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YY/T 1813-2022: Methods for operational reliability information collection and evaluation of medical electrical equipment
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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 CCS C 30 Method for Operational Reliability Information Collection and Evaluation of Medical Electrical Equipment Issued on. MAY 18, 2022 Implemented on. JUNE 01, 2023 Issued by. National Medical Products Administration
Table of Contents
Foreword... 3 1 Scope... 4 2 Normative References... 4 3 Terms and Definitions... 4 4 Collection of Operational Reliability Information of ME Equipment and ME Systems ... 8 4.1 Sources of operational reliability information... 8 4.2 Contents of operational reliability information... 9 4.3 Fault judgment and record... 12 5 Assessment of Operational Reliability of ME Equipment and ME Systems... 14 5.1 Overview... 14 5.2 Determining the assessment indicators of operational reliability... 14 5.3 Determination of samples... 14 5.4 Preliminary collation of operational reliability information... 15 5.5 Inspection method of distribution type... 16 5.6 Parameter estimation for continuous distributions... 16 5.7 Preparation of assessment report of operational reliability... 16 Appendix A (Informative) Collection Form of Operational Reliability Information of ME Equipment and ME Systems... 17 Appendix B (Informative) Description of Other Relevant Operational Reliability Parameters for ME Equipment and ME Systems... 19 Appendix C (Informative) Introduction to Relevant Distribution Models... 24 Appendix D (informative) Inspection of Relevant Distribution Type... 27 Bibliography... 29Foreword
This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization – Part 1.Rules for the Structure and Drafting of Standardizing Documents. Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Document was proposed by National Medical Products Administration. This Document shall be under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10). Drafting organizations of this Document. Chinese PLA General Hospital; Shanghai Testing & Inspection Institute for Medical Devices; Center for Medical Device Evaluation, NMPA; Shanghai United Imaging Healthcare Co., Ltd.; Hangwei GE Medical Systems Co., Ltd.; Siemens Shanghai Medical Equipment Ltd.; Shanghai MicroPort Medical (Group) Co., Ltd.; Fresenius Medical Care R&D (Shanghai) Co., Ltd.; Philips (China) Investment Co., Ltd.; and Shanghai 6th People’s Hospital. Chief drafting staffs of this Document. He Kunlun, Yu Hongyi, Zhou Juan, Zhang Weiqiang, He Fei, Cao Desen, Zheng Chen, Li Bin, Gao Jian, Li Qi, Liu Mingqiang, Wu Xiumei, Chen Jie, and Tao Kan. Method for Operational Reliability Information Collection and Evaluation of Medical Electrical Equipment1 Scope
This Document specifies the methods for collecting operational reliability information and assessing the operational reliability of medical electrical equipment and medical electrical systems (hereinafter referred to as ME equipment and ME systems) within the period of use specified by the manufacturer. This Document is applicable to the collection of operational reliability information and assessment of operational reliability assessment of ME equipment and ME systems.2 Normative References
The provisions in following documents become the essential provisions of this Document through reference in this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document. GB 9706.1-2020 Medical Electrical Equipment - Part 1.General Requirements for Basic Safety and Essential Performance YY/T 1837-2022 Medical Electrical Equipment - General Requirements for Reliability3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB 9706.1-2020 and YY/T 1837-2022 and the following apply. 3.1 Parameter estimation Infer unknown total distribution parameters from a sample. The process of estimating parameters or parameter functions used to characterize reliability indicators in the analysis of operational reliability data of ME equipment and ME systems. [SOURCE. GB/T 17560-1998, 3.1.1, modified] 3.2 Distribution model A specific distribution or class of distributions. [SOURCE. GB/T 3358.2-2009, 2.5.3, modified] 3.3 Distribution function A function of a random variable having a value less than or equal to the probability of any chosen value. 3.4 Fault Loss of ability to perform as required due to intrinsic condition.4 Collection of Operational Reliability Information of ME
Equipment and ME Systems 4.1 Sources of operational reliability information It mainly comes from the relevant records of reliability information during the use process of ME equipment and ME system after delivery, such as operation records, repair records, maintenance records, etc. 4.2 Contents of operational reliability information 4.2.3 Environmental condition information Environmental conditions for ME equipment and ME systems include temperature, humidity, atmospheric pressure, etc. The following factors also need to be recorded if they affect the reliability of ME equipment and ME system. 4.2.4 Operation condition The information that can be collected from the operation condition of ME equipment and ME systems. 4.2.5 Fault information Fault information than can be collected by ME equipment and ME systems. 4.2.7 Repair and maintenance information The repair and maintenance information that may be collected by ME equipment and ME systems include. 4.3 Fault judgment and record 4.3.1 Fault classification The fault classification method of ME equipment and ME systems are as follows. 4.3.2 Statistics principles of fault According to the following principles, faults are classified, counted and judged.5 Assessment of Operational Reliability of ME Equipment
and ME Systems 5.1 Overview 5.1.1 Assess the reliability level achieved by ME equipment and ME systems under actual use conditions; and verify whether the ME equipment and ME systems meet the specified operational reliability requirements. 5.2 Determining the assessment indicators of operational reliability 5.2.1 When the ME equipment and the ME systems are maintainable, the mean time between failures (MTBF) can be selected as the indicator used for reliability analysis and evaluation, generally denoted as θ. 5.3 Determination of samples Determine the product model, batch number, component model and batch number, serial number range, etc. of the ME equipment and ME systems to be analyzed, determine a specific fault mode, and determine the use time for analysis and evaluation samples (such as the expected useful life of the whole machine) as a screening factor for analyzing samples. 5.4 Preliminary collation of operational reliability information 5.4.2 Analysis of sample empirical distribution The analysis of sample empirical distribution should be carried out through the histogram. 5.5 Inspection method of distribution type 5.5.1 Inspection by graph estimation method According to the type of sample distribution, the inspection by graph estimation method can refer to the following methods. 5.6 Parameter estimation for continuous distributions 5.6.3 Refer to GB/T 34987-2017 for parameter estimation of Weibull distribution. 5.7 Preparation of assessment report of operational reliability The content of the text of the operational reliability assessment report shall include elements such as ME equipment and ME systems information, data range, assessment method, assessment process, and assessment results, etc. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
