ISO/TR 80002-2:2017 医療機器ソフトウェア—パート2：医療機器品質システムのソフトウェアの妥当性確認 | ページ 2

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, 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, 2 (see www.iso.org/directives ).

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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

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:

Bibliography