YY/T 1837-2022 PDF English
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YY/T 1837-2022: Medical electrical equipment - General requirements for reliability---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/YYT1837-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
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&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
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
It will not pose an unacceptable risk to persons, property or the environment.
3.2 part
The main constituent unit module of the equipment. It is composed of more than one
component.
3.3 item
Object of consideration.
3.4 risk
The combination of the probability of an injury occurring and the severity of that injury.
3.5 risk analysis
The process of systematically using available information to identify hazards (sources)
and estimate risks.
3.6 risk management
The systematic application of management policies, procedures and practices for risk
analysis, evaluation, control and monitoring.
4 General
4.1 Goals of reliability work
The goal of carrying out reliability work is to ensure that ME equipment or ME system
meets the specified reliability requirements, and to maintain and improve the reliability
level of ME equipment or ME system.
4.2 Basic principles of reliability work
The basic principles of reliability work mainly include.
4.3 Coordination of reliability work and other related work
Reliability work needs to be coordinated with other related work, mainly including.
4.4 Classification of reliability work
Reliability work is divided into basic work and optional work. The principles for
selecting various types of work for ME equipment or ME system are shown in Table 1.
4.5 Description of reliability work requirements
The ME equipment or ME system manufacturer shall develop a reliability plan for the
ME equipment or ME system during the project establishment and demonstration phase
of the ME equipment or ME system. Make comprehensive arrangements for the
reliability work during the life cycle of ME equipment or ME system. Define the work
to be done at each phase. Clarify work requirements. The reliability work list for each
phase is shown in Table 2.
5 Reliability requirements analysis and requirements determination
5.1 User needs analysis
User needs analysis shall be carried out as early as possible in the early phase of ME
equipment or ME system R&D project approval. Provide information for the
determination of reliability requirements to meet the actual use needs of ME equipment
or ME system.
5.2 Environmental profile analysis
Various environmental factors that may affect the equipment during the equipment life
cycle shall be determined according to the characteristics of the ME equipment or ME
system. Determine the main environmental parameters by analyzing the collected
information. At the same time, the comprehensive effect of various environmental
factors is considered, so as to obtain the environmental profile of the ME equipment or
ME system. Environmental profile analysis can be used as input for ME equipment or
ME system development and design. It can provide reference for reliability test.
5.3 Determination of reliability indicators
Reliability quantitative indicators suitable for ME equipment or ME system
characteristics shall be determined, such as mean time between failures (MTBF), mean
time to failure (MTTF), failure rate, reliability. The work of determining the reliability
indicators of ME equipment or ME system shall pay attention to the following.
6 Reliability design and analysis
6.1 Establishment of reliability models
To carry out reliability allocation, prediction and evaluation, the reliability model of the
whole machine equipment or subsystem shall be established. The reliability model
includes the reliability diagram and the corresponding mathematical model.
Reliability modeling procedures, processes and precautions are as follows.
6.2 Reliability assignment
The reliability indicator of the item shall be decomposed step by step into the reliability
indicator of subsystems, components and devices. This is a process of decomposition
from whole to part, from top to bottom. After the allocation of reliability indicators is
completed, the responsibility for the indicators shall be assigned to the relevant design
department. The general workflow and precautions for reliability assignment are as
follows.
6.3 Reliability prediction
The reliability indicator of ME equipment or ME system shall be estimated. Whether
the proposed design scheme can meet the specified reliability quantitative requirements
shall be evaluated. The general procedures, methods and precautions for reliability
prediction work are as follows.
6.4 Design failure modes and effects analysis (DFMEA)
Failure mode and effects analysis (FMEA) is a systematic procedure for the systematic
analysis of ME equipment or ME system to identify potential failure modes, failure
mechanisms, failure causes and their effects on ME equipment or ME system, parts,
components. Determine all possible failure modes of ME equipment or ME system,
parts or components by systematic analysis, as well as the mechanism, cause, inspection
method and effect of each failure mode. Identify potential weaknesses. Propose
improvement measures. Design failure modes and effects analysis (DFMEA) refers to
the FMEA performed during the design phase. Manufacturers can perform analysis of
specific objects based on the characteristics of the ME equipment or ME system.
