This document provides standards writers with requirements and recommendations for incorporating safety-related content into medical device standards. These requirements and recommendations are based on established risk management concepts and methods. This document applies to the safety-related content of personnel, property, environment or a combination of these factors involved in medical device standards. In this document, the term "product" includes a single medical device or a system consisting of one or more medical devices (which may also be combined with non-medical devices).
YY/T 1473-2023 history
2023YY/T 1473-2023 Medical device standardization work guide involves standard formulation of safety content
2016YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices