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Publication detail

 
Reference ISO/IEC GUIDE 63 ed2.0 withdrawn corrigendum
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Title Guide to the development and inclusion of safety aspects in International Standards for medical devices
Publication date 2012-01-10
Format, price
(Swiss francs)
and language
118.- 21 pages
118.- 544 Kb
 
Abstract ISO/IEC Guide 63:2012 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.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.
Technical Committee ISO/TC 210 -   RSS
ICS Codes
01.120 Standardization. General rules
*Including rules for the preparation of standards catalogues and management of technical documents

11.020 Medical sciences and health care facilities in general
*Including quality and environmental management in health care technology
*IT application in health care technology, see 35.240.80
 
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