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 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