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ISO/IEC Guide 63:2019

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

Standard Details

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.

General Information

Status : Published
Standard Type: Main
Document No: ISO/IEC Guide 63:2019
Document Year: 2019
Pages: 26
Edition: 3
  • ICS:
  • 01.120 Standardization. General rules
  • 11.040.01 Medical equipment in general

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ISO/IEC Guide 63:2019
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