ISO DGUIDE 63

Description / Abstract: This sectorial Guide provides requirements and recommendations for the writers of medical device standards for including aspects related to safety in those standards. These requirements and recommendations are based on well-established risk management concepts and methodology. Therefore, it is applicable to any aspect related to the safety of people, property, the environment, or to a combination of these.

In this guide, the term product includes a medical device or a system consisting of one or more medical device(s) possibly combined with non-medical devices.