GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Scope

This document specifies the terminology, principles, and processes of risk management for medical devices (including software and in vitro diagnostic medical devices as medical devices). The processes described in this document aim to assist medical device manufacturers in identifying hazards associated with medical devices, estimating and evaluating related risks, controlling these risks, and monitoring the effectiveness of the controls. The requirements of this document apply to all stages of the life cycle of medical devices. The processes described in this document apply to risks associated with medical devices, such as those related to biocompatibility, information security of data and systems, electricity, moving parts, radiation, and usability. The processes described in this document also apply to products that are classified as non-medical devices in certain jurisdictions and can be used by other parties involved in the life cycle of medical devices. This document does not apply to: -- the decision to use medical devices in any specific clinical procedure; -- commercial risk management. This document requires manufacturers to establish objective risk acceptability criteria, but it does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this document does not require manufacturers to have an established quality management system. Note: Guidelines for this document can be found in YY/T 1437 [10].

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