This sectorial Guide provides requirements and recommendations for the writers of medical device standards 6 for including aspects related to safety in those standards. These requirements and recommendations are 7 based on well-established risk management concepts and methodology. Therefore, it is applicable to any 8 aspect related to the safety of people, property, the environment, or to a combination of these. 9 In this guide, the term product includes a medical device or a system consisting of one or more medical 10 device(s) possibly combined with non-medical devices.
Antal sider: 34
Internationale relationer: ISO/IEC PRF Guide 63 IDT