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Delivery: <= 8 days. True-PDF full-copy in English will be manually translated and delivered via email. GB 9706.204-2022: Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators Status: Valid
Basic dataStandard ID: GB 9706.204-2022 (GB9706.204-2022)Description (Translated English): Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators Sector / Industry: National Standard Classification of Chinese Standard: C39 Word Count Estimation: 61,665 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB 9706.204-2022: Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators---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. Medical electrical equipment - Part 2-4.Particular requirements for the basic safety and essential performance of cardiac defibrillators ICS 11.040.10 CCSC39 National Standards of People's Republic of China Replacing GB 9706.8-2009 Medical Electrical Equipment Part 2-4.Cardiac Defibrillators Particular requirements for basic safety and basic performance (IEC 60601-2-4.2018,MOD) Published on 2022-07-13 2024-08-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface III Introduction V 201.1 Scope, Purpose and Related Criteria1 201.2 Normative References 2 201.3 Terms and Definitions 3 201.4 General Requirements 5 201.5 General Requirements for ME EQUIPMENT Testing 5 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 6 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 6 201.8 ME EQUIPMENT PROTECTION FROM ELECTRIC SHOCK HAZARD9 201.9 Protection of me equipment and me systems against mechanical hazards 14 201.10 Protection against unwanted or excessive radiation hazards (sources) 14 201.11 Protection against ultra-temperature and other hazards (sources) 14 201.12 * Accuracy of controllers and instruments and protection of hazardous outputs 15 201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAILURE STATES 17 201.14 Programmable Medical Electrical System (PEMS) 17 201.15 Structure of ME equipment 17 201.16 ME System 20 201.17 Electromagnetic compatibility of me equipment and me systems 20 201.101 *Charging time 21 201.102 Internal power supply 22 201.103 * Persistence 24 201.104 * Synchronizer 24 201.105 * Recovery of monitor and/or ECG input after defibrillation 24 201.106 * Interference with monitors by charging or internal discharge 27 201.107 * Requirements for heart rhythm recognition detectors 28 201.108 Defibrillator electrodes 29 201.109 *External Pacing 30 202 * Electromagnetic compatibility requirements and tests 34 Addendum 37 Appendix C (Informative) Guidance Requirements for Marking and Identification of ME EQUIPMENT and ME SYSTEMS 38 Appendix AA (Informative) Specific Guidelines and Rationale 40 Appendix BB (informative) GB 9706.8-2009 and the content mapping of this document50 Reference 54 Figure.201.101 Dynamic test of energy limits for different parts of ME EQUIPMENT 10 Figure.201.102 Permissible current and applied test voltage (see this clause) 13 Figure.201.103 Examples of wire fixtures to be tested [see.201.15.4.101b)] 19 Figure.201.104 Test device for flexible cords and their fixtures [see.201.15.4.101b), test 2] 20 Figure.201.105 Recovery test device after defibrillation (see this article) 26 Figure.201.106 Placement of monitoring electrodes on sponge (see this article) 26 Figure.201.107 Recovery test device after defibrillation (see this item) 27 Figure.201.108 Test set-up for disturbances caused by charging and internal discharge (see this subclause) 28 Figure.201.110 Test circuit 34 for overload test of defibrillator pacing output circuit Figure AA.1 Simulated patient load 49 Table.201.101 Basic performance requirements for dispersion 5 Table.201.102 Classification of Heart Rate Recognition Detectors 28 Table.201.C.101 Cardiac Defibrillator or its Parts External Marking 38 Table.201.C.102 Defibrillator Controller and Instrument Marking 38 Form.201.C.103 Accompanying Documents and Overview 38 Table.201.C.104 Instructions for Use of Accompanying Documents 39 Table.201.C.105 Accompanying Documents Technical Notes 39 Table BB.1 GB 9706.8-2009 and the content mapping of this document50 forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document is part 2-4 of GB 9706 "Medical Electrical Equipment". GB 9706 has released the following parts. --- Part 1.General requirements for basic safety and basic performance; --- Part 1-3.General Requirements for Basic Safety and Essential Performance Collateral Standard. Radiation Protection of Diagnostic X-ray Equipment; --- Part 2-1.Specific requirements for basic safety and basic performance of electron accelerators with energies from 1MeV to 50MeV; --- Part 2-2.Special requirements for basic safety and basic performance of high-frequency surgical equipment and high-frequency accessories; --- Part 2-3.Specific requirements for basic safety and basic performance of shortwave therapy equipment; --- Part 2-4.Particular requirements for basic safety and basic performance of cardiac defibrillators; --- Part 2-5.Specific requirements for the basic safety and basic performance of ultrasonic physiotherapy equipment; --- Part 2-6.Specific requirements for basic safety and basic performance of microwave therapy equipment; --- Part 2-8.Particular requirements for basic safety and basic performance of therapeutic X-ray equipment with energy from 10kV to 1MV; --- Part 2-11.Particular requirements for basic safety and basic performance of gamma beam therapy equipment; --- Part 