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YY/T 1437-2023: Medical devices - Guidance on the application of GB/T 42062
YY/T 1437-2023
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);
Medical devices - Guidance on the application of GB/T
42062-2022
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.
The risk management process can be part of a quality management system (for example
one that is based on GB/T 42061-2022 [15]) but this is not required by GB/T 42062-2022.
Some requirements in GB/T 42062-2022 (Clause 7 on product realization and 8.2.1 on
feedback during monitoring and measurement) are related to risk management and can
be fulfilled by applying GB/T 42062-2022.See also YY/T 0595-2020 [17].
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
4.1 Risk management process
GB/T 42062-2022 requires that the manufacturer establishes, implements, documents
and maintains an ongoing risk management process throughout the life cycle of the
medical device. The required elements in this process and the responsibilities of top
management are given in GB/T 42062-2022 and explained in further detail in this
document.
management plan for the particular medical device under development. Some inputs
for and considerations on the evaluation of overall residual risk are listed in Clause 8.
4.4.7 Verification activities
The risk management plan specifies how the two verification activities required per 7.2
of GB/T 42062-2022 are carried out. The risk management plan can detail the
verification activities explicitly or by reference to other plans.
Verification of implementation of risk control measures can be part of design review,
approval of specifications, design and development verification in a quality
management system, or other verification activities in a quality management system.
Verification of the effectiveness of risk control measures can be part of design and
development verification in a quality management system. It can require the collection
of clinical data, usability studies, etc., as part of design and development validation in
a quality management system.
4.4.8 Activities related to collection and review of production and post-production
information
GB/T 42062-2022 requires the manufacturer to establish a system to actively collect
and review information about the medical device in the production and post-production
phases and to review this information for relevance to safety. Thus, it is important that
th...