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Delivery: <= 6 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.271-2022: Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy(NIRS) equipment Status: Valid
Basic dataStandard ID: GB 9706.271-2022 (GB9706.271-2022)Description (Translated English): Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy(NIRS) equipment Sector / Industry: National Standard Classification of Chinese Standard: C40 Classification of International Standard: 11.040.55 Word Count Estimation: 30,326 Date of Issue: 2022-12-29 Date of Implementation: 2026-01-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.271-2022: Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy(NIRS) equipment---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. ICS 11.040.55 CCSC40 National Standards of People's Republic of China Medical Electrical Equipment Part 2-71.Functionality Basic safety and Basic performance-specific requirements equipment (IEC 80601-2-71.2015, MOD) Released on 2022-12-29 2026-01-01 Implementation State Administration for Market Regulation Released by the National Standardization Management Committee table of contentsPreface I Introduction III 201.1 Scope, purpose and related criteria1 201.2 Normative references 2 201.3 Terms and Definitions 2 201.4 General requirements 4 201.5 General requirements for testing of ME EQUIPMENT 5 201.6 Classification of me equipment and me systems5 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 5 201.8 Protection against electric shock hazards for ME EQUIPMENT 5 201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 5 201.10 Protection against unwanted or excessive radiation hazards (sources)5 201.11 Protection against extreme temperatures and other hazards (sources)6 201.12 Accuracy of controls and instruments and protection against hazardous outputs6 201.13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 12 201.14 Programmable electrical medical systems (PEMS) 12 201.15 Construction of ME EQUIPMENT 12 201.16 ME system 12 201.17 Electromagnetic compatibility of me equipment and me systems12 Appendix 13 Appendix C (informative) Guiding requirements for marking and marking of me equipment and me systems 14 Appendix AA (Informative) General Guidelines and Rationale 15 Annex BB (normative) Evaluation of ME EQUIPMENT performance using a functional near-infrared spectroscopy phantom 17 Appendix CC (Informative) References to Basic Principles 23forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents" drafting. This document is part 2-71 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts. --- Part 1.General requirements for basic safety and essential performance; --- Part 1-3.General requirements for basic safety and essential performance Collateral standard. Radiation protection of diagnostic X-ray equipment; --- Part 2-1.Particular requirements for the basic safety and essential performance of electron accelerators with energies ranging from 1 MeV to 50 MeV; --- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories; --- Part 2-3.Special requirements for basic safety and basic performance of short-wave therapy equipment; --- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators; --- Part 2-5.Particular requirements for basic safety and basic performance of ultrasonic physiotherapy equipment; --- Part 2-6.Particular requirements for basic safety and basic performance of microwave therapy equipment; --- Part 2-8.Particular requirements for basic safety and essential performance of therapeutic X-ray equipment with energy from 10kV to 1MV; --- Part 2-11.Particular requirements for basic safety and essential performance of gamma beam therapy equipment; --- Part 2-12.Particular requirements for basic safety and basic performance of critical care ventilators; --- Part 2-13.Special requirements for basic safety and basic performance of anesthesia workstations; --- Part 2-16.Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment; --- Part 2-17.Particular requirements for basic safety and basic performance of automatically controlled brachytherapy afterloading equipment; --- Part 2-18.Particular requirements for basic safety and essential performance of endoscopic equipment; --- Part 2-19.Particular requirements for basic safety and basic performance of infant incubators; --- Part 2-22.Special requirements for basic safety and essential performance of laser equipment for surgery, plastic surgery, therapy and diagnosis; --- Part 2-24.Particular requirements for basic safety and essential performance of infusion pumps and infusion controllers; --- Part 2-25.Specific requirements for basic safety and basic performance of electrocardiographs; --- Part 2-26.Special requirements for basic safety and basic performance of EEG machines; --- Part 2-27.Special requirements for basic safety and basic performance of ECG monitoring equipment; --- Part 2-28.Particular requirements for basic safety and essential performance of medical diagnostic X-ray tube assemblies; --- Part 2-29.Particular requirements for basic safety and basic performance of radiotherapy simulators; --- Part 2-36.Particular requirements for the basic safety and essential performance of in vitro induced lithotripsy equipment; --- Part 2-37.Particular requirements for basic safety and essential performance of ultrasonic diagnostic and monitoring equipment; --- Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment; --- Part 2-43.Particular requirements for basic safety and essential performance of X-ray equipment for interventional operation; --- Part 2-44.Particular requirements for basic safety and essential performance of X-ray computed tomography equipment; --- Part 2-45.Particular requirements for basic safety and basic performance of mammography equipment and mammography stereotaxic devices; --- Part 2-54.Special requirements for basic safety and basic performance of X-ray photography and fluoroscopy equipment; --- Part 2-55.Particular requirements for basic safety and basic performance of respiratory gas monitors; --- Part 2-60.Particular requirements for basic safety and essential performance of dental equipment; --- Part 2-63.Particular requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging; --- Part 2-65.Particular requirements for basic safety and basic performance of dental X-ray machines for intraoral imaging; --- Part 2-71.Particular requirements for basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment; --- Part 2-75.Particular requirements for basic safety and essential performance of photodynamic therapy and photodynamic diagnostic equipment; --- Part 2-83.Particular requirements for the basic safety and essential performance of household phototherapy equipment; --- Part 2-90.Particular requirements for basic safety and essential performance of high-flow respiratory therapy equipment. This document is modified to adopt