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YY/T 1837-2022: Medical electrical equipment - General requirements for reliability
YY/T 1837-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.010
CCS C 30
Medical electrical equipment - General requirements for
reliability
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Items Administration
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 General ... 9
4.1 Goals of reliability work ... 9
4.2 Basic principles of reliability work ... 9
4.3 Coordination of reliability work and other related work ... 10
4.4 Classification of reliability work ... 10
4.5 Description of reliability work requirements ... 10
4.6 Compliance guidelines ... 12
5 Reliability requirements analysis and requirements determination ... 12
5.1 User needs analysis ... 13
5.2 Environmental profile analysis... 13
5.3 Determination of reliability indicators ... 14
6 Reliability design and analysis ... 15
6.1 Establishment of reliability models ... 15
6.2 Reliability assignment ... 15
6.3 Reliability prediction ... 16
6.4 Design failure modes and effects analysis (DFMEA) ... 16
6.5 Failure tree analysis (FTA) ... 17
6.6 Development of reliability design criteria ... 18
6.7 Identification of reliability key parts ... 19
6.8 Selection and control of materials, components and parts ... 19
6.9 Finite element analysis ... 20
6.10 Derating analysis ... 20
6.11 Circuit tolerance analysis ... 21
6.12 Durability analysis ... 21
6.13 Reliability review ... 21
7 Reliability test and evaluation ... 22
7.1 Reliability R and D test ... 22
7.2 Reliability verification and evaluation ... 23
8 Manufacturing process reliability ... 25
8.1 Process failure mode and effects analysis (PFMEA) ... 25
8.2 Verification of manufacturing process reliability ... 25
8.3 Environmental stress screening ... 26
9 Collection and evaluation of use reliability information ... 26
Annex A (informative) Description of principle ... 27
Annex B (informative) Reliability requirements analysis ... 47
Annex C (informative) Environmental profile analysis ... 48
Annex D (informative) Reliability modeling ... 49
Annex E (informative) DFMEA form template ... 55
Annex F (informative) Failure tree FTA examples ... 57
Annex G (informative) Reliability evaluation of components and parts selection ... 60
Annex H (informative) Finite element analysis ... 61
Annex I (informative) Derating analysis method ... 62
Annex J (informative) Method and program of circuit tolerance analysis ... 66
Annex K (informative) Reference template for design review form ... 72
Annex L (informative) Growth test with known growth model ... 73
Annex M (informative) Reliability index verification - Examples of conventional test
and accelerated test methods ... 80
Annex N (informative) Examples of item failures introduced by the manufacturing
process ... 84
Annex O (informative) Environmental stress screening ... 85
Bibliography ... 88
Medical electrical equipment - General requirements for
reliability
1 Scope
This document specifies the general requirements and basic methods for carrying out
reliability work during the life cycle of medical electrical equipment (hereinafter
referred to as ME equipment) and medical electrical systems (hereinafter referred to as
ME system).
This document is applicable to the reliability work of various types of ME equipment
or ME system. This document does not contain relevant requirements and methods
specific to software reliability.
NOTE: All chapters and clauses in the main text of this document have corresponding relevant
principle explanations in Annex A.
2 Normative references
The following referenced documents are indispensable for the application 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 2900.1-2008, Electrotechnical terminology - Fundamental terms
GB 9706.1-2020, Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
YY/T 0316-2016, Medical devices - Application of risk management to medical
devices
YY/T 1813, Methods for operational reliability information collection and
evaluation of medical electrical equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/T 2900.1-
2008, GB 9706.1-2020, YY/T 0316-2016 as well as the followings apply.
3.1 safety
An analysis technology that analyzes the potential failure modes in the process of
manufacturing, assembly and logistics and their impact on items and upper-level items
and classifies and analyzes them according to the severity of the impact of the failure
modes, so as to ensure that the produced items meet the design.
[Source: GB/T 2900.99-2016, 192-11-05, modified]
3.9 environment profile
A sequential description of the various main environmental parameters that the ME
equipment or ME system will encounter during storage, transport, use.
3.10 accelerated test
To shorten the test time or find item defects, under the condition of not changing the
failure mode and failure mechanism, the test that is carried out by means of stress
increase or time compression or event compression.
[Source: GB/T 2900.99-2016, 192-09-08, modified]
3.11 reliability
The ability of ME equipment or ME system to perform a specified function under
specified conditions and within a specified time.
NOTE: The ability to perform specified functions includes at least the ability of ME equipment or
ME system to meet safety and effectiveness requirements.
[Source: GB/T 2900.99-2016, 192-01-24, modified]
3.12 reliability key parts
Parts that will seriously affect the safety and effectiveness of ME equipment or ME
system in the event of failure, or are highly complex, or have high technological content,
or are expensive, or have a high failure rate.
3.13 reliability work
A series of technical work to determine and meet the reliability requirements of ME
equipment or ME system.
3.14 reliability diagram
A logical, graphical representation of the system, revealing how the reliability of the
system's sub-items (represented by boxes) and their combinations affect system
reliability.
[Source: GB/T 2900.99-2016, 192-11-03]
3.15 reliability model
Establish the reliability block diagram and mathematical expression of the failure logic
relationship between the system and the unit. The model that is established for the
distribution, prediction, analysis or estimation of the reliability of the item.
[Source: GB/T 2900.99-2016, 192-11-02, modified]
3.16 operational reliability
The demonstrated reliability of ME equipment or ME system under actual conditions
of use. It reflects the comprehensive influence of item design, manufacturing,
installation, use, maintenance, environment and other factors.
NOTE: It mainly refers to the reliability of ME equipment or ME system after delivery.
3.17 design failure modes and effects analysis; DFMEA
An analytical technique that, in the design phase, ANALYZES each possible failure
mode of the item and its impact on the item and the upper item, and CLASSIFIES and
ANALYZES the solution according to the severity of the impact of the failure mode, so
as to ensure that potential failure modes and their associated causes or mechanisms of
fa...