Standard

ISO/IEC Guide 63:2012

Jan 2012 Withdrawn

Note: Latest version: ISO/IEC Guide 63:2019

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Abstract

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.

Products specifications

Standard from ISO/IEC
Published: January 10 2012
Withdrawn: August 12 2019
Period for objection until: December 22 2010
Edition: 2
Document type: GUIDE
Pages
ISBN:

Publisher: ISO/IEC
Distributor: ISO/IEC
ICS: 11.020.01
International TC: ISO/TMBG

Product Relations

Revised by: ISO/IEC Guide 63:2019
Revises: ISO/IEC Guide 63:1999
Joinded work item: IEC, 0

ISO/IEC Guide 63:2012

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ISO/IEC Guide 63:2019