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ISO/IEC GUIDE 63

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

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Organization: ISO
Publication Date: 1 August 2019
Status: active
Page Count: 36
ICS Code (Standardization. General rules): 01.120
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

ISO/IEC GUIDE 63
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...
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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