Lecture 4: Use of Standards For Medical Device: Chung Tin, PH.D

BME3104 Health Maintenance and Wellness Technology 1
Lecture 4: Use of Standards for Medical

Device
Chung Tin, Ph.D.
Email: chungtin@cityu.edu.hk
Office: P6416
Standards for MD
Why we need standards?
• e.g. “Large” electrical current can cause:
• Respiratory arrest
• Pain
• Ventricular fibrillation
• Burns and physical injuries
• Death
• But how large current will lead to that??
• Standards: Suggest the limitation and

provide guidelines to help minimize the
potential risk of electric shock
What is Standard?
• Standards are documented agreements containing technical
specifications or other precise criteria to be used consistently
as rules, guidelines or definitions of characteristics, to ensure
that materials, products, process and services are fit for their
purpose
• Specifications can include
• Prescriptive Specification
• Design Specification
• Performance Specification
• Management Specification
What is Standard?
• Specifications can include
• Prescriptive Specifications
• obligate product characteristics, e.g. device dimensions, biomaterials, test or
calibration procedures, as well as definitions of terms and terminologies
• Design Specifications
• Set out specific design or technical characteristics of a product, e.g.
operating room facilities or medical gas systems
• Performance Specifications
• Ensure product meets a prescribed test, e.g. strength requirements,
measurement accuracy, battery capacity or max. defibrillator energy
• Management Specifications
• requirements for the processes and procedures companies put in place, e.g.
quality systems for manufacturing or environmental management systems.
Purpose of Standard
1. Provide reference criteria that a product, process or service must
meet.
2. Provide information that enhances safety, reliability and
performance of products, processes and services.
3. Assure consumers about reliability or other characteristics of
goods or services provided in the marketplace.
4. Give consumers more choice by allowing one firm’s products to
be substituted for, or combined with, those of another
What makes a good Standard?

1. Their development has been overseen by a recognized body, thus
ensuring that the process is transparent and not dominated by vested
interests.
2. The development process has been open to input from all interested
parties and the resulting document based on consensus. Consensus, in
a practical sense, means that significant agreement among the
stakeholders is reached in the preparation of the standard, including
steps taken to resolve all objections. This process implies more than
the votes of a majority, but not necessarily unanimity.
3. Good technical standards are based on consolidated results of science,
technology and experience, and are aimed at the promotion of optimum
community benefits.
4. Standards do not hinder innovations and must be periodically reviewed
to remain in tune with technological advances
How to make sure one is conforming to a Standard?

1. Assess by direct testing
2. Assess by audit and authorizing the display of the
corresponding certification mark.
3. By Management System Registration bodies (Registrars)
who issue registration certificates to companies that meet
a management standard such as ISO9000, or to medical
device manufacturers that meet the ISO13485/ISO9001
standards.
4. By Accreditation which is used by an authoritative body to
give formal recognition that an organization or a person is
competent to carry out a specific task.
• e.g. Notified Bodies in Europe
National Standards Systems

A country usually has one official national organization that coordinates and
accredits the many (voluntary) standards development bodies in that
country
Examples:
• In United States, American National Standards Institute (ANSI)
• In Canada, Standards Council of Canada (SCC)
• In Europe, a committee composed of CEN (Comité Européen de
Normalisation), CENELEC (the European Committee for Electrotechnical
Standardization) and ETSI (the European Telecommunication Standards
Institute)
International Standards Systems

Three major international standardization organizations:
• The International Organization for Standardization (ISO)
• The International Electrotechnical Commission (IEC)
• The International Telecommunication Union (ITU)
Generally speaking,
• IEC covers electrical and electronics engineering
• ITU covers telecommunications
• ISO covers the rest
For information technology, risk management, quality systems and many

other areas, joint ISO/IEC technical committees manage standardization.
Naming of Standards
Examples
• CAN/CSA-Z386-94 means a standard developed in 1994 by the Canadian
Standards Association (CSA, one of four accredited Canadian standards
development organizations) and designated by the Standards Council of
Canada (SCC) as a Canadian national standard.
• ANSI/AAMI/ISO 15223:2000 means the international standard ISO 15223
(established in 2000) adopted by the Association for the Advancement of
Medical Instrumentation (AAMI) in the United States, which in turn is designated
by the American National Standards Institute (ANSI) as an American national
standard.
Standards for Medical Device
More…
Standards for Quality Management

