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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 1999
Status: inactive
Page Count: 14
ICS Code (Medical sciences and health care facilities in general): 11.020
ICS Code (Standardization. General rules): 01.120
scope:

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 medical need for the device and the use of standards in medical device design, manufacture and regulation.

This Guide will also help those who use medical device standards to understand what such standards are intended to accomplish. Among such users are:

- users of medical devices;

- hospital administrators;

- personnel involved in the procurement of medical devices;

- regulatory authorities;

- persons responsible for the design and construction of patient care facilities;

- persons responsible for the installation and maintenance of medical devices;

- manufacturers of medical devices;

- persons who assemble systems of medical devices from more than one manufacturer.

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

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...
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...
ISO/IEC GUIDE 63
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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