7.6 Pressure-control device

9.7.7 9.7.8 9.8 9.8.1

Pressure-relief device RATED maximum supply pressure HAZARDS associated with support systems General

a), b), c), d), e), f), g), h)

Where applicable, the risk management file includes

110/120

APPENDIX A Clause

60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments

9.8.2 TENSILE SAFETY FACTOR Strength of PATIENT or OPERATOR support or 9.8.3 suspension systems

consideration for hazards associated with support systems.

9.8.3.1 General

Where applicable, the risk management file includes consideration for the strength of patient or operator support or suspension systems. Where applicable, the risk management file includes consideration for static forces due to loading from persons. The RMF may be helpful with determination of unacceptable risks caused by dynamic forces due to loading from persons.

9.8.3.2 Static forces due to loading from persons

a), b)

9.8.3.3 Dynamic forces due to loading from persons 9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES 9.8.4.1 General Use after activation of a MECHANICAL PROTECTIVE 9.8.4.2 DEVICE MECHANICAL PROTECTIVE DEVICE intended for single 9.8.4.3 activation b) a)

Where applicable, the risk management file includes consideration for mechanical protective devices.

Where applicable, the risk management file includes consideration for mechanical protective device(s) intended for single activation. Where applicable, the risk management file includes consideration for not requiring the use of a mechanical protective device(s).

9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES 10 Radiation Hazards 10.1 X-Radiation ME EQUIPMENT not intended to produce diagnostic or 10.1.1 therapeutic X-radiation ME EQUIPMENT Intended to produce diagnostic or 10.1.2 therapeutic X-radiation Alpha, beta, gamma, neutron and other particle 10.2 radiation 10.3 Microwave radiation 10.4 Lasers and light emitting diodes (LEDs)

Where applicable, the risk management file includes considerations for unintended X-radiation. Where applicable, the risk management file includes considerations for alpha, beta, gamma, neutron and other partical radiation. Where applicable, the risk management file includes considerations for microwave radiation.

10.5 Other visible electromagnetic radiation

Where applicable, the risk management file includes considerations for visible electromagnetic radiation other than that produced by lasers and light emitting diodes. Where applicable, the risk management file includes considerations for infrared radiation other than that produced by lasers and light emitting diodes.

10.6 Infrared radiation

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APPENDIX A Clause

60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General- How risk management affects the requirement(s). management to risk management Comments Where applicable, the risk management file includes considerations for ultraviolet radiation other than that produced by lasers and light emitting diodes.

10.7 Ultraviolet radiation 11 Temperature and Other Hazards 11.1 Excessive temperatures in ME EQUIPMENT

11.1.1 Table 23 Parts likely to be touched

Where applicable, the risk management file includes consideration for the temperature of parts likely to be touched by either unhealthy skin or surface area's greater than 10 % of the total body surface or greater than 10 % of the total head surface. Where applicable, the risk management file includes consideration for the temperature of applied parts for either unhealthy skin or surface area's greater than 10 % of the total body surface or greater than 10 % of the total head surface. Where applicable, the risk management file includes consideration for the temperature and clinical effects from applied parts intended to supply heat to a patient. Where applicable, the risk management file includes consideration for the clinical effects with respect to characteristics such as body surface, maturity of patients, medications being taken or surface pressure when applied part temperature exceed 41 ° C or are cooled below ambient temperature. The risk management file may include judgements that temperature measurement is not necessary or the use of the test corner is not necessary and the probability of occurrence of contact and of the duration of contact for parts likely to be touched and for applied parts. Any alternative test methods are justified in the risk management file.

11.1.1 Table 24 Skin contact with AP

11.1.2 Temperature of APPLIED PARTS 11.1.2.1 APPLIED PARTS intended to supply heat to a PATIENT

11.1.2.2

APPLIED PARTS not intended to supply heat to a PATIENT

11.1.3 Measurements

e) is 6.3 only 11.1.4 GUARDS 11.2 Fire prevention Strength and rigidity required to prevent fire in ME 11.2.1 EQUIPMENT ME EQUIPMENT and ME SYSTEMS used in conjunction 11.2.2 with OXYGEN RICH ENVIRONMENTS

a), b), c), d)

