Guide to the development and inclusion of aspects of safety in International Standards for medical devices

This document provides requirements and recommendations to writers of medical device standards on the inclusion of aspects related to safety in International Standards, based on well-established risk management concepts and methodology. This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these. In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.

Guide pour l'élaboration des aspects de sécurité et leur incorporation dans des Normes internationales relatives aux dispositifs médicaux

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Published
Publication Date
11-Aug-2019
Current Stage
6060 - International Standard published
Start Date
12-Jul-2019
Completion Date
12-Aug-2019
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GUIDE 63
Third edition
2019-08
Guide to the development and
inclusion of aspects of safety in
International Standards for medical
devices
Guide pour l'élaboration des aspects de sécurité et leur incorporation
dans des Normes internationales relatives aux dispositifs médicaux
Reference number
ISO/IEC GUIDE 63:2019(E)
ISO/IEC 2019
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ISO/IEC GUIDE 63:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO/IEC 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

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Published in Switzerland
ii © ISO/IEC 2019 – All rights reserved
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ISO/IEC GUIDE 63:2019(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Use of the terms “safety”, “safe”, “effective”, and “effectiveness” ......................................................................... 4

4.1 Safety ............................................................................................................................................................................................................... 4

4.2 Safe .................................................................................................................................................................................................................... 5

4.3 Effective ......................................................................................................................................................................................................... 5

4.4 Effectiveness ............................................................................................................................................................................................. 5

5 Principles for including aspects of safety in medical device standards .....................................................5

5.1 Scope of medical device standards that include aspects of safety ............................................................. 5

5.2 Objective of medical device standards that include aspects of safety ..................................................... 6

5.3 Types of standards ............................................................................................................................................................................... 6

5.3.1 Product standards .......................................................................................................................................................... 6

5.3.2 Process standards ........................................................................................................................................................... 6

5.3.3 Installation and environmental standards ................................................................................................ 7

5.3.4 In-service standards ..................................................................................................................................................... 7

5.4 Taking a practical view of safety .............................................................................................................................................. 7

5.5 Coordination of medical device standards ..................................................................................................................... 7

5.6 Implications of the regulatory or legal use of standards .................................................................................... 8

6 The nature of risk ................................................................................................................................................................................................ 8

6.1 The elements of risk ........................................................................................................................................................................... 8

6.2 Systematic or random nature of risks ................................................................................................................................. 9

6.2.1 Types of causes of risks .............................................................................................................................................. 9

6.2.2 Risks arising from systematic causes ..........................................................................................................10

6.2.3 Risks arising from random causes .................................................................................................................10

7 Risk-based process for developing a medical device standard that includes aspects

of safety .......................................................................................................................................................................................................................10

7.1 General ........................................................................................................................................................................................................10

7.2 Preparatory work ..............................................................................................................................................................................11

7.2.1 Identifying the need for a new or revised standard including aspects of safety ...11

7.2.2 Establishing the risk management framework under which the standard

will be developed ........................................................................................................................................... ...............11

7.2.3 Risk acceptability criteria .....................................................................................................................................12

7.3 Drafting .......................................................................................................................................................................................................14

7.3.1 General...................................................................................................................................................................................14

7.3.2 Iterative process of managing risk ................................................................................................................14

7.3.3 Intended use and characteristics that can influence safety .....................................................16

7.3.4 Identification of hazards and hazardous situations .......................................................................17

7.3.5 Risk estimation ...............................................................................................................................................................18

7.3.6 Risk evaluation ...............................................................................................................................................................19

7.3.7 Identification of risk controls ............................................................................................................................19

7.3.8 Verification of effectiveness.................................................................................................................................22

7.3.9 Assessment of residual risks ..............................................................................................................................22

7.3.10 Impact of introduced risk control measures ........................................................................................22

7.3.11 All identified hazards and hazardous situations considered .................................................22

7.4 Validation of the standard ..........................................................................................................................................................22

7.5 Conclusion ................................................................................................................................................................................................22

8 Overview of the application of medical device standards including aspects of safety

in a risk management framework ...................................................................................................................................................22

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ISO/IEC GUIDE 63:2019(E)

Annex A (informative) Product and process safety standards ...............................................................................................24

Annex B (informative) Risk information .......................................................................................................................................................25

