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YY/T 1837-2022: Medical electrical equipment - General requirements for reliability Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY/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/YYT1837-2022YY 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 ContentsForeword... 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... 881 ScopeThis 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 referencesThe 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 equipment3 Terms and definitionsFor 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 General4.1 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 determination5.1 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 analysis6.1 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 evaluation7.1 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 reliability8.1 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 informationThrough 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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