112/120

3 and ME SYSTEMS Constructional requirements for fire ENCLOSURES of 11.4 Leakage Ingress of water or particulate matter into ME 11.6.2. The risk management file is used to capture the results of multiple cleanings over the expected service life.2. duration of spill and location. volume.How risk management affects the requirement(s). b) The risk management file may be used to analyze risk for the construction of fire enclosures.6. leakage. The risk management file includes consideration for the possibility of fire and associated mitigations.4 with flammable anaesthetics ME EQUIPMENT and ME SYSTEMS intended for use in 11.7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS 113/120 . ingress of water or particulate matter. This is an input for test verifcation.5 EQUIPMENT and ME SYSTEMS Cleaning and disinfection of ME EQUIPMENT and ME 11. 11.2. spillage.2. Determination for the acceptable design configuration that provides an acceptable residual risk of fire in an oxygen rich environment.2 Overflow in ME EQUIPMENT 11. management to risk management Comments The risk management file may provide justification for deviations from worst-case limits (lower oxygen concentrations or less flammable fuel).2.3 ENVIRONMENTS SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS in conjunction with ME EQUIPMENT 11.2. where applicable.6.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.1 General a). b) External exhaust outlets for OXYGEN RICH 11. 11.2 ENVIRONMENT Electrical connections in OXYGEN RICH 11.6. The risk management file includes risk assessment and risk control measures for parts that are sterilized.6 SYSTEMS 11. cleaning.6. compatibility with substances. Risk management may be used for external exhaust outlets and electrical components location in an oxygen rich environment. 11.6. disinfection.6.2.6 EQUIPMENT 11.6.3 ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS intended for use 11. sterilization and compatibility with substances used with the ME 11. the risk management file includes consideration for the type of liquids.1 RISK of fire in an OXYGEN RICH ENVIRONMENT a). The risk management file includes.3 Spillage on ME EQUIPMENT and ME SYSTEM 11.8 Compatibility with substances used with the ME EQUIPMENT Risk management may include risk assessment and risk control measure for equipment which incorporates a liquid reservoir. Where applicable.5 conjunction with flammable agents Overflow.7 Sterilization of ME EQUIPMENT and ME SYSTEMS 11.

1 13.4.4.3 13.3 Alarm systems 12.1. Risk management is used to address the risk of accidental selection of excessive output values when equipment provides both low-intensity and high-intensity outputs.1 Accuracy of controls and instruments 12.4.5.1 Limits 12.1.6 13 13.4 Protection against hazardous output The risk management file includes a risk assessment associated with hazardous output from intentional exceeding of safety limits.3 Radiotherapy equipment Other ME EQUIPMENT producing diagnostic or 12.2 Diagnostic X-ray equipment 12.5 Diagnostic or therapeutic radiation 12. deformation of ENCLOSURE or exceeding maximum temperature Exceeding LEAKAGE CURRENT or voltage limits Specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS Risk management is used to address the risk associated with diagnostic X-rays.2 USABILITY 12.4.1 13. Risk management is used to address the risk associated with incorrect output.4 Incorrect output 12.4. The risk management file includes risk assessment and any risk control measures associated with the accuracy of controls.2 Diagnostic or therapeutic acoustic pressure Hazardous situations and fault conditions Specific Hazardous Situations General Emissions.1. 114/120 . Risk management is used to address the risk associated with diagnostic or therapeutic acoustic pressure.5.4.5.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General. The risk management file includes the need for alarm systems as a risk control measure and addresses any risk associated with the operation or failure of the alarm system.8 EQUIPMENT 12 Accuracy and hazardous outputs 12.4. 12.1 Intentional exceeding of safety limits 12.2 13. Risk management is used to address the risk associated with radiotherapy. The risk management file includes the need for the indication of parameters that are associated with hazardous output.4.2 Indication of parameters relevant to safety 12. Risk management is used to address the risk associated with diagnostic or therapeutic radiatio other than diagnostic X-ray and radiotherapy.5. Follow these requirements and those in IEC 60601-1-6.How risk management affects the requirement(s).4 therapeutic radiation 12. management to risk management Comments Interruption of the power supply / SUPPLY MAINS to ME 11.4.1.3 Accidental selection of excessive output values 12.4.4 13.