2-12.Specific requirements for basic safety and basic performance of critical care ventilators; --- Part 2-13.Particular requirements for basic safety and basic performance of anesthesia workstations; --- Part 2-16.Particular requirements for basic safety and basic performance of hemodialysis, hemodiafiltration and hemofiltration equipment; --- Part 2-17.Special requirements for the basic safety and basic performance of automatically controlled brachytherapy afterloading equipment; --- Part 2-18.Particular requirements for basic safety and basic performance of endoscopic equipment; --- Part 2-19.Specific requirements for the basic safety and basic performance of infant incubators; --- Part 2-24.Particular requirements for basic safety and basic performance of infusion pumps and infusion controllers; --- Part 2-25.Particular requirements for basic safety and basic performance of electrocardiographs; --- Part 2-26.Specific requirements for basic safety and basic performance of EEG machines; --- Part 2-27.Particular requirements for basic safety and basic performance of ECG monitoring equipment; --- Part 2-28.Particular requirements for basic safety and basic performance of medical diagnostic X-ray tube assemblies; --- Part 2-29.Specific requirements for basic safety and basic performance of radiotherapy simulators; --- Part 2-36.Particular requirements for the basic safety and basic performance of in vitro induced lithotripsy equipment; --- Part 2-37.Particular requirements for basic safety and basic 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 basic performance of interventional X-ray equipment; --- Part 2-44.Particular requirements for the basic safety and basic performance of X-ray computed tomography equipment; --- Part 2-45.Mammography equipment and mammography stereotaxic devices for basic safety and basic performance specific Require; --- Part 2-54.Particular requirements for the basic safety and basic performance of X-ray photography and fluoroscopy equipment; --- Part 2-60.Particular requirements for basic safety and basic performance of dental equipment; --- Part 2-63.Special requirements for basic safety and basic performance of dental X-ray machines for extraoral imaging; --- Part 2-65.Special requirements for basic safety and basic performance of intraoral imaging dental X-ray machines. This document replaces GB 9706.8-2009 "Medical Electrical Equipment Part 2-4.Special Requirements for the Safety of Cardiac Defibrillators", and Compared with GB 9706.8-2009, in addition to structural adjustment and editorial changes, the main technical changes are as follows. --- Added basic performance requirements (201.4.3); --- Added requirements for defibrillator electrodes (201.7.2.103); --- Added requirements for external pacing (201.109); --- Changed some test methods and test circuits. This document is modified to adopt IEC 60601-2-4.2018 "Medical Electrical Equipment Part 2-4.Basic Safety and Fundamentals of Cardiac Defibrillators Capability-Specific Requirements". The technical differences between this document and IEC 60601-2-4.2018 and their reasons are as follows. --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the adjustment situation Centrally reflected in.201.2 "Normative Reference Documents", the specific adjustments are as follows. ● Replace CISPR11 with GB 4824-2019 which is equivalent to adopting international standards; ● Replacing IEC 60601-1.2005/AMD1.2012 with GB 9706.1-2020 which is modified to adopt international standards; ● Replace IEC 61000-4-2 with GB/T 17626.2 which is equivalent to adopting international standards; ● Replace IEC 61000-4-3 with GB/T 17626.3 which is equivalent to adopting international standards; ● Replace IEC 61000-4-4 with GB/T 17626.4 which is equivalent to adopting international standards; ● Replace IEC 61000-4-5 with GB/T 17626.5-2019 which is equivalent to adopting international standards; ● Replace IEC 61000-4-8 with GB/T 17626.8 which is equivalent to adopting international standards; ● Replace ISO 15223-1.2016 with YY/T 0466.1-2016 which is equivalent to adopting international standards; ● Replacing IEC 60601-1-2.2014 with YY9706.102-2021 which has been modified to adopt the international standard. --- Delete the third paragraph in.201.102.3.1, because the content of the third paragraph and the fifth paragraph in the original text are repeated. --- Changed Figure.201.106, adding a metal plate between the electrode and the sponge. ---201.108.1.11 The conversion unit "pound" (4lb) has been deleted. The following editorial changes have been made to this document. ---The column item symbols in.201.106 are numbered sequentially, and the column items a), b) and c) appearing for the second time in the original text are changed to c), d) and e); in the corresponding penultimate paragraph "b) and c)" are changed to "c) and d)"; --- Removed the column item symbol "d)" in.201.107; ---.201.109.7 added a note stating "ppm"; --- In.201.108.105, ISO 10993 (all parts) for informative references was replaced with "standards related to biocompatibility"; --- Replaced IEC 60529 with GB/T 4208-2017 cited for information; ---Replace ANSI/AAMIEC 12.2000 with YY/T 0196-2005 and YY1079-2008 cited for information and ANSI/AAMIEC 13.2002; --- Removed the term index at the end of the text. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the State Drug Administration. The previous versions of this document and its superseded documents are as follows. ---First published in.1995 as GB 9706.8-1995, first revised in.2009. ---This is the second revision.IntroductionMedical electrical equipment safety standards, also known as the 9706 series of standards, consist of general standards, side-by-side standards, specific standards, guidelines and interpretations. ---General standard. Medical electrical equipment should be generally applicable to safety standards, that is, equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements. --- Side-by-side standard. Medical electrical equipment should be generally applicable to the safety standards, but in most cases only limited to some specific functions or special Only devices that are sexual are required to meet the requirements of such standards. ---Special standard. a safety standard applicable to a certain type of medical electrical equipment, and not all medical electrical equipment has special standard. --- Guidance and interpretation. application guidance and interpretation 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 2-22.Special requirements for the basic safety and basic performance of laser equipment for surgical, plastic, therapeutic and diagnostic use. the purpose is Establish specific requirements for the basic safety and basic performance of laser equipment for surgical, orthopedic, therapeutic and diagnostic use. --- Part 2-66.Specific requirements for the basic safety and basic performance of hearing devices and hearing device systems. The purpose is to build hearing Particular requirements for basic safety and basic performance of equipment and hearing device systems. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance" , hereinafter referred to as the general standard. In this document, an asterisk (*) is used as the first character of a title or the beginning of a paragraph or table title, indicating that there is a reference to this item in Appendix AA. Specific guidelines and principles related to the project are provided. See Appendix BB for the mapping relationship between this document and the contents of GB 9706.8-2009. Medical Electrical Equipment Part 2-4.Cardiac Defibrillators Particular requirements for basic safety and basic performance 201.1 Scope, Purpose and Related Standards Except as described below, Chapter 1 of the General Standard applies. 201.1.1 *Scope replace. This document specifies the basic safety and essential performance of cardiac defibrillators. This document applies to the use of external electrodes applied to the patient's A defibrillator (hereafter referred to as ME) used to normalize the heart rhythm by applying electrical impulses to the exposed heart through the skin, or using internal electrodes equipment). If a chapter or article is clearly stated to apply only to ME EQUIPMENT or ME SYSTEMS, the title and the body of the chapter or article will state that. if not In this case, the relevant chapter or clause applies to both ME EQUIPMENT and ME SYSTEM. In addition to 7.2.13 and 8.4.1 of the General Standard, results from expected physiological effects of ME EQUIPMENT or ME SYSTEMS within the scope of this document Hazards are not specifically required in this document. Note. See 4.2 of the general standard. This document does not apply to implantable defibrillators, remote defibrillators, and stand-alone heart monitors (in compliance with GB 9706.227-2021). use Cardiac monitors with independent ECG monitoring electrodes are not within the scope of this document unless they are used as an AED for rhythm recognition detection or synchronization of cardiac The only criteria used for cardiac beat detection for electrical cardioversion. The defibrillator electrodes described in.201.108 can also be used for electrocardiogram (ECG) monitoring; Because the electrode area is too large, the requirements of GB 9706.227-2021 do not apply to defibrillator electrodes. Defibrillation waveform technology has developed rapidly. Literature studies have shown that the effectiveness of different waveforms is different. The scope of application of this document is expressly The selection of special waveforms is not included, it includes waveform shape, energy release, efficacy and safety. However, since the importance of the treatment waveform is critical, a note has been added to the rationale explaining how the waveform's choose. 201.1.2 Purpose replace. The purpose of this document is to establish the specific requirements for essential safety and essential performance of cardiac defibrillators as defined in.201.3.202. 201.1.3 Tied standards Added. This document refers to Chapter 2 of the General Standard and the applicable collateral standards listed in.201.2 of this document. YY9706.102-2021 applies after modification in Chapter 202.All published parallel standards in the GB 9706 series of standards are in accordance with The current release version applies. 201.1.4 Particular standards replace. In the GB 9706 series, the special standard may modify, replace or delete the general standard or the parallel standard according to the special ME EQUIPMENT under consideration. The requirements contained in the standard may supplement other essential safety and essential performance requirements. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB 9706.204-2022_English be delivered?Answer: Upon your order, we will start to translate GB 9706.204-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 5 ~ 8 working days. 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