Bibliography .............................................................................................................................................................................................................................26

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ISO/IEC GUIDE 63:2019(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that

are members of ISO or IEC participate in the development of International Standards through

technical committees established by the respective organization to deal with particular fields of

technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other

international organizations, governmental and non-governmental, in liaison with ISO and IEC, also

take part in the work.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject

of patent rights. ISO and IEC shall not be held responsible for identifying any or all such patent

rights. Details of any patent rights identified during the development of the document will be in the

Introduction and/or on the ISO list of patent declarations received (see www .iso .org/patents) or the IEC

list of patent declarations received (see http: //patents .iec .ch).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO’s adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso

.org/iso/foreword .html.

ISO/IEC Guide 63 was prepared by a Joint Working Group of ISO/TC 210, Quality management and

corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical

equipment used in medical practice.

This third edition cancels and replaces the second edition (ISO/IEC Guide 63:2012), which has been

technically revised.
The main changes compared with the previous edition are as follows:

― restructuring of content to more closely follow the structure of ISO/IEC Guide 51:2014;

― revision of clause numbering, including the inclusion of Clause 2 on normative references, in

order to respect the fixed clause structure for the first three clauses specified in the ISO/IEC

Directives, Part 2;

― updating of defined terms in Clause 3, with many derived from ISO/IEC Guide 51:2014, and the

definitions of “manufacturer” and “medical device” now based on the GHTF guidance documents

GHTF/SG1/N055: 2009 and GHTF/SG1/N071: 2012;

― addition of new content in Clause 4 to provide guidance on the use of the terms “safety”, “safe”,

“effective” and “effectiveness”;

― reorganization of existing content into Clause 5 discussing the principles, Clause 6 discussing the

nature of risk, Clause 7 focusing on the process for developing standards that include aspects of

safety, and Clause 8 providing an overview of the application of medical device standards;

― revision of Figure 1 to better illustrate how a sequence of events can transform a hazard into a

hazardous situation that can lead to harm;
― addition of Figure 2 to illustrate the iterative process of risk management.
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ISO/IEC GUIDE 63:2019(E)

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/members .html.
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ISO/IEC GUIDE 63:2019(E)
Introduction

This document provides practical guidance to standards writers on how to include safety aspects in the

development of medical device standards, including management system standards related to medical

devices. This document is based on risk management principles and ISO/IEC Guide 51:2014 to address

the needs of the medical device sector.

The concept of safety, as described in this document, is closely related to protecting patients who

are the subjects of medical care, as well as those persons who provide the care and other potentially

affected persons. Safety is also related to harm to property or the environment.

The approach described in this document aims to reduce the risk arising during the life cycle of a

medical device, including design, production, distribution, installation, use, service, maintenance, and

destruction or disposal. The complete life cycle of a medical device (including both the intended use

and the reasonably foreseeable misuse) is considered. The goal is to achieve acceptable risk for people,

property and the environment.

As different circumstances warrant different approaches to ensuring safety, it is impossible to provide

precise requirements and recommendations that apply to every case. Examples of such differences

are the development of standards for manufacturers of medical devices and standards for health care

providers and institutions. However, this document, when followed on a judicious “use when applicable”

basis, will help in developing standards that include aspects of safety which are consistent with the

generally acknowledged state of the art.

NOTE The term “standard” used throughout this document includes International Standards, Technical

Specifications, Publicly Available Specifications, Technical Reports and Guides developed by ISO or IEC.

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GUIDE ISO/IEC GUIDE 63:2019(E)
Guide to the development and inclusion of aspects of safety
in International Standards for medical devices
1 Scope

This document provides requirements and recommendations to writers of medical device standards

on the inclusion of aspects related to safety in International Standards, based on well-established risk

management concepts and methodology.

This document is applicable to any aspect related to the safety of people, property, the environment, or

a combination of these.

In this document, the term “product” includes a medical device or a system consisting of one or more

medical devices, possibly combined with non-medical devices.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
harm

injury or damage to the health of people, or damage to property or the environment

[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.2
hazard
potential source of harm (3.1)
[SOURCE: ISO/IEC Guide 51:2014, 3.2]
3.3
hazardous situation

circumstance in which people, property or the environment is/are exposed to one or more hazards (3.2)

[SOURCE: ISO/IEC Guide 51:2014, 3.4]
3.4
intended use

use for which a product, process or service is intended according to the specifications, instructions and

information provided by the manufacturer (3.6)

Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted

with, user profile, use environment, and operating principle are typical elements of the intended use.

