EMI for Testing Medical Devices (application note 10/04) Introduction The Medical Devices Directive (MDD), and

the related Active Implantable Devices Directive, cover the safety of medical devices that may come into contact with patients, and include requirements for manufacturers of such products to take EMC related functional safety into account, as well as EMC in general. European legislation on medical devices The Medical Devices Directive was adopted in June 1993. The intention was for Member States to adopt and publish the laws, regulations and administration provisions necessary to comply with this directive not later than 31 December 1993. The provisions were applied with effect from 1 July 1994. There are two other directives relating to devices and equipment used for medical purposes: 1. The Active Implantable Medical Devices Directive 90/385/EEC. 2. The In Vitro Diagnostic Devices Directive 98/79/EC. All three of these groups of devices can have electrical or electronic systems or components either incorporated into them or connected to them as part of their operating function and so are in some degree likely to cause or be affected by electromagnetic disturbance. The results of these effects are potentially far more serious in the case of the Medical and Active Implantable Devices as they are attached to or inserted into the human body and any malfunction could have serious health and safety consequences. There are several EMC specifications, but none of them alone will provide appropriate testing guidelines for specialized medical devices. To reduce confusion and ensure that devices will be properly tested, medical manufacturers should use an existing standard as a guide for developing a customized testing plan. EMC Standards for Medical Devices: IEC 60601-1-2 The International Electrotechnical Commission (IEC) is a worldwide body that promotes international standardization in electronics. In 1993 it released the 60601-1-2 standard, Medical Electrical Equipment Part 1: General Requirements for Safety, Amendment No. 2. Collateral Standard: Electromagnetic Compatibility Requirements and Tests. The IEC 60601 standard offers a solid basis for medical device testing. Although they are relatively new, the IEC 60601-1-2 requirements have quickly become recognized throughout the world and are instrumental in testing to the European Medical Devices Directive. Organizations such as the American National Standards Institute (ANSI) use the IEC 60601 standard as a basis for their own requirements. This document specify emission levels. However, these levels may not be strict enough to ensure that equipment will operate as intended. Manufacturers should use the IEC specifications as a guide but tailor them to produce product-specific limits. The scope of the Standard includes Medical Electrical Equipment, Medical Electrical Systems, Information Technology equipment used in medical electrical applications and all other equipment forming part of medical electrical systems.

Application Note 10/04: EMI for Testing Medical Devices

Test Specifications and Limits The IEC 60601-1-2 standard specifies test limits for emissions, immunity, electrostatic discharge (ESD), radiated RF electromagnetic fields, bursts, and surges. Emissions requirements Devices shall comply with the relevant requirements of CISPR 11 that contains limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment. ISM equipment is classified into classes and groups: Group 1: Group 2: Class A: Class B: All ISM equipment in which there is internally generated and used, conductively coupled RF energy necessary for the internal functioning of the equipment. All ISM equipment in which RF energy is internally generated an/or used in the form of electromagnetic radiation for the treatment of material and spark erosion equipment Equipment is suitable for use in other than domestic establishments and those connected to the domestic power supply Equipment is suitable for use in domestic establishments.

There are different limits for the two classes. Limits are specified for terminal disturbance voltage (conducted emission) and for radiated emissions. CISPR 11 is specific in that although Class A equipment can be measured in situ, Class B must be assessed on a test site. The collateral Standard relaxes this, allowing compliance for a specific model to be demonstrated by a type test of one unit on a typical user site. In addition type testing of a sub system or system on a test site or in situ under normal operating conditions may be used to demonstrate compliance. An additional allowance is for ITE certified to CISPR 22 to be included in systems without further verification. Class A ITE may only be included in Class A systems, while Class B ITE can be included in both Class A and B. Medical equipment not containing any electronics generating frequencies over 9kHz, may be tested according to CISPR 14. This does not apply to systems, which need to meet CISPR 11. Lighting equipment used in medical applications may be tested to CISPR 15. CISPR 11 covers a frequency range from 150kHz to 1GHz. Conducted emissions for low- and mediumvoltage power mains (100415V) are performed from 150kHz to 30MHz. The frequency range for radiated emissions is from 150kHz to 1GHz. Depending on the class and use of the equipment, various frequency ranges may be defined (see note below). Amplitude limits in general are established to protect the public broadcast services, not for equipment that may have to operate in close proximity to sensitive medical equipment. The specification also refers to frequencies designated by the International Telecommunication Union: 2450 MHz for industrial, 5800 MHz for scientific, and 24,125 MHz for medical equipment. Custom Standards Manufacturers of electrical and electronic equipment for any use are recognizing the need for specifications that ensure compatibility among equipment. Medical electronics manufacturers also recognize that such generic standards are not necessarily appropriate; they may be too severe, or, even worse, not severe enough to protect their products.

