YY/T 1437-2023
Medical Device GB/T 42062 Application Guide (English Version)
- Standard No.
- YY/T 1437-2023
- Language
- Chinese, Available in English version
- Release Date
- 2024
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1437-2023
- Replace
- YY/T 1437-2016
- Scope
- This document provides guidance on developing, implementing and maintaining a medical device risk management system in accordance with GB/T 42062-2022. The risk management process can be an integral part of a quality management system (such as a system based on GB/T 42061-2022), but there is no such requirement in GB/T 42062-2022. Certain requirements related to risk management in GB/T 42061-2022 (Chapter 7 "Product Realization" and 8.2.1 "Feedback") can be achieved by applying GB/T 42062-2022, see YY/T 0595- 2020.
YY/T 1437-2023 history
- 2024 YY/T 1437-2023 Medical Device GB/T 42062 Application Guide
- 2016 YY/T 1437-2016 Medical devices.Guidance on the applicantion of ISO 14971