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ISO/IEC GUIDE 63:2019(E)
3.5
life cycle

series of all phases in the life of a medical device (3.7), from the initial conception to final decommissioning

and disposal
3.6
manufacturer

natural or legal person with responsibility for design and/or manufacture of a medical device (3.7) with

the intention of making the medical device available for use, under his name; whether or not such a

medical device is designed and/or manufactured by that person himself or on his behalf by another

person(s)

Note 1 to entry: This "natural or legal person" has ultimate legal responsibility for ensuring compliance with all

applicable regulatory requirements for the medical device in the countries or jurisdictions where it is intended to

be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory

Authority within that jurisdiction.

Note 2 to entry: The manufacturer’s responsibilities are described in other GHTF guidance documents. These

responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse

event reporting and notification of corrective actions.

Note 3 to entry: “Design and/or manufacture” can include specification development, production,

fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or

remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for

a medical purpose.

Note 4 to entry: Any person who assembles or adapts a medical device that has already been supplied by another

person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided

the assembly or adaptation does not change the intended use (3.4) of the medical device.

Note 5 to entry: Any person who changes the intended use of, or modifies, a medical device without acting on

behalf of the original manufacturer and who makes it available for use under his own name, should be considered

the manufacturer of the modified medical device.

Note 6 to entry: An authorized representative, distributor or importer who only adds its own address and

contact details to the medical device or the packaging, without covering or changing the existing labelling, is not

considered a manufacturer.

Note 7 to entry: To the extent that an accessory is subject to the regulatory requirements of a medical device, the

person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.

[SOURCE: GHTF/SG1/N055: 2009, 5.1, modified - The words "may include" have been replaced with "can

include" in Note 3 to entry.]
3.7
medical device

instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,

material or other similar or related article, intended by the manufacturer (3.6) to be used, alone or in

combination, for human beings, for one or more of the specific medical purpose(s) of

— diagnosis, prevention, monitoring, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

— investigation, replacement, modification, or support of the anatomy or of a physiological process,

— supporting or sustaining life,
— control of conception,
— disinfection of medical devices,

— providing information by means of in vitro examination of specimens derived from the human body,

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ISO/IEC GUIDE 63:2019(E)

and which does not achieve its primary intended action by pharmacological, immunological or metabolic

means, in or on the human body, but which can be assisted in its intended function by such means

Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in others

include:
— disinfection substances,
— aids for persons with disabilities,
— devices incorporating animal and/or human tissues,
— devices for in-vitro fertilization or assisted reproductive technologies.

[SOURCE: GHTF/SG1/N071: 2012, 5.1, modified — The words "may be assisted" have been replaced

with "can be assisted" in the definition, and the words "may be considered" have been replaced with

"can be considered" in Note 1 to entry.]
3.8
reasonably foreseeable misuse

use of a product or system in a way not intended by the manufacturer (3.6), but which can result from

readily predictable human behaviour

Note 1 to entry: Readily predictable human behaviour includes the behaviour of all types of users, e.g. lay and

professional users.

Note 2 to entry: Reasonably foreseeable misuse can be intentional or unintentional.

[SOURCE: ISO/IEC Guide 51:2014, 3.7, modified — The word “supplier” has been replaced with

“manufacturer”, the example in Note 1 to entry has been modified, and Note 2 to entry has been

replaced with a new Note to entry.]
3.9
residual risk
risk (3.10) remaining after risk control (3.12) measures have been implemented

[SOURCE: ISO/IEC Guide 51:2014, 3.8, modified — The words “risk reduction measures” have been

replaced with “risk control measures”.]
3.10
risk

combination of the probability of occurrence of harm (3.1) and the severity (3.17) of that harm

Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.3) and the

possibility to avoid or limit the harm.