IEC 80601-2-71.2015 "Medical Electrical Equipment Part 2-71.Functional Near Infrared Spectroscopy (NIRS) Particular Requirements for Basic Safety and Essential Performance of Equipment”. The technical differences between this document and IEC 80601-2-71.2015 and their reasons are as follows. --- Replaced IEC 60825-1.2014 with the normative reference GB 7247.1-2012 (see.201.2,.201.3,.201.7.2.101, --- Replaced IEC 60601-1-6 (see.201.2,.201.3) with the normative referenced YY/T 9706.106 to adapt to my country's national conditions; --- Replaced IEC 60601-1 (see.201.2,.201.3) with the normatively quoted GB 9706.1 to adapt to my country's national conditions; --- Replaced ISO 80601-2-61 (see.201.1.1,.201.2) with normatively quoted YY0784 to adapt to my country's national conditions; --- Increased the normative reference document YY9706.257-2021 (see.201.2) to adapt to the national conditions of our country; ---Added the classification information specified in.201.6 of YY9706.257-2021 (see.201.7.2.101, Table.201.C.101) to apply Functional near-infrared spectroscopy equipment for incoherent light sources; --- It is clear that the filter for data processing in signal stability is a low-pass filter (see.201.12.1.101.6) to avoid ambiguity; ---Changed the calculation formula of the standard deviation δS in the signal-to-noise ratio (see.201.12.1.101.8), the international standard formula was edited incorrectly, and it was modified make corrections; --- Increased the test method of average optical power in the pulse output mode (see.201.12.1.101.2), so as to be applicable to all In the case of pulse modulation; --- Increase the shutter switching time requirements (see.201.12.1.107) to ensure the test accuracy of the response time. The following editorial changes have been made to this document. --- Deleted "References"; --- Deleted the "index of term definitions". Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the State Drug Administration.IntroductionSafety standards for medical electrical equipment, also known as the 9706 series of standards, consist of general standards, collateral standards, specific standards, guidelines and interpretations. ---General standard. The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. --- Parallel standards. safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards. ---Special standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard. ---Guidelines and interpretations. explanations for the application guidelines and clauses of the relevant requirements in the standards involved. In the GB 9706 series of standards, in addition to the published standards and this document, the planned standards are as follows. --- Part 2-66.Particular requirements for basic safety and essential performance of hearing devices and hearing device systems. The purpose is to build listening Particular requirements for basic safety and essential performance of equipment and hearing device systems. This document deals with the basic safety and essential performance requirements for functional near-infrared spectroscopy (NIRS) devices. This document has been amended and supplemented by GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance". Items marked with an asterisk (*) in this document have specific guidelines and rationale related to the project in Appendix AA. Appendix AA Relevant content not only contributes to the correct application of this document, but also speeds up the revision of the standard due to changes in clinical practice or technical development in a timely manner. standard process. Appendix CC gives the correspondence between this document and the basic principles of YY/T 0467-2016. Medical Electrical Equipment Part 2-71.Functionality Basic safety and Basic performance-specific requirements 201.1 Scope, purpose and relevant standards Except as described below, Chapter 1 of the general standard applies. 201.1.1 Scope replace. This document applies to functional near-infrared spectroscopy for the intended purpose of aiding diagnosis by itself or as part of an ME system The basic safety and basic performance of the equipment (hereinafter referred to as ME equipment). The scope of this document does not include. a) as part of ME EQUIPMENT for the measurement of hemoglobin oxygen saturation in microvessels (capillaries, arterioles and venules) and degree; b) near-infrared spectroscopy (NIRS) tissue oximeters not intended to be used to obtain the output of a functional near-infrared spectroscopy device; c) Pulse oximeters that are not intended to be used to obtain the output of functional near-infrared spectroscopy equipment, see YY0784 for requirements; d) For frequency domain and time domain equipment for functional near-infrared spectroscopy, different inspection procedures than those specified in this document may be used; e) A functional near-infrared spectroscopic device for measuring changes in the concentration of chromophores other than oxygenated and deoxygenated hemoglobin, using different The inspection procedures specified in this document. 201.1.2 Purpose replace. The purpose of this document is to specify the basic safety and essential performance specific requirements for functional near-infrared devices. 201.1.3 Collateral Standards Supplement. This document refers to Chapter 2 of the General Standard and applicable collateral standards listed in.201.2 of this document. GB 9706.103 and YY/T 9706.110 are not applicable. All other published GB 9706.1 collateral standards apply. 201.1.4 Particular standards replace. In the GB 9706 series of standards, specific standards may modify, replace or delete the requirements contained in general standards or collateral standards to apply Other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements may also be added depending on the ME EQUIPMENT considered. The requirements of a particular standard take precedence over those of a general standard. In this document, GB 9706.1-2020 is referred to as the general standard. Collateral standards are indicated by their respective document numbers. The numbering of chapters and clauses in this document corresponds to the general standard by adding the prefix "201" (for example,.201.1 in this document corresponds to the general standard Chapter 1), or correspond to the applicable collateral standard by adding the prefix "20×", where × is the number of the international standard corresponding to the parallel standard The last digit (for example, 202.4 in this document corresponds to the content of Chapter 4 in the collateral standard YY9706.102-2021, and 203.4 in this document corresponds to ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.271-2022_English be delivered?Answer: Upon your order, we will start to translate GB 9706.271-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 4 ~ 6 working days. 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