Application Note 10/04: EMI for Testing Medical Devices

To lessen confusion and to ensure that test specifications will be appropriate, medical manufacturers should use an existing document such as IEC 60601-1-2 as a basis for creating their own product-specific standards. References Standards: IEC 60601-1-2: Medical Electrical Equipment Part 1: General Requirements for Safety, Amendment No. 2. Collateral Standard: Electromagnetic CompatibilityRequirements and Tests CISPR 11: Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Radio Frequency Equipment (Excluding Surgical Diathermy Apparatus) CISPR 14: Limits and Methods of Measurements of Radio Interference Characteristics of Household Electrical Appliances, Portable Tools and Similar Electrical Apparatus Note The further amendments to CISPR 11 contribute some important clarifications to that document. They added certain lighting devices to the scope of the standard, i.e. ISM lighting apparatus operating in the protected frequency bands of 915MHz, 2.45GHz, and 5.8GHz. It has changed antenna measurement distances for an important class of product (Class A, Group 1 equipment), allowing EMC testing laboratories to make measurements at a 10-m distance, either inside an absorber-lined chamber or on an OATS, instead of at 30 m. Amendments introduced significant changes in the requirements of CISPR 11 for the frequency range from 1GHz to 18GHz. Limits have be introduced for: Electromagnetic radiation disturbance peak limits for Group 2, Class B ISM equipment producing CWtype disturbances and operating at frequencies above 400 MHz. Electromagnetic radiation disturbance peak limits for Group 2, Class B ISM equipment producing fluctuating disturbances other than CW and operating at frequencies above 400 MHz. Electromagnetic radiation disturbance weighted limits for Group 2, Class B ISM equipment operating at frequencies above 400 MHz.

Application Note 10/04: EMI for Testing Medical Devices

Ordering Information

Receivers ER55C ER55R ER55CR ER55CR/2.8 CISPR16-1 EMI Receiver for conducted emission, f=9kHz-30MHz, complete with: Windows software, Internal generator for auto-calibration and TRANSIENT LIMITER. CISPR16-1 EMI Receiver for radiated emission, f=30kHz-1000MHz, complete with: Windows software, Internal generator for auto-calibration and TRANSIENT LIMITER. CISPR16-1 EMI Receiver for conducted and radiated emission, f=9kHz-1000MHz, complete with: Windows software, Internal generator for auto-calibration and TRANSIENT LIMITER. CISPR16-1 EMI Receiver for conducted and radiated emission, f=9kHz-2800MHz, complete with: Windows software, Internal generator for auto-calibration and TRANSIENT LIMITER.

Transducers for Conducted Emission Single phase Artificial Mains Network (LISN), 2 x 16A according to CISPR 16, f= 9kHzLS 16C 30MHz, manual & automatic phase control (32A for 10m.) Three Phases Artificial Mains Network (LISN), 4 x 32A according to CISPR 16, f=9kHzLT 32C 30MHz, manual & automatic phase control (64A for 10m). Three Phases Artificial Mains Network (LISN), 4 x 100A according to CISPR 16, f=150kHzLT 100 30MHz, manual & automatic phase control (64A for 10m). HVP1 High Voltage Probe according to CISPR 16-1, 35 dB attenuation, Vmax 380V. HVP1/1000 High Voltage Probe according to CISPR 16-1, 35 dB attenuation, Vmax 1000V. Broadband Antenna for Radiated Emission Broadband-Hybrid-Antenna, f=30MHz 2000MHz, including calibration certificate for 3,0m and BTA-H 10,0m measuring distance (up to 2GHz Broadband-Hybrid-Antenna f=30MHz 3000MHz, including calibration certificate for 3,0m and BTA-M 10,0m measuring distance (up to 3GHz) Lighting equipment used in medical applications may be tested to CISPR 15 L IS V- LISN 150, per insertion loss measurement, according to CISPR 15, 150kHz 30MHz BUT Balance-to-unbalance Transformer, per insertion loss measurement, according to CISPR 15 TLA 300 2m Van Veen Loop Antenna, according to CISPR 15 Kal kit Calibration Loop for any Van Veen Loop antenna, according to CISPR 15 DL All sets of Dummy lamps: linear, circular, U-type, Click Analyser (Medical equipment not containing any electronics generating frequencies over 9kHz, may be tested according to CISPR 14) Click meter, fully compliant to CISPR 16-1 & CISPR 14-1, with 4 fixed frequency modules, CL55C 150kHz, 500kHz, 1.4MHz, 30MHz for simultaneous measurements complete with windows software.

Application Note 10/04: EMI for Testing Medical Devices