[SOURCE: ISO/IEC Guide 51:2014, 3.9, modified — The words "the occurrence of a hazardous event"

have been removed from Note 1 to entry.]
3.11
risk analysis

systematic use of available information to identify hazards (3.2) and to estimate the risk (3.10)

[SOURCE: ISO/IEC Guide 51:2014, 3.10]
3.12
risk control

process in which decisions are made and measures implemented by which risks (3.10) are reduced to,

or maintained within, specified levels
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ISO/IEC GUIDE 63:2019(E)
3.13
risk estimation

process used to assign values to the probability of occurrence of harm (3.1) and the severity (3.17) of

that harm
3.14
risk evaluation

process of comparing the estimated risk (3.10) against given risk criteria to determine the acceptability

of the risk
3.15
risk management

systematic application of management policies, procedures and practices to the tasks of analysing,

evaluating, controlling and monitoring risk (3.10)
3.16
safety
freedom from unacceptable risk (3.10)
3.17
severity
measure of the possible consequences of a hazard (3.2)
3.18
state of the art

developed stage of technical capability at a given time as regards products, processes and services,

based on the relevant consolidated findings of science, technology and experience

Note 1 to entry: The state of the art embodies what is currently and generally accepted as good practice in technology

and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state

of the art described here is sometimes referred to as the “generally acknowledged state of the art”.

[SOURCE: ISO/IEC Guide 2:2004, 1.4, modified — Note 1 to entry has been added.]
3.19
verification

confirmation, through the provision of objective evidence, that specified requirements have been

fulfilled

Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other

forms of determination such as performing alternative calculations or reviewing documents.

Note 2 to entry: The activities carried out for verification are sometimes called a qualification process.

Note 3 to entry: The word “verified” is used to designate the corresponding status.

[SOURCE: ISO 9000:2015, 3.8.12]
4 Use of the terms “safety”, “safe”, “effective”, and “effectiveness”
4.1 Safety

The use of the term “safety” in medical device standards should be as a noun rather than as a descriptive

adjective. As an adjective, it is likely to be misinterpreted as an assurance of freedom from risk. The

recommended approach is to replace, wherever possible, the terms “safety” with an indication of the

objective.

EXAMPLE “Protective helmet” instead of “safety helmet”; “protective impedance device” instead of “safety

impedance".
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ISO/IEC GUIDE 63:2019(E)
4.2 Safe

The term “safe” in medical device standards should be used to indicate the state where the risks from

recognized hazardous situations have been reduced to an acceptable level.

The term “safe” should only be used with the term “effective” to describe the situation where a balance

has been achieved between the state where the risks from recognized hazardous situations have been

reduced to an acceptable level and the product is achieving the intended use. Other uses of safe should

be replaced, whenever possible, with an indication of the objective.
EXAMPLE “Slip resistant floor-covering” instead of “safe floor-covering”.
4.3 Effective

The term “effective” in medical device standards should be used to characterize a medical device that

fulfils its intended use.
4.4 Effectiveness

The term “effectiveness” can be used in medical device standards to express a variety of related

concepts depending upon the context of where it is used. Standards writers need to carefully establish

the meaning within the context of their standard, if it differs from the context established in this

document, and then use it consistently. In this document, the term is used in the context of verification

of risk control measures.

EXAMPLE In IEC 62366-1:2015, 3.4, "effectiveness" is defined as "accuracy and completeness with which

users achieve specified goals". In IEC 80001-1:2010, 2.6, "effectiveness" defined as "ability to produce the

intended result for the patient and the responsible organization".
5 Principles for including aspects of safety in medical device standards
5.1 Scope of medical device standards that include aspects of safety

The planning and development of medical device standards that include aspects of safety requires a

global approach that includes manufacturers, users, regulatory authorities and other stakeholders.

This document is intended to assist committees responsible for different medical device standards to

create a coherent approach to the treatment of safety in the preparation of those standards. Defining

the scope of these standards will ensure that each standard is restricted to specific aspects and that

each standard makes reference to standards of wider application for all other relevant aspects. A useful

hierarchy is built on:

— basic standards, including fundamental concepts, principles and requirements with regard to

general aspects of safety applicable to all kinds or a wide range of products, processes and services

(basic standards are sometimes referred to as horizontal standards);

— group standards, including aspects of safety applicable to several products, processes or services

dealt with by two or more technical committees or subcommittees, making reference, as far as

possible, to basic standards;
— (a
...

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