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