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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

21-08-2019

Publisher

British Standards Institution

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.

Committee	CH/210/4
DocumentType	Standard
ISBN	9780539037098
Pages	38
ProductNote	This standard also refers to IEC 60417,ISO 10993,ISO/TR 80002-1.
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
ISO/IEC Guide 63:2019	Identical

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PD ISO/IEC GUIDE 63:2019

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

Abstract

Scope

General Product Information

International Equivalents

Category

Subcategory