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ISO/IEC GUIDE 63:2012

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

Standard Details

ISO/IEC Guide 63:2012 provides guidance to StandardDetails writers on how to include safety aspects in the development of medical device safety StandardDetails 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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO/IEC GUIDE 63:2012
Document Year: 2012
Pages: 21
Edition: 2.0
  • ICS:
  • 01.120 Standardization. General rules
  • 11.020 Medical sciences and health care facilities in general

Life Cycle

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WITHDRAWN
ISO/IEC GUIDE 63:2012
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