• ISO 9000: Well-known standard for QMS of Business
• ISO 9000 + Additional healthcare-related requirements =
ISO 13485: QMS for Medical devices
ISO 13485 (1996-) vs ISO 9001 (1987-)

ISO 9001
• focuses on business management standards rather than the
product itself
ISO 13485
• Risk management required at all stages of product realization
• Training and supervision of staff
• Contamination prevention
• Multiple documentation requirements
• Monitoring whether customer requirements are met, rather than
more subjective customer satisfaction measures
• Maintaining the continued suitability and effectiveness of the
quality management system, rather than striving for continuous
improvement
ISO 13485
Specific to Medical Device industry
1. Product Identification
• Procedures for identification of devices regarding their
production, change, and quality status
2. Traceability
• Procedures for tracing devices to facilitate corrective &
preventive action
3. Process Control and Cleanliness of product

• Requirements for cleanliness of devices if cleanliness is of
significance to their use & manufacture
ISO 13485
4. Maintenance
• Requirements for maintenance activities, and records of such
maintenance should be kept
5. Installation
• Instructions & acceptance criteria for installation & checking,
and retain the records
6. Computer software used in process control

• Procedures for validation of application of software used for
process control, and record the results
Standards for Medical Device Safety

IEC 60601
- Issued by International
Electrotechnical Commission (IEC)
- A series of technical standards for
safety and effectiveness of medical
electrical equipment
- There are also
- IEC 61010 (e.g. device not in contact with
patient)
- IEC 62336 (about usability)
- IEC 62304 (for software)
- etc.
IEC 60601 (3rd edition)

• Scope:
• For the Basic Safety and Essential Performance of Medical Device and
Medical Equipment Systems
• It does NOT apply to in-vitro diagnostic equipment, implantable parts of
active implantable medical devices and medical gas pipeline systems
• Consists of Collateral Standards (IEC 60601-1-x) and Particular Standards

(IEC 60601-2-x)
• IEC 60601-1-x: • IEC 60601-2-x:

• Safety requirements • Cardiac defibrillators
• Electromagnetic compatibility • Ultrasonic physiotherapy
• Radiation protection equipment
• Usability, guidance for alarm systems • Endoscopic equipment
• Environmentally conscious design… • X-ray equipment
• MR scanners
• EEG
Collateral Standards – Definitions

1. Equipment Under Test
• The equipment (EUT) which is the subject of testing.
2. Device Under Test
• The equipment (DUT) which is the subject of testing.
3. Applied Part
• Part of the medical equipment which is designed to come into physical
contact with the patient or parts that are likely to be brought into contact
with the patient.
4. Patient Connection
• Individual physical connections and / or metal parts intended for
connection with the patient which form (part of) an Applied Part.
5. Patient Environment
• Volumetric area in which a patient can come into contact with medical
equipment or contact can occur between other persons touching medical
equipment and the patient, both intentional and unintentional
Collateral Standards - Commonly Used

Symbols
Defibrillation-proof
Class I Type BF Applied Part
Class II Type CF Applied Part
Type B Applied Part Defibrillation-proof

Type CF Applied Part
Defibrillation-proof
Type B Applied Part CE Marking
Type BF Applied Part


• Class I:
• Protection against electronic shock does not rely
on basic insulation only
• Includes an additional safety precaution
(protectively earthed)
• Class II (Double insulated)

• Protection against electric shock does not rely on
basic insulation only
• Includes an additional safety precautions (double
insulation or reinforced insulation)
• no provision for protective earthing or reliance upon
installation conditions

• Type B (Body):
• Applied part not covered by Type BF or CF
• Least stringent classification
• Applied parts that are normally not conductive and can be
immediately released from the patient
• Not include direct cardiac application
• e.g. LED operating lighting, medical lasers, MRI body
scanners, hospital beds and phototherapy equipment.
• Type BF (Body floating):

• Applied parts that have conductive contact with the patient,
or have medium or long term contact with the patient
• Not include direct cardiac application
• e.g. Infusion pump, nerve stimulator, ECG equipment

• Type CF (cardiac floating):
• Applied part specified for direct cardiac application
• e.g. Cardiac catheter, pacemaker, dialysis machines
• Defibrillation-proof applied part

• Applied part protected against the effects of a discharge of
a cardiac defibrillator to the patient
Current Leakage
IEC 60601-1 is a lot of ”electrical safety”
• For example, the heart stops if the current persists for:
a) 250msec at 40mA
b) 100msec at 100mA
c) 50msec at 200mA
• When current applied to your skin

0.9–1.2mA Current just perceptible
15.0–20.0mA Release impossible: cannot be
tolerated over 15 minutes
50.0–100.0mA Ventricular fibrillation, respiratory
arrest, leading directly to death
100.0–200.0mA Serious burns and muscular
contraction of such a degree that
the thoracic muscles constrict the
heart
How much current is required to power a 25W light bulb?

