BS PD ISO/IEC GUIDE 63:2019

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.