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GB 9706.1-2020: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid GB 9706.1: Historical versions
Similar standardsGB 9706.1-2020: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance---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/GB9706.1-2020 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 30 Replacing GB 9706.1-2007, GB 9706.15-2008 Medical electrical equipment - Part 1.General requirements for basic safety and essential performance (IEC 60601-1.2012, MOD) Issued on: APRIL 09, 2020 Implemented on: MAY 01, 2023 Issued by. State Administration for Market Regulation; Standardization Administration of the PRC. Table of ContentsForeword... 4 1 Scope, object and related standards... 11 2 Normative references... 12 3 * Terminology and definitions... 17 4 General requirements... 51 5 * General requirements for testing ME EQUIPMENT... 62 6 * Classification of ME EQUIPMENT and ME SYSTEMS... 69 7 ME EQUIPMENT identification, marking and documents... 70 8 * Protection against electrical HAZARDS from ME EQUIPMENT... 96 9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS... 174 10 * Protection against unwanted and excessive radiation HAZARDS... 204 11 Protection against excessive temperatures and other HAZARDS... 207 12 * Accuracy of controls and instruments and protection against hazardous outputs... 226 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 229 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 238 15 Construction of ME EQUIPMENT... 246 16 * ME SYSTEMS... 265 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS.. 274 Annex A (Informative) General guidance and rationale... 275 Annex B (Informative) Sequence of testing... 435 Annex C (Informative) Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS... 439 Annex D (Informative) Symbols on marking... 443 Annex E (Informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT (see 8.7)... 452ForewordAll technical content of this Part is mandatory. GB 9706 "Medical electrical equipment" is divided into the following parts. - Part 1.General requirements for basic safety and essential performance; - Part 1-3.General requirements for safety - 3.Collateral standard. General requirements for radiation protection in diagnostic X-ray equipment - Part 2-1.Particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV; - Part 2-2.Particular requirements for the safety of high frequency surgical equipment; - Part 2-3.Particular requirements for the basic safety and essential performance of short-wave therapy equipment; - Part 2-4.Particular requirements for the safety of cardiac defibrillators; - Part 2-5.Particular requirements for the safety of ultrasonic physiotherapy equipment; - Part 2-6.Particular requirements for the basic safety and essential performance of microwave therapy equipment; - Part 2-8.Particular requirements for basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV; - Part 2-11.Particular requirements for the basic safety and essential performance of gamma beam therapy equipment; - Part 2-12.Particular requirements for basic safety and essential performance of critical care ventilators; - Part 2-13.Particular requirements for basic safety and essential performance of an anaesthetic workstation; - Part 2-16.Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment; - Part 2-17.Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy after-loading equipment; - Part 2-18.Particular requirements for the basic safety and essential performance of endoscopic equipment; - Part 2-19.Particular requirements for the basic safety and essential performance of infant incubators; - Part 2-22.Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; - Part 2-24.Particular requirements for the safety of infusion pumps and controllers; - Part 2-25.Particular requirements for the basic safety and essential performance of electrocardiographs; - Part 2-26.Particular requirements for the basic safety and essential performance of electroencephalograph; - Part 2-27.Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment; - Part 2-28.Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis; - Part 2-29.Particular requirements for the basic safety and essential performance of radiotherapy simulators; - Part 2-36.Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy; - Part 2-37.Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment; - Part 2-39.Particular requirements for the safety of peritoneal dialysis equipment; - Part 2-43.Particular requirements for the safety of X-ray equipment for interventional procedures; - Part 2-44.Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography; - Part 2-45.Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices; - Part 2-54.Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy; - Part 2-60.Particular requirements for the basic safety and essential performance of dental equipment; - Part 2-63.Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment; - Part 2-65.Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment; - Part 2-66.Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems. This Part is Part 1 of GB 9706. This Part is drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces GB 9706.1-2007 "Medical electrical equipment - Part 1. General requirements for safety" and GB 9706.15-2008 "Medical electrical equipment - Part 1.General requirements for safety - 1.Collateral standard. Safety requirements for medical electrical systems". This Part is based on GB 9706.1-2007 and integrates all the contents of GB 9706.15-2008.Compared with GB 9706.1-2007, in addition to editorial changes, the main technical changes are as follows. - Incorporate the contents of GB 9706.15 and YY/T 0708 into this Part; - ADD requirements for essential performance (see Clause 4); - ADD the concept of expected service life (see 4.4); - ADD content related to risk management (see 4.2); - ADD different requirements for operator protection and patient protection (see Clause 8); - Modify the test requirements for protection against electric shock (see Clause 8; Clause 3 of the 2007 edition); - ADD relevant requirements for mechanical safety (see Clause 9); - ADD fire prevention requirements (see 11.3). This Part uses the redraft law to modify and adopt IEC 60601-1.2012 "Medical electrical equipment - Part 1.General requirements for basic safety and essential performance". The technical differences between this Part and IEC 60601-1.2012 and their reasons are as follows. Medical electrical equipment - Part 1.General requirements for basic safety and essential performance1 Scope, object and related standards1.1 * Scope This Part of GB 9706 specifies the GENERAL REQUIREMENTS for BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This Part applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.2 Normative referencesThe following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document. GB/T 191 Packaging - Pictorial Marking for Handling of Goods (GB/T 191- 2008, ISO 780.1997, MOD) GB/T 1002 Single phase plugs and socket-outlets for household and similar purpose -Types, basic parameters and dimensions GB/T 1003 Three phases plugs and socket-outlets for household and similar purposes - Types, basic parameters and dimensions GB/T 2099.1 Plugs and socket-outlets for household and similar purposes - Part 1.General requirements (GB/T 2099.1-2008, IEC 60884-1.2006, MOD) GB/T 2423.2-2008 Environmental testing - Part 2.Test methods - Tests B. Dry heat (IEC 60068-2-2.2007, IDT) GB/T 2439 Conducting and dissipative rubbers, vulcanized or thermoplastic - Measurement of resistivity (GB/T 2439-2001, idt ISO 1853.1998) GB/T 2941 Rubber - General procedures for preparing and conditioning test pieces for physical test methods (GB/T 2941-2006, ISO 23529.2004, IDT) GB/T 3667.1 AC motor capacitors - Part 1.General - Performance, testing and rating - Safety requirements - Guide for installation and operation (GB/T 3667.1-2016, IEC 60252-1.2013, IDT) GB/T 3768 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (GB/T 3768- 2017, ISO 3746.2010, IDT) GB/T 3785.1 Electroacoustics - Sound level meters - Part 1.Specifications (GB/T 3785.1-2010, IEC 61672-1.2002, IDT) GB/T 3785.2 Electroacoustics - Sound level meters - Part 2.Pattern evaluation tests (GB/T 3785.2-2010, IEC 61672-2.2003, IDT)3 * Terminology and definitionsFor the purposes of this document, the following terms and definitions apply. 3.1 Access cover Part of an ENCLOSURE or GUARD providing the possibility of access to electrical equipment parts for the purpose of adjustment, inspection, replacement or repair. 3.2 Accessible part Part of electrical equipment other than an APPLIED PART that can be touched by means of the standard test finger.4 General requirements4.1 * Conditions for application to ME EQUIPMENT or ME SYSTEMS Unless otherwise specified, the requirements of this Part shall apply in NORMAL USE and reasonably foreseeable misuse. When applying this Part to ME EQUIPMENT or ME SYSTEMS intended for the compensation or alleviation of disease, injury or disability, the definitions and requirements that use the term PATIENT shall be considered as applying to the person for whom the ME EQUIPMENT or ME SYSTEM is intended. 4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS 4.2.1 Introduction to RISK MANAGEMENT Subclause 4.2 specifies the RISK MANAGEMENT PROCESS that is required for compliance with this Part. This RISK MANAGEMENT PROCESS is intended to serve the following purposes. a) To identify whether the normative requirements specified in Clauses 5 to 17 of this Part, together with the requirements of applicable collateral and particular standards, address all the HAZARDS associated with the particular ME EQUIPMENT or ME SYSTEM under consideration. b) To identify the way in which some particular tests specified in this Part should be applied to a particular ME EQUIPMENT or ME SYSTEM.5 * General requirements for testing ME EQUIPMENT5.1 * TYPE TESTS The tests described in this Part are TYPE TESTS. The tests to be performed are determined taking into consideration the requirements of Clause 4, in particular 4.2. A test need not be performed if analysis shows that the condition being tested has been adequately evaluated by other tests or methods. 5.2 * Number of samples TYPE TESTS are performed on a representative sample of the item being tested.6 * Classification of ME EQUIPMENT and ME SYSTEMS6.1 General For purposes of this Part, ME EQUIPMENT, or parts thereof, including APPLIED PARTS, shall be classified as follows. 6.2 * Protection against electric shock ME EQUIPMENT energized from an external electrical power source shall be classified as CLASS I ME EQUIPMENT or CLASS II ME EQUIPMENT (see 7.2.6). Other ME EQUIPMENT shall be classified as INTERNALLY POWERED ME EQUIPMENT.7 ME EQUIPMENT identification, marking anddocuments 7.1 General 7.1.1 * USABILITY of the identification, marking and documents See 12.2. 7.1.2 * Legibility of markings The markings required by 7.2, 7.3, 7.4, 7.5 and 7.6 shall be CLEARLY LEGIBLE under the following conditions. - for warning statements, instructive statements, safety signs and drawings on the outside of ME EQUIPMENT. from the intended position of the person performing the related function; - for FIXED ME EQUIPMENT. when the ME EQUIPMENT is mounted in its position of NORMAL USE; ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. |
