YY/T 1437-2023 PDF English
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Medical devices - Guidance on the application of GB/T 42062
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Medical devices--Guidance on the applicantion of ISO 14971
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YY/T 1437-2023: Medical devices - Guidance on the application of GB/T 42062---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/YYT1437-2023
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.01
CCS C 30
YY/T 1437-2023 / ISO/TR 24971.2020
Replacing YY/T 1437-2016
Medical devices - Guidance on the application of GB/T
(ISO/TR 24971.2020, Medical devices - Guidance on the application of ISO
14971, IDT)
Issued on. JUNE 20, 2023
Implemented on. JULY 01, 2024
Issued by. National Medical Products Administration
Table of Contents
Foreword... 4
Introduction... 6
1 Scope... 7
2 Normative references... 7
3 Terms and definitions... 7
4 General requirements for risk management system... 7
4.1 Risk management process... 7
4.2 Management responsibilities... 8
4.3 Competence of personnel... 9
4.4 Risk management plan... 10
4.5 Risk management file... 13
5 Risk analysis... 14
5.1 Risk analysis process... 14
5.2 Intended use and reasonably foreseeable misuse... 14
5.3 Identification of characteristics related to safety... 15
5.4 Identification of hazards and hazardous situations... 15
5.5 Risk estimation... 20
6 Risk evaluation... 25
7 Risk control... 26
7.1 Risk control option analysis... 26
7.2 Implementation of risk control measures... 29
7.3 Residual risk evaluation... 30
7.4 Benefit-risk analysis... 30
7.5 Risks arising from risk control measures... 34
7.6 Completeness of risk control... 34
8 Evaluation of overall residual risk... 34
8.1 General considerations... 34
8.2 Inputs and other considerations... 35
8.3 Possible approaches... 37
9 Risk management review... 38
10 Production and post-production activities... 38
10.1 General... 38
10.2 Information collection... 39
10.3 Information review... 40
10.4 Actions... 42
Annex A (Informative) Identification of hazards and characteristics related to safety44
Annex B (Informative) Techniques that support risk analysis... 54
Annex C (Informative) Relation between the policy, criteria for risk acceptability, risk
control and risk evaluation... 60
Annex D (Informative) Information for safety and information on residual risk... 66
Annex E (Informative) Role of standards in risk management... 69
Annex F (Informative) Guidance on risks related to security... 75
Annex G (Informative) Components and devices designed without using ISO 14971
... 80
Annex H (Informative) Guidance for in vitro diagnostic medical devices... 83
Bibliography... 115
Foreword
This document was drafted in accordance with the rules provided in GB/T 1.1-2020
Directives for standardization - Part 1.Rules for the structure and drafting of
standardizing documents.
This document replaces YY/T 1437-2016, Medical devices - Guidance on the
application of YY/T 0316.Compared with YY/T 1437-2016, in addition to structural
adjustments and editorial changes, the main technical changes are as follows.
-- Change the scope of the document (see Clause 1; Clause 1 of the 2016 edition);
-- Add the clause “Terms and definitions” (see Clause 3);
-- Add the clause “General requirements for risk management system” (see Clause 4);
-- Add the clause “Risk analysis” (see Clause 5);
-- Add the clause “Risk evaluation” (see Clause 6);
-- Add the clause “Risk control” (see Clause 7);
-- Change “General considerations” to “General”, and include the relevant contents of
the 2016 edition changed (see 8.1; 6.1 of the 2016 edition); change “inputs and other
considerations of evaluation of overall residual risk” to “inputs and other
considerations”, and include the relevant contents of the 2016 edition (see 8.2; 6.2
of the 2016 edition); add “possible approaches” (see 8.3);
-- Add the clause “Risk management review” (see Clause 9);
-- Change “production and post-production feedback loop” to “Production and post-
production activities”, and add relevant contents (see Clause 10; Clause 4 of the 2016
edition);
-- Add “Identification of hazards and characteristics related to safety” (see Annex A);
-- Add “Techniques that support risk analysis” (see Annex B);
-- Add “Relation between the policy, criteria for risk acceptability, risk control and risk
evaluation”, and include the relevant contents of the 2016 edition (see Annex C;
Clause 3 of the 2016 edition);
-- Add “Information for safety and information on residual risk”, and include the
relevant contents of the 2016 edition (see Annex D; Clause 5 of the 2016 edition);
-- Add “Role of standards in risk management”, and include the relevant contents of the
2016 edition (see Annex E; Clause 2 of the 2016 edition);
-- Add “Guidance on risks related to security” (see Annex F);
-- Add “Components and devices designed without using ISO 14971” (see Annex G);
-- Add “Guidance for in vitro diagnostic medical devices” (see Annex H).
