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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

BSI Group , 08/21/2019

Publisher: BS

File Format: PDF

$154.00$309.88


Standard By:BSI Group , 08/21/2019
Published:08/21/2019
Pages:38
ISBN(s):9780539037098
File Size:1 file , 1.6 MB
Language:English
Note:This product is unavailable in Ukraine, Russia, Belarus
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 62304ISO 13485IEC 60417ISO/TR 24971ISO 14971 IEC Guide 109ISO 11137-1ISO 11135ISO/IEC Guide 37ISO 3864ISO 7010ISO 7001ISO 10993ISO 15223-1ISO/TR 80002-1ISO 7000ISO/IEC Guide 14ISO/IEC Guide 41IEC 82079-1ISO 9000:2015ISO/IEC Guide 51:2014IEC 80001-1:2010ISO/IEC GUIDE 2:2004

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