GB/T 42062-2022
Medical devices—Application of risk management to medical devices (English Version)

Standard No.

GB/T 42062-2022

Language

Chinese, Available in English version

Release Date

2022

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB/T 42062-2022

Scope

This document specifies the terms, principles and processes for risk management of medical devices (including software as medical devices and in vitro diagnostic medical devices). The process described in this document is intended to help medical device manufacturers identify hazards associated with medical devices, estimate and evaluate associated risks, control these risks and monitor the effectiveness of controls. The requirements of this document apply to all stages of the medical device life cycle. The process described in this document applies to risks associated with medical devices, such as risks related to biocompatibility, information security of data and systems, electricity, moving parts, radiation and usability. The processes described in this document are also applicable to products that are non-medical devices in some jurisdictions and can be used by other parties involved in the medical device lifecycle. This document does not apply to: — decisions to use medical devices in the context of any specific clinical procedure; — commercial risk management. This document requires manufacturers to establish objective risk acceptability criteria, but this document does not prescribe acceptable levels of risk. Risk management can be an integral part of the quality management system. However, this document does not require manufacturers to have an established quality management system. Note: See YY/T 1437 [10] for the guidance of this document. As stated in the introduction to this document, a risk management standard that applies to the lifecycle of medical devices is needed. Software and in vitro diagnostic medical devices as medical devices are specifically mentioned in the scope to avoid any possible exclusion from this document due to different regulations. 15 GB/T 42062—2022/ISO 14971:2019 2 Terms and definitions

GB/T 42062-2022 history

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