This document is equivalent to ISO/TR 24971.2020 Medical devices - Guidance on the
application of ISO 14791, while the document type is adjusted from an ISO technical
report to an industry standard of our country.
Please note that some of the contents of this document may involve patents. The issuing
organization of this document is not responsible for identifying patents.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Quality Systems and Corresponding General Aspects for Medical Devices of
Standardization Administration of China (SAC/TC 221).
Drafting organizations of this document. Beijing Guoyi Huaguang Authentication Co.,
Ltd., China Institute of Food and Drug test, Shenzhen Mindray Bio-Medical Electronics
Co., Ltd., Neusoft Medical Systems Co., Ltd., Shanghai MicroPort Medical (Group)
Co., Ltd., GE Hangwei Medical Systems Company Ltd., CONTEC Medical Systems
Co., Ltd., Shanghai United Imaging Healthcare Co., Ltd., Shandong Weigao Group
Medical Polymer Company Limited., Siemens Shanghai Medical Equipment Ltd., Lepu
Medical Technology (Beijing) Co., Ltd.
Main drafters of this document. Lou Xiaodong, Wang Huifang, Xu Huiwen, Wang
Hongman, Wang Zhiqiang, Li Yong, Han Qiang, Li Xueyong, Li Rong, Liu Lina, Lu
Zhi, Jiang Bo, Li Zhaohui, Sun Ye, Li Xin, Chang Jia, Liu Rongmin, Shao Yubo, Wang
Tingting, Ai Yingying.
The previous versions of this document and the documents which are replaced by this
document are as follows.
-- It was issued for the first time in 2016 as YY/T 1437-2016;
-- This is the first revision.
1 Scope
This document provides guidance on the development, implementation and
maintenance of a risk management system for medical devices according to GB/T
42062-2022.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only the
edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
GB/T 42062-2022, Medical devices - Application of risk management to medical
devices (ISO 14971.2019, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 42062-2022
apply.
4 General requirements for risk management system
GB/T 42062-2022 requires top management to review the suitability of the risk
management process at planned intervals. The review of the suitability is a high-level
review of the risk management process and can include reviewing the following aspects,
for example.
5 Risk analysis
A hazard is a potential source of a harm. Depending on the specific situation, hazards
can have different origins/natures. Examples of hazards are electricity, moving parts,
infectious bacteria, chemicals, gases, sharp edges, high currents, temperature, and
ionizing radiation.
6 Risk evaluation
GB/T 42062-2022 describes the process for risk evaluation. The standard, however,
does not specify levels of acceptable risk. The criteria for risk acceptability are based
on the manufacturer’s policy for determining acceptable risk and are documented in the
risk management plan.
7 Risk control
Several options exist to reduce risks associated with a medical device. These can be
used alone or in combination. The manufacturer can explore different options to reduce
the risks to acceptable levels in a reasonably practicable way.
Deviations or errors in manufacturing processes can compromise the safety of medical
devices, for example, by.
8 Evaluation of overall residual risk
The evaluation of overall residual risk is a challenging task that cannot be achieved by
adding all individual risks numerically. The difficulty arises for the following reasons.
9 Risk management review
The review of the execution of the risk management plan is not to be confused with the
review of the suitability of the risk management process at planned intervals by top
management (see 4.2.3).
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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