ISO/IEC GUIDE 63:2012 Withdrawn

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

CHF 

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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.

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Additional information

Publication typeGuide
Publication date2012-01-10
Withdrawal date2019-08-12
Edition2.0
Available language(s)English, Russian
TC/SCISO/TC 210 - Quality management and corresponding general aspects for medical devicesrss
ICS01.120 - Standardization. General rules
11.020 - Medical sciences and health care facilities in general
Stability date  2019
Pages21
File size580 KB

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