6 Leakage of liquid 13.2.1 Identification of known and foreseeable HAZARDS 14.3 13. management to risk management Comments 13.5 General Electrical SINGLE FAULT CONDITION Overheating of transformers in ME EQUIPMENT Failure of THERMOSTATS Failure of temperature limiting devices Risk management is used to determine the appropriate test conditions for leakage of liquids.13 Overload 13. 14.6.2.2.8 Locking of moving parts 13.4 14. Thr risk management file includes the documents required from clause 14 application.2.6 Risk MANAGEMENT plan PEMS DEVELOPMENT LIFE-CYCLE Problem resolution RISK MANAGEMENT PROCESS Risk management can be used to demonstrate that the failure of the PESS does not lead to an unacceptable risk.How risk management affects the requirement(s).1 General 14.2.3 ME EQUIPMENT with motors ME EQUIPMENT RATED for non-CONTINUOUS 13.1 General overload test conditions 13.6.13.2.2.2.2.5 14.10 EQUIPMENT Failures of components in ME EQUIPMENT used in 13.7 Requirement specification 14.2 RISK CONTROL 14.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.13.2.12 HAZARD 13.1 13.2. 115/120 .2.11 conjunction with OXYGEN RICH ENVIRONMENTS Failure of parts that might result in a MECHANICAL 13.4 OPERATION 14 Programmable electrical medical systems 14. Thr risk management plan includes PEMS Validation Plan.2 13.4 13.2.3 14.2.7 Impairment of cooling that could result in a HAZARD 13. Validated tools and procedures are selected and identified to implement each risk control measure.2.2 ME EQUIPMENT with heating elements 13.2 Documentation 14.9 Interruption and short circuiting of motor capacitors Additional test criteria for motor operated ME 13.2.13. 13.13.8 Architecture Risk Analysis includes hazards associated with PEMS hardware and software aspects including Network/Data Coupling.2.

3.12 Modification Connection of PEMS by NETWORK/DATA COUPLING to 14.4 ME EQUIPMENT components and general assembly 15. basic safety and essential performance.3.3.3 Impact test 15.1 EQUIPMENT Risk management addresses the risks associated with the arrangement of controls and indicators.4 Drop test 15. Risk management may be used to identify risks associated with hand-held equipment drops. replacement and maintenance. Risk management is used to identify risks associated with impacts. The risk management file includes all professional relationships of the membes of the PEMS development team and the design team and also a reference to the methods and results of the PEMS Validation.13 other equipment 15 Construction Arrangements of controls and indicators of ME 15. Risk management is used to identify risks associated with mobile equipment cuased by asending step. 116/120 .3.2 Serviceability 15.2 Push test 15.11 PEMS VALIDATION 14. Risk management may provide evidence of unaccepatable risk for inspection after mold stress relief testing. b) Risk management is used to address the risk of electrical. Verification of all functions that implement risk control measure.4.3.7 Environmental influences 15. pneumatic and gas connection terminals and connectors.1 Construction of connectors 15. management to risk management Comments 14.3 Mechanical strength 15.3.5 Rough handling test 15.3.2 Temperature and overload control devices a). hydraulic.1 HAND-HELD ME EQUIPMENT 15. 15.6 Mould stress relief test 15.9 Design and implementation 14.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.4.4.3.3.How risk management affects the requirement(s).10' VERIFICATION The risk management file includes descriptive data regarding the design environment.2 PORTABLE ME EQUIPMENT Risk management is used to identify risk associated with pushing. 15. Risk control measures may identify the need for parts to be accessible for inspection. 14. descending step and door frame shock. Risk management is used to identify risks associated with portable equipment handling.1 General 15.4.

6 15.3 Batteries 15. Risk management is used to justify the omission of fuses or over-current releases providing protection from excessive battery current.1 15.3.2.4.8 Internal wiring of ME EQUIPMENT 15.4.9 Oil containers b) a) Risk management is used to determine the probability of foot switches being used in areas where liquids are likely to be found.4.6.1 Housing 15.5 15. Risk management is used to address the risk of the failure of thermostat and the need for an over temperature thermal cutout.3 Protection against overcharging 15.4.4.2 15.7.7. prevention of maladjustment Limitation of movement Cord-connected HAND-HELD and foot-operated control 15.2 Connection 15.4.7 devices (see also 8.4.4.2. 117/120 .4.4. 15.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.4.3 Entry of liquids 15. The risk management file may provide some guidance for the incorrect connection or replacement of batteries.2 Temperature settings 15.4 Lithium batteries Risk management is used to address both battery ventilation and accidental short-circuiting.6. a) b) 15.4.3.4) 15.3. f). g) h) 15.4. Risk management is used to address the risk associated with heating elements making a condutive connection to earth that could result in over-heating.5 Excessive current and voltage protection 15.3. Risk management is used to address the risk of thermal cutouts that have to be reset by a soldering operation.1 Mechanical strength 15. management to risk management Comments Risk management is used to address the risk of automatic resetting thermal cut-outs and over-current releases.1 Application c) d) e). Risk management is used to address the risks associated with pre-set controls.3. The risk management file may address risks associated with over-charging the batteries.4 Indicators Pre-set controls Actuating parts of controls of ME EQUIPMENT Fixing. Risk management is used to address the risk of the loss of function caused by the operation of a thermal cut-out or overcurrent release.4.7.How risk management affects the requirement(s).2 Accidental operation of ME EQUIPMENT 15.4.4.4.10.4.4.

