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ISO/IEC GUIDE 63

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

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Organization: ISO
Publication Date: 1 January 2012
Status: inactive
Page Count: 28
ICS Code (Medical sciences and health care facilities in general): 11.020
ICS Code (Standardization. General rules): 01.120
scope:

This Guide 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.

This Guide is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

Document History

August 1, 2019
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
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...
ISO/IEC GUIDE 63
January 1, 2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
This Guide 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...
January 1, 1999
Guide to the Development and Inclusion of Safety Aspects in International Standards for Medical Devices
This Guide provides an approach to writing international standards for medical devices that takes into account the hazards of medical use, the role of standards in managing risk in relation to the...

References

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