Standard Number: YY/T 1437-2023(YY/T1437-2023)
Chinese:医疗器械 GB/T 42062应用指南
English:Medical devices-Guidance on the application of GB/T 42062
Effective Date:2024-07-01
ICS:11.040.01
Standard Applicability:This document provides guidance for developing, implementing and maintaining a medical device risk management system in accordance with GB/T 42062-2022. The risk management process may be an integral part of a quality management system (e.g., a system based on GB/T 42061-2022), but there is no requirement for this in GB/T 42062-2022.Some of the requirements of GB/T 42061-2022 that are relevant to risk management (Chapters 7, “Product Realization” and 8.2.1, “Feedback”) can be addressed through the application of GB/T 42062-2022. 8.2.1 “Feedback”) can be realized by applying GB/T 42062-2022, see YY/T 0595-2020.
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