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GB/T 42062-2022 English PDF (GBT42062-2022)

GB/T 42062-2022 English PDF (GBT42062-2022)

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

GB/T 42062-2022
ICS 11.040.01
CCS C 30
GB/T 42062-2022 / ISO 14971:2019
Medical Devices – Application of Risk Management to
Medical Devices
(ISO 14971:2019, IDT)
Issued by: State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 4
Introduction ... 5
1 Scope ... 7
2 Normative References ... 7
3 Terms and Definitions ... 8
4 General Requirements for Risk Management System ... 15
4.1 Risk management process ... 15
4.2 Management responsibilities ... 17
4.3 Competence of personnel ... 18
4.4 Risk management plan ... 18
4.5 Risk management file ... 19
5 Risk Analysis ... 20
5.1 Risk analysis process ... 20
5.2 Intended use and reasonably foreseeable misuse ... 21
5.3 Identification of characteristics related to safety ... 21
5.4 Identification of hazards and hazardous situations ... 21
5.5 Risk estimation ... 22
6 Risk Evaluation ... 23
7 Risk Control ... 23
7.1 Risk control option analysis ... 23
7.2 Implementation of risk control measures ... 24
7.3 Residual risk evaluation ... 25
7.4 Benefit-risk analysis ... 25
7.5 Risks arising from risk control measures ... 25
7.6 Completeness of risk control ... 26
8 Evaluation of Overall Residual Risk ... 26
9 Risk Management Review ... 26
10 Production and Post-Production Activities ... 27
10.1 General ... 27
10.2 Information collection ... 27
10.3 Information review ... 28
10.4 Actions ... 28
Annex A (Informative) Rationale for Requirements ... 30
Annex B (Informative) Risk Management Process for Medical Devices ... 42 Annex C (Informative) Fundamental Risk Concepts ... 46
Bibliography ... 52
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1: Rules for the Structure and Drafting of Standardizing Documents. This Document equivalently adopts ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices.
Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Document was proposed by National Medical Products Administration. This Document shall be under the jurisdiction of National Technical Committee on Quality Management and General Requirements for Medical Device of Standardization Administration of China (SAC/TC 221).
Drafting organizations of this Document: Beijing Hua Guang Certification of Medical Devices Co., Ltd.; National Institutes for Food and Drug Control; Neusoft Medical Systems Co., Ltd.; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Shanghai MicroPort Medical (Group) Co., Ltd.; Shanghai United Imaging Healthcare Co., Ltd.; Shandong Weigao Group Medical Polymer Co., Ltd.; Contec Medical Systems Co., Ltd.; GE Hangwei Medical Systems Co., Ltd.; Shanghai Siemens Medical Equipment Ltd.; and Lepu Medical Technology (Beijing) Co., Ltd. Chief drafting staffs of this Document: Wang Huifang, Sun Ye, Zheng Jia, Wang Zhiqiang, Wang Hongman, Li Yong, Wang Shumei, Liu Lina, Li Xueyong, Han Qiang, Lu Zhi, Jiang Bo, Li Haohui, Wang Meiying, Lou Xiaodong, Li Xin, Chang Jia, Liu Rongming, Shao Yubo, Wang Tingting, and Ai Yingying.
Medical Devices – Application of Risk Management to
Medical Devices
1 Scope
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability.
The process described in this document can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device life cycle.
This document does not apply to:
— decisions on the use of a medical device in the context of any particular clinical procedure; or
— business risk management.
This document requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels.
Risk management can be an integral part of a quality management system. However, this document does not require the manufacturer to have a quality management system in place. NOTE: Guidance on the application of this document can be found in YY/T 1437 [10]. 2 Normative References
There are no normative references in this Document.
Compliance is checked by inspection of the risk management file.
7.6 Completeness of risk control
The manufacturer shall review the risk control activities to ensure that the risks from all identified hazardous situations have been considered and all risk control activities are completed.
The results of this review shall be recorded in the risk management file. Compliance is checked by inspection of the risk management file.
8 Evaluation of Overall Residual Risk
After all risk control measures have been implemented and verified, the manufacturer shall evaluate the overall residual risk posed by the medical device, taking into account the contributions of all residual risks, in relation to the benefits of the intended use, using the method and the criteria for acceptability of the overall residual risk defined in the risk management plan [see 4.4 e)].
If the overall residual risk is judged acceptable, the manufacturer shall inform users of significant residual risks and shall include the necessary information in the accompanying documentation in order to disclose those residual risks.
NOTE 1: The rationale for the disclosure of significant residual risks is given in A.2.8. NOTE 2: See YY/T 1437 [10]for guidance on the evaluation of overall residual risk and the disclosure of residual risks.
If the overall residual risk is not judged acceptable in relation to the benefits of the intended use, the manufacturer may consider implementing additional risk control measures (go back to 7.1) or modifying the medical device or its intended use (go back to 5.2). Otherwise, the overall residual risk remains unacceptable.
The results of the evaluation of the overall residual risk shall be recorded in the risk management file.
Compliance is checked by inspection of the risk management file and the accompanying documentation.
9 Risk Management Review
Prior to release for commercial distribution of the medical device, the manufacturer shall review the execution of the risk management plan. This review shall at least ensure that:

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