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GB/T 42062-2022: Medical devices - Application of risk management to medical devices
GB/T 42062-2022
Medical devices - Application of risk management to medical devices
ICS 11.040.01
CCSC30
National Standards of People's Republic of China
Application of medical device risk management to medical devices
(ISO 14971.2019, IDT)
Released on 2022-10-12
2023-11-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 General requirements for risk management system 6
4.1 Risk management process 6
4.2 Management Responsibilities 7
4.3 Personnel Competence8
4.4 Risk Management Plan 8
4.5 Risk Management Documentation 8
5 Risk Analysis 9
5.1 Risk Analysis Process 9
5.2 Intended use and reasonably foreseeable misuse9
5.3 Identification of safety-related characteristics9
5.4 Identification of hazards and hazardous situations9
5.5 Risk Estimation 10
6 Risk assessment10
7 Risk Control 11
7.1 Risk control plan analysis 11
7.2 Implementation of risk control measures 11
7.3 Residual risk assessment 11
7.4 Benefit-risk analysis 11
7.5 Risks arising from risk control measures 12
7.6 Integrity of risk controls 12
8 Comprehensive residual risk assessment 12
9 Risk Management Review 12
10 Production and post-production activities 13
10.1 General 13
10.2 Information Collection 13
10.3 Information review 13
10.4 Measure 13
Appendix A (informative) Explanation of various requirements 15
Appendix B (Informative) Medical Device Risk Management Process 23
Appendix C (Informative) Basic Risk Concepts 27
Reference 32
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is equivalent to ISO 14971.2019 "Application of Medical Device Risk Management to Medical Devices".
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221).
This document was drafted by. Beijing Guoyi Machinery Huaguang Certification Co., Ltd., China Institute for Food and Drug Control, Neusoft Medical System Co., Ltd.
Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd., Shanghai United Imaging Medical Technology
Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Kangtai Medical System (Qinhuangdao) Co., Ltd., Hang
Wei General Electric Medical System Co., Ltd., Shanghai Siemens Medical Devices Co., Ltd., and Lepu (Beijing) Medical Devices Co., Ltd.
The main drafters 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 Zhaohui, Wang Meiying, Lou Xiaodong, Li Xin, Chang Jia, Liu Rongmin, Shao Yubo, Wang Tingting, Ai Yingying.
introduction
The requirements contained in this document provide manufacturers with a systematic application of experience, knowledge and judgment to manage
related risk framework.
This document is based on established risk management principles that have been progressively developed over the years and has been developed specifically for medical device manufacturers. for a certain
For other products that are not medical devices in these jurisdictions, as well as suppliers and other parties involved in the life cycle of medical devices, this document can
To be used as a guide for developing and maintaining a risk management process.
This document deals with the risk management process associated with medical devices. Risks may not only be related to injury to the patient, but also to the user
related to injury to other persons and possibly to property (e.g. items, data, other equipment) or to the environment.
Because each stakeholder has a different judgment on the acceptability of risks associated with expected benefits, risk management is a
a complex subject. Due to the diversity of stakeholders, including healthcare workers, organizations providing healthcare, government, industry, patients and
The public, therefore the concept of risk management is particularly important for medical devices.
It is generally accepted that the concept of risk has two key components.
--- Probability of occurrence of injury;
---The consequences of the injury, that is, the possible severity.
All stakeholders need to understand that even when risks have been reduced to an acceptable level, there must be some degree of
risks of. It is well known that some residual risks still exist in clinical procedures. The acceptability of risk by each stakeholder is governed by the
Key components and their perceived impact on risks and benefits. The perception of each stakeholder is influenced by its cultural background, the social
There may be differences due to the influence of economic and educational background, actual and perceived patient health status. The way you perceive risk also takes into account its
Other factors, for example, whether the exposure to a hazard or hazardous situation is unintentional, avoidable, deliberate, due to inattention, caused by insufficient cognitive
cause, or whether it is targeting a vulnerable group in society. As one of the stakeholders, the manufacturer reduces risks and determines the safety of medical devices.
fully encompass the acceptability of residual risk. The manufacturer considers the generally accepted state of the art in order to determine that the medical device is suitable for its intended use.
Suitability for listing. This document specifies a process by which a medical device manufacturer can
Identify hazards associated with medical devices, estimate and evaluate risks associated with those hazards, control those risks and monitor the effectiveness of controls.
The decision to use a medical device in the context of a specific clinical procedure requires weighing the remaining risks against the expected benefits of the clinical procedure. The decision exceeds
Beyond the scope of this document, consideration should be given to the intended use, environment of use, performance and risks associated with the medical device, as well as the clinical procedures associated with it.
Risks and Benefits. Only a qualified medical practitioner with knowledge of the patient's personal health condition or the patient's personal opinion should make either
some decisions.
For any particular medical device, other standards or regulations may require the application of specific approaches to manage risk. In these cases, also
The requirements stated in these documents need to be followed.
To facilitate the understanding and use of this document by manufacturers, regulatory agencies, healthcare providers and other stakeholders, Appendix A provides
Description of specific section, clause requirements.
All previous editions of ISO 14971 have been transformed into YY/T 0316, see B.1 for the corresponding relationship between YY/T 0316-2016[9] and this document.
The form of verbs in this document conforms to the usage described in GB/T 1.1-2020.In this document, auxiliary verbs.
--- "Should" means that in order to comply with this document, compliance with requirements or testing is mandatory;
--- "Should" means that in order to comply with this document, compliance with requirements or testing is recommended rather than mandatory;
--- "May" is used to describe permission (for example, a permissible way to achieve compliance with requirements or tests);
--- "may/can" is used to express possibility/ability;
--- "Must" is used to indicate external constraints that are not required by this document.
Application of medical device risk management to medical devices
1 Scope
This document specifies the terms, principles and principles of risk management for medical devices (including software as medical devices and in vitro diagnostic medical devices).
process. The process described in this document is intended to assist medical device manufacturers in identifying, estimating and evaluating the associated hazards associated with medical devices.
risks, controlling those risks and monitoring 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 medical device-related
Risks, such as those related to biocompatibility, information security of data and systems, electricity, moving parts, radiation and availability.
The process described in this document is also applicable to products that are non-medical devices in some jurisdictions and can also be used in the medical device life cycle.
used by other parties involved.
This document does not apply to.
--- the decision to use the medical device in any specific clinical procedure;
---Business 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 established quality management
system.
Note. See YY/T 1437 [10] for the guidance of this document.
2 Normative references
This document has no normative references.
3 Terms and Definitions
The following terms and definitions apply to this document.
The addresses of terminology databases maintained by ISO and IEC for standardization are as follows.
3.1
The documents attached to the medical device (3.10) include instructions for the user or responsible for the installation, use, maintenance, and final discontinuation of the medical device (3.10).
Information provided by persons using and disposing of the product, especially regarding safe use.
Note 1.Accompanying documents may include instructions for use, technical descriptions, installation manuals, and quick reference guides.
Note 2.Accompanying documents are not necessarily written or printed documents, but may involve auditory, visual or tactile information and multiple media types.
3.2
benefit benefit
positive effect or desired outcome of the use of a medical device (3.10) on individual health, or positive effect on patient management or public health
NOTE. Benefits may include positive effects on clinical outcomes, patient quality of life, diagnosis-related outcomes, and positive clinical outcomes from diagnostic devices