Standard

ISO/IEC Guide 63:2019

Aug 2019 Current

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Language English

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Abstract

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.

Products specifications

Standard from ISO/IEC
Published: August 12 2019
Edition: 3
Document type: GUIDE
Pages
ISBN:

Publisher: ISO/IEC
Distributor: ISO/IEC
ICS: 01.120
ICS: 11.040.01
International TC: ISO/TMBG

Product Relations

Revises: ISO/IEC Guide 63:2012
Joinded work item: IEC, 0

Product life cycle

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ISO/IEC Guide 63:2012
Current product

Current

ISO/IEC Guide 63:2019
Stage 90.20

ISO/IEC Guide 63:2019

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