ISO/TR 80002-2:2017

TECHNICAL ISO/TR
REPORT 80002-2
First edition
2017-06
Medical device software —
Part 2:
Validation of software for medical
device quality systems
Logiciels de dispositifs médicaux —
Partie 2: Validation des logiciels pour les systèmes de qualité des
dispositifs médicaux
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Software validation discussion . 1
4.1 Definition . 1
4.2 Confidence-building activities: Tools in the toolbox . 1
4.3 Critical thinking . 2
5 Software validation and critical thinking . 2
5.1 Overview . 2
5.2 Determine if the software is in scope . 6
5.2.1 Document a high-level definition of the process and use of the software . 6
5.2.2 Regulatory use assessment . 6
5.2.3 Processes and software extraneous to medical device regulatory requirements . 6
5.3 Development phase. 7
5.3.1 Validation planning . 7
5.3.2 Define . 7
5.3.3 Implement, test and deploy .11
5.4 Maintain phase .13
5.4.1 Entering the maintenance phase .13
5.4.2 Planning for maintenance .14
5.4.3 Types of maintenance within the maintain phase .15
5.4.4 Process changes: Change to risk control measures .15
5.4.5 Emergency change .15
5.4.6 Maintaining for intended use .16
5.5 Retirement phase .16
6 Documentation .16
7 Prerequisite processes .17
Annex A (informative) Toolbox.18
Annex B (informative) Risk management and risk-based approach .24
Annex C (informative) Examples .28
Bibliography .84
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
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 should 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).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on 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 the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices, in collaboration with Technical Committee IEC/TC 62,
Electrical equipment in medical practice, Subcommittee SC 62A, Common aspects of electrical equipment
used in medical practice, in accordance with ISO/IEC mode of cooperation 4.
A list of all parts in the ISO 80002 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

Introduction
This document has been developed to assist readers in determining appropriate activities for the
validation of process software used in medical device quality systems using a risk-based approach that
applies critical thinking.
This includes software used in the quality management system, software used in production and
service provision, and software used for the monitoring and measurement of requirements, as required
by ISO 13485:2016: 4.1.6, 7.5.6 and 7.6.
This document is the result of an effort to bring together experience from medical device industry
personnel who deal with performing this type of software validation and who are tasked with
establishing auditable documentation. The document has been developed with certain questions and
problems in mind that we all go through when faced with validating process software used in medical
device quality systems such as the following: What has to be done? How much is enough? How is risk
analysis involved? After much discussion, it has been concluded that in every case, a set of activities (i.e.
the tools from a toolbox) was identified to provide a level of confidence in the ability of the software
to perform according to its intended use. However, the list of activities varied depending on factors
including, among others, the complexity of the software, the risk of harm involved and the pedigree
(e.g. quality, stability) of vendor-supplied software.
The intention of this document is to help stakeholders, including manufacturers, auditors and regulators,
to understand and apply the requirement for validation of software included in ISO 13485:2016, 4.1.6,
7.5.6 and 7.6.
TECHNICAL REPORT ISO/TR 80002-2:2017(E)
Medical device software —
Part 2:
Validation of software for medical device quality systems
1 Scope
This document applies to any software used in device design, testing, component acceptance,
manufacturing, labelling, packaging, distribution and complaint handling or to automate any other
aspect of a medical device quality system as described in ISO 13485.
This document applies to
— software used in the quality management system,
— software used in production and service provision, and
— software used for the monitoring and measurement of requirements.
It does not apply to
— software used as a component, part or accessory of a medical device, or
— software that is itself a medical device.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000 and ISO 13485 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
4 Software validation discussion
4.1 Definition
The term “software validation” has been interpreted both broadly and narrowly, from just testing to
extensive activities including testing. This document uses the term software validation to denote all
of the activities that establish a level of confidence that the software is appropriate for its intended use
and that it is trustworthy and reliable. The chosen activities, whatever they might be, should ensure
that the software meets its requirements and intended purpose.
4.2 Confidence-building activities: Tools in the toolbox
The tools in the toolbox (see Table A.1 to Table A.5) include activities completed during the life cycle of
software that reduce risk and build confidence.
4.3 Critical thinking
This document promotes the use of critical thinking to determine which activities should be performed
to adequately validate specific software. Critical thinking is a process of analysing and evaluating
various aspects of software, as well as the environment in which it will be used, to identify the most
meaningful set of confidence-building activities to be applied during validation. Critical thinking
avoids an approach that applies a one-size-fits-all validation solution without thoroughly evaluating
the solution to determine if it indeed results in the desired outcome. Critical thinking recognizes that
validation solutions can vary greatly from software to software and also allows for different validation
solutions to be applied to the same software in a similar situation. Critical thinking challenges
proposed validation solutions, to ensure that they meet the intent of the quality management system
requirements, and considers all key stakeholders and their needs. Critical thinking is also used to re-
evaluate the validation solution when characteristics of the software change, when the software’s
intended use changes or when new information becomes available.
Critical thinking results in a validation solution that establishes compliance for a manufacturer,
ensures t
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