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BS PD ISO/IEC GUIDE 63:2019

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

standard by BSI Group , 08/21/2019

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About This Item

 

Full Description

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 management concepts and methodology.

This document is applicable to any aspect related to the safety of people, property, the environment, or a combination of these.

In this document, the term "product" includes a medical device or a system consisting of one or more medical devices, possibly combined with non-medical devices.

Cross References:
IEC 62304
ISO 13485
IEC 60417
ISO/TR 24971
ISO 14971
IEC Guide 109
ISO 11137-1
ISO 11135
ISO/IEC Guide 37
ISO 3864
ISO 7010
ISO 7001
ISO 10993
ISO 15223-1
ISO/TR 80002-1
ISO 7000
ISO/IEC Guide 14
ISO/IEC Guide 41
IEC 82079-1
ISO 9000:2015
ISO/IEC Guide 51:2014
IEC 80001-1:2010
ISO/IEC GUIDE 2:2004


All current amendments available at time of purchase are included with the purchase of this document.
 

Product Details

Published:
08/21/2019
ISBN(s):
9780539037098
Number of Pages:
38
File Size:
1 file , 1.6 MB
Product Code(s):
30390373, 30390373, 30390373
Note:
This product is unavailable in Ukraine, Russia, Belarus