Current Leakage
IEC 60601-1 is a lot of ”electrical safety”
• prevent any patient or operator being exposed to currents not part of
the functional operation of the device. These currents are referred
to as leakage currents.
• Including
1. Earth Leakage
2. Enclosure Leakage
3. Applied Part or Patient Leakage
• IEC 60601-1 requires to minimizing the probability of ventricular
fibrillation to a factor as low as 0.002
• e.g. Limit of 10μA for CF Applied Part under normal condition
• Need to be tested under Normal Condition and Single Fault

Condition (SFC)
IEC 60601-1 limits
http://www.rigelmedical.com/downloads/Rigel-Medical-A-Practical-guide-to-IEC-60601-1.pdf
Electrical Safety Analyzing Tool

Electrical Medical Safety Analyzer
Measuring device / Body Model
Current Leakage
Earth leakage current
• Current flowing from the mains part through or across
the insulation into the protective earth conductor or a
functional earthed connection
Current Leakage
Earth leakage current
Normal Conditions Single Fault Conditions (supply open)
• S1 Closed • S1 Open
• S5 normal and then S5 reversed • S5 normal and then S5 reversed
AP
MD – measuring device or body model

Current Leakage
Touch current / Enclosure leakage current
• Leakage current flowing from the enclosure or from
parts thereof, excluding patient connections, accessible
to any operator or patient in normal use
Current Leakage
Touch current / Enclosure leakage current
Normal Conditions Single Fault Conditions
• S1 and S8 Closed 1. Supply Open
• S5 normal and then S5 reversed • S1 Open and S8 Closed
• S5 normal and then S5 reversed
2. Earth Open
• S1 Closed and S8 Open
Current Leakage
Patient leakage current
• Current flowing from the patient connections via the
patient to earth
Current Leakage
Patient leakage current
Normal Conditions Single Fault Conditions
• S1 and S8 Closed 1. Supply Open
• S5 normal and then S5 reversed • S1 Open and S8 Closed
2. Earth Open
• S1 Closed and S8 Open
For Type CF – measure from each Applied

part separately
For Type B and BF – measure with all Applied

parts connected together
Some other relevant standards

• ISO 10993 – related to biocompatibility of MD
• ISO 14971 – related to risk management of MD (risk analysis, evaluation and
control)

Lecture 4: Use of Standards For Medical Device: Chung Tin, PH.D

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BME3104 Health Maintenance and Wellness Technology 1

Lecture 4: Use of Standards for Medical

• But how large current will lead to that??

• Standards: Suggest the limitation and

What makes a good Standard?

How to make sure one is conforming to a Standard?

National Standards Systems

International Standards Systems

For information technology, risk management, quality systems and many

Standards for Medical Device

Standards for Quality Management

ISO 13485 (1996-) vs ISO 9001 (1987-)

3. Process Control and Cleanliness of product

6. Computer software used in process control

Standards for Medical Device Safety

IEC 60601 (3rd edition)

• Consists of Collateral Standards (IEC 60601-1-x) and Particular Standards

• IEC 60601-1-x: • IEC 60601-2-x:

Collateral Standards – Definitions

Collateral Standards - Commonly Used

Class II Type CF Applied Part

Type B Applied Part Defibrillation-proof

Type BF Applied Part

Collateral Standards – Definitions

• Class II (Double insulated)

Collateral Standards – Definitions

• Type BF (Body floating):

Collateral Standards – Definitions

• Defibrillation-proof applied part

• When current applied to your skin

How much current is required to power a 25W light bulb?

• Need to be tested under Normal Condition and Single Fault

IEC 60601-1 limits

Electrical Safety Analyzing Tool

Measuring device / Body Model

MD – measuring device or body model

For Type CF – measure from each Applied

For Type B and BF – measure with all Applied

Some other relevant standards

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