management to risk management Comments 15.1 15.9.5.2 15.3 16 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers providing separation in accordance with 8.1.5.1 16.5.2.4.5.5 Medical electrical systems Risk management is used to determine which configurations constitute the highest risks and which risk control measures are needed in any possible configuration to prevent an unacceptable risk.2 16.5 Overheating Transformers Short-circuit test Overload test Dielectric strength Construction of transformers used to provide separation as required by 8.1. Electromagnetic compatibility of ME EQUIPMENT and 17 ME SYSTEMS 118/120 .1 16.1 General requirements for the ME SYSTEMS ACCOMPANYING DOCUMENTS of an ME SYSTEM Power supply ENCLOSURES SEPARATION DEVICES LEAKAGE CURRENTS TOUCH CURRENT EARTH LEAKAGE CURRENT of MULTIPLE SOCKETOUTLET PATIENT LEAKAGE CURRENT Measurements General conditions for ME SYSTEMS Connection of the ME SYSTEM to the measuring supply circuit Protection against MECHANICAL HAZARDS Interruption of the power supply to parts of an ME SYSTEM ME SYSTEM connections and wiring Connection terminals and connectors MAINS PARTS.3 15.3 16.6 16.5.1 16.9.6.2.2 16.1 16.2 16. components and layout MULTIPLE SOCKET-OUTLET 16.6. 16.8 16.2 16.9.9.3 Protection of conductors Risk management is used to address the risk associated with use of the equipment in electromagnetic environments where it is expected to be used and the equipment's electromagnetic effect on that environment.4 16.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEMS 16.7 16.4.1 15.2.6.5 16.6.3 16.6.5.5 15.How risk management affects the requirement(s).2 15.4 16.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.9.6.9 16.1.

2 G.5 G.1 G.3 G.5.3 G.How risk management affects the requirement(s).1.4. parts and components thereof General Temperature limits Low-energy circuits External ventilation with internal overpressure ENCLOSURES with restricted breathing Requirements and tests for CATEGORY APG ME EQUIPMENT.3 G.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.1 Introduction Risk management is used to determine the probability of occurrence of ignition from anaesthetic mixtures depending on their concentration.3. ACCOMPANYING DOCUMENTS CATEGORY APG marking CATEGORY AP marking Placement of markings ACCOMPANYING DOCUMENTS Marking when parts of ME EQUIPMENT are CATEGORY AP or CATEGORY APG Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT Electrical connections Construction details Prevention of electrostatic charges Corona Requirements and tests for CATEGORY AP ME EQUIPMENT.1 G..5.3 OR NITROUS OXIDE ME EQUIPMENT specified for use with FLAMMABLE G.3 G.4 ANAESTHETIC MIXTURE WITH AIR G.4 G. management to risk management Comments Protection against HAZARDS of ignition of flammable G anaesthetic mixtures G.4 G.1 G.2.3. parts and components thereof General Power supply G.1 G.4 G.4 G.2 G.2 G.6.4.5.1 G.5 G.6.2.5 G.4.3 G.1. Applicability Industrial equipment and components Requirements for ME EQUIPMENT Locations and basic requirements Parts of CATEGORY APG ME EQUIPMENT FLAMMABLE ANAESTHETIC MIXTURE WITH AIR FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN G.5 G.5.4.2 119/120 .2.2 ME EQUIPMENT specified for use with FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Marking. ignition energy or high surface temperatures and the energy of sparking.2 G.1.3.5.1 G.2.3.6 G.3.2 G.2.

6.6.4 Heating elements G. management to risk management Comments G.APPENDIX A Clause 60601-1:2005 Topic Sub-parts applicable to risk Sub-parts not applicable General.How risk management affects the requirement(s).7 Test apparatus for flammable mixtures Means these clauses of ISO 14971 are not requied Means requires risk management investigation Means simply a heading no text Reference clause to another Means no risk management activity required 120/120 .3 Temperatures and low-energy circuits G.

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