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ISO/IEC Guide 63:2012

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

Jan 10, 2012
95.99   Withdrawal of Standard   Aug 12, 2019

General information

95.99     Aug 12, 2019

ISO/IEC

ISO/TMBG

Guide

11.020.01  

English  

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Scope

ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.
ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/IEC Guide 63:1999

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WITHDRAWN
ISO/IEC Guide 63:2012
95.99 Withdrawal of Standard
Aug 12, 2019

REVISED BY

PUBLISHED
ISO/IEC Guide 63:2019