National foreword

This Published Document is the UK implementation of ISO/TR 8000‑2:2017.

The UK participation in its preparation was entrusted to Technical Committee CH/62/1, Common aspects of Electrical Equipment used in Medical Practice.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 October 2017.

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: www.iso.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.

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.

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

3 Terms and definitions

4 Software validation discussion

4.1 Definition

4.2 Confidence-building activities: Tools in the toolbox

4.3 Critical thinking

5 Software validation and critical thinking

5.1 Overview

5.2 Determine if the software is in scope

5.3 Development phase

5.4 Maintain phase

5.5 Retirement phase

6 Documentation

7 Prerequisite processes

Bibliography

PD ISO/TR 80002-2:2017

Medical device software - Validation of software for medical device quality systems

Current

Published:

31 Oct 2017