GB/T 42062-2022 PDF English
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GB/T 42062-2022: Medical devices - Application of risk management to medical devices---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT42062-2022
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
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 on. OCTOBER 12, 2022
Implemented on. NOVEMBER 01, 2023
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
Foreword
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.
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.
2 Normative References
There are no normative references in this Document.
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following
addresses.
4 General Requirements for Risk Management System
Top management shall provide evidence of its commitment to the risk management process by
ensuring.
Risk management activities shall be planned. For the particular medical device being
considered, the manufacturer shall establish and document a risk management plan in
accordance with the risk management process. The risk management plan shall be part of the
risk management file.
5 Risk Analysis
The manufacturer shall document the intended use of the particular medical device being
considered.
For the particular medical device being considered, the manufacturer shall identify and
document those qualitative and quantitative characteristics that could affect the safety of the
medical device. Where appropriate, the manufacturer shall define limits of those characteristics.
6 Risk Evaluation
For each identified hazardous situation, the manufacturer shall evaluate the estimated risks and
determine if the risk is acceptable or not, using the criteria for risk acceptability defined in the
risk management plan.
7 Risk Control
The manufacturer shall implement the risk control measures selected in 7.1.
Implementation of each risk control measure shall be verified. This verification shall be
recorded in 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)].
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.
10 Production and Post-Production Activities
The manufacturer shall review the information collected for possible relevance to safety,
especially whether.
Annex A
(Informative)
Rationale for Requirements
The ISO/TC 210 - IEC/SC 62A Joint Working Group 1 (JWG 1), Application of risk
management to medical devices, developed this rationale to document its reasoning for
establishing the various requirements contained in this document.
The second edition of ISO 14971 was developed and published in 2007 to address the need for
additional guidance on its application and on the relationship between hazards and hazardous
situations.
Annex B
(Informative)
Risk Management Process for Medical Devices
The numbering of clauses and subclauses has changed with this third edition of this Document.
Table B.1 provides the correspondence between clauses and subclauses in the YY/T 0316-2016
[9] and those in this Document.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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