6.5 Failure tree analysis (FTA)
Failure tree analysis can be carried out as required. Failure tree analysis is one of the
tools for system reliability analysis. Failure tree analysis can provide a complex
diagram to help the user visualize possible preventive/corrective actions.
When carrying out the failure tree analysis of the item, it is advisable to refer to the
following.
6.6 Development of reliability design criteria
6.8 Selection and control of materials, components and parts
Clearly control the selection and use of materials, components and parts for ME
equipment or ME system. Ensure that the materials, components and parts used in ME
equipment or ME system have a good and stable quality level and a good reliability
level.
6.9 Finite element analysis
Analyze and evaluate the mechanical strength and thermal response characteristics of
ME equipment or ME system during the design process. Carry out early detection of
weak links in load-bearing structures and materials and thermally sensitive points of
ME equipment or ME system. Take timely design improvement measures. The
following shall be paid attention to in the process of finite element analysis.
6.10 Derating analysis
Reduce the working stress (electrical, thermal, mechanical, etc.) applied to components,
so that the stress of the components in use is lower than their rated stress. Achieve the
purpose of delaying the degradation of its parameters, thereby reducing the failure rate
of components and improving the reliability of use. The following shall be paid
attention to when derating analysis.
6.11 Circuit tolerance analysis
Analyze the influence of the parameter deviation and parasitic parameters of the
composition of the circuit on the circuit performance tolerance within the specified
range of environmental conditions. According to the analysis results, corresponding
improvement measures are put forward. The following shall be paid attention to when
analyzing circuit tolerance.
6.12 Durability analysis
Identify the parts that may fail prematurely due to wear. Determine the root cause of
the failure and possible corrective actions. The following shall be paid attention to in
the durability analysis.
6.13 Reliability review
During the design process of ME equipment or ME system, review the reliability work
carried out as planned, such as reliability requirements, reliability modeling. Check and
supervise the quality of reliability design work, so as to achieve the specified reliability
work requirements. The following shall be paid attention to when evaluating reliability.
7 Reliability test and evaluation
7.1 Reliability R&D test
Find potential defects in ME equipment or ME system by applying appropriate working
loads and environmental stresses to ME equipment or ME system, so as to improve the
design to increase the inherent reliability level of ME equipment or ME system.
Mathematical models are used to characterize the level of item reliability growth, so as
to meet the requirements of reliability indicators in a more planned way.
Reliability R&D test content and points for attention are as follows.
7.2 Reliability verification and evaluation
Determine whether the ME equipment or ME system meets the specified reliability
indicator requirements. Comprehensively evaluate the reliability of ME equipment or
ME system under typical working environment conditions. Record and analyze the
failures that occur.
8 Manufacturing process reliability
8.1 Process failure mode and effects analysis (PFMEA)
The purpose of PFMEA is to identify the potential failure mode of the manufacturing
process, analyze and determine its impact on the manufacturing process, ME equipment
or ME system, and propose manufacturing process control measures, so as to eliminate
or control the weak link of the manufacturing process and improve the ME equipment
or ME system reliability.
8.2 Verification of manufacturing process reliability
Through the reliability test evaluation method, verify the part processing technology
and the whole machine assembly process that may affect the reliability of ME
equipment or ME system, so as to meet the process reliability guarantee capability of
ME equipment or ME system.
8.3 Environmental stress screening
Establish and implement screening procedures for ME equipment or ME system, so as
to detect and eliminate early failures due to defects introduced by defective components,
parts, manufacturing processes and other causes.
The stages, objects and methods of environmental stress screening can refer to the
following.
9 Collection and evaluation of use reliability information
Through the planned collection of reliability information on ME equipment or ME
system for the period of use specified by the manufacturer, evaluate whether the
reliability level achieved under actual use conditions meets the specified use reliability
requirements. The specific requirements and methods shall be carried out in accordance
with YY/T 1813.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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