ISO/IEC Guide 63:2019

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 2019
© ISO/IEC 2019
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Published in Switzerland
ii © ISO/IEC 2019 – All rights reserved

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
© ISO/IEC 2019 – All rights reserved iii

Annex A (informative) Product and process safety standards .24
Annex B (informative) Risk information .25
Bibliography .26
iv © ISO/IEC 2019 – All rights reserved

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.
© ISO/IEC 2019 – All rights reserved v

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.
vi © ISO/IEC 2019 – All rights reserved

Introduction
This document provides practical guidance to standards writers on how to include saf
...