ISO/IEC GUIDE 63:2012

Title

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

Abstract

Language: EN 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.

Language(s)
Language: RU
Edition
2.0
Date of issue
10.01.2012
ISO/TC 210
ICS Codes
01.120, 11.020
Publication number
63
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Price (excl. VAT)
€ 107,30 (Download and hardcopy)
Delivery format
postal download (21 Pages)

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