DS/ISO/IEC Guide 63
Guide to the development and inclusion of safety aspects in International Standards for medical devices
inactive
| Organization: | DS |
| Publication Date: | 17 February 2012 |
| Status: | inactive |
| Page Count: | 30 |
| 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 standard 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/IECGuide 51 to include safety-related performance and usability.
Document History
August 19, 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...
DS/ISO/IEC Guide 63
February 17, 2012
Guide to the development and inclusion of safety aspects in International Standards for medical devices
This Guide provides guidance to standard writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework...