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GB 9706.227-2021: Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment 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 standardsGB 9706.227-2021: Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment---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/GB9706.227-2021 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.050 CCS C 39 Replacing GB 9706.25-2005 Medical Electrical Equipment - Part 2-27.Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment (IEC 60601-2-27.2011, MOD) Issued on. OCTOBER 11, 2021 Implemented on. MAY 1, 2023 Issued by. State Administration for Market Regulation; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 7 201.1 Scope, Object and Related Standards... 9 201.2 Normative References... 11 201.3 Terms and Definitions... 11 201.4 General Requirements... 13 201.5 General Requirements for Testing of ME EQUIPMENT... 14 201.6 Classification of ME EQUIPMENT and ME SYSTEMS... 15 201.7 ME EQUIPMENT Identification, Marking and Documents... 15 201.8 Protection against Electrical HAZARDS from ME EQUIPMENT... 20 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS... 26 201.10 Protection against Unwanted and Excessive Radiation HAZARDS... 27 201.11 Protection against Excessive Temperatures and Other HAZARDS... 27 201.12 Accuracy of Controls and Instruments and Protection against Hazardous Outputs... 29 201.13 HAZARDOUS SITUATIONS and Fault Conditions... 50 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 50 201.15 Construction of ME EQUIPMENT... 51 201.16 ME SYSTEMS... 52 201.17 Electromagnetic Compatibility of ME EQUIPMENT and ME SYSTEMS... 52 202 Electromagnetic Compatibility – Requirements and Tests... 52 202.6 ELECTROMAGNETIC COMPATIBILITY... 52 208 General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems... 58 208.6 ALARM SYSTEMS... 58 Annexes... 67 Annex AA (Informative) Particular Guidance and Rationale... 68 Annex BB (Informative) Alarm Diagrams of Clause 208/YY 9706.108-2021... 82 Bibliography... 85ForewordThis 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. This Document is Part 2-27 of GB 9706 Medical Electrical Equipment. GB 9706 has published 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 in diagnostic X-ray equipment; --- Part 2-1.Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV; --- Part 2-2.Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; --- Part 2-3.Particular requirements for the basic safety and essential performance of short- wave therapy equipment; --- Part 2-4.Particular requirements for the basic safety and essential performance of cardiac defibrillators; --- Part 2-5.Particular requirements for the basic safety and essential performance 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 the 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 the basic safety and essential performance of an anaesthetic workstation; --- Part 2-16.Particular requirements for the basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration 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 basic safety and essential performance 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 electroencephalographs; --- 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 basic safety and essential performance of peritoneal dialysis equipment; --- Part 2-43.Particular requirements for the basic safety and essential performance 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 basic safety and essential performance 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 Document replaced GB 9706.25-2005 Medical Electrical Equipment - Part 2.Particular Requirements for the Safety of Electrocardiographic Monitoring Equipment. Compared with GB 9706.25-2005, the major technical changes of this Document are as follows besides the structural adjustments and editorial modifications. --- Integrate all the contents of YY 1079-2008; --- Add energy reduction test (see 201.8.5.5.2); --- Add performance requirements (see 201.12.1), and specify basic performance (see Table 201.101); --- Add EMC requirements (see 202); --- Add alarm requirements (see 208); --- Change the experimental circuit diagram of the defibrillation protection effect (see Figure 201.102, Figure 201.103 of this Edition; Figure 104, Figure 105 of the 2005 Edition); --- Delete the requirement for electrode polarization recovery time after defibrillation (see 51.102 of the 2005 Edition). This Document used the redrafting method to modify and adopt IEC 60601-2-27.2011 Medical Electrical Equipment – Part 2-27.Particular Requirements for the Basic Safety and Essential Performance of Electrocardiographic Monitoring Equipment. The technical differences and causes between this Document and IEC 60601-2-27.2011 are as follows. --- Regarding normative references, this Document has been adjusted with technical differences to adapt to China's technical conditions. The adjustments are reflected in 201.2 "Normative References". The specific adjustments are as follows. ● Use GB 9706.202 that modified and adopted international standard to replace IEC 60601-2-2.2009; ● Use YY 9706.102-2021 that modified and adopted international standard to replace IEC 60601-1-2.2007; ● Use YY 9706.108-2021 that modified and adopted international standard to replace IEC 60601-1-8.2008; ● Add GB/T 4208-2017; ● Delete IEC 60601-2-49. This Document made the following editorial modifications. --- Incorporate the contents of the technical corrigendum IEC 60601-2-27.2011/COR1.2012; and indicate it with a vertical double line (‖) in the outer blank position of the corresponding clause; --- Modify the editorial error; and change the value of "pulse burst interval b, c (tb)" in the third column of "Low priority alarm signal" in Table 208.102 into "2.5s~30s"; --- Delete terminology index. 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 and under the jurisdiction of National Medical Products Administration. The historical editions replaced by this Document are as follows. --- GB 9706.25-2005 was first-time published in 2005; --- It is first-time revised hereby. 201.1 Scope, Object and Related Standards Clause 1 of the general standard applies, except as follows. 201.2 Normative References The following documents are essential to the application of 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. 201.4 General Requirements Clause 4 of the general standard applies, except as follows. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies, except as follows. 201.7 ME EQUIPMENT Identification, Marking and Documents Clause 7 of the general standard applies, except as follows. 201.8 Protection against Electrical HAZARDS from ME EQUIPMENT Clause 8 of the general standard applies, except as follows. 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201.10 Protection against Unwanted and Excessive Radiation HAZARDS Clause 10 of the general standard applies. 201.11 Protection against Excessive Temperatures and Other HAZARDS Clause 11 of the general standard applies, except as follows. 201.12 Accuracy of Controls and Instruments and Protection against Hazardous Outputs Clause 12 of the general standard applies, except as follows. 201.13 HAZARDOUS SITUATIONS and Fault Conditions Clause 13 of the general standard applies. 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) Clause 14 of the general standard applies. 201.15 Construction of ME EQUIPMENT Clause 15 of the general standard applies, except as follows. 201.16 ME SYSTEMS Clause 16 of the general standard applies. 201.17 Electromagnetic Compatibility of ME EQUIPMENT and ME SYSTEMS Clause 17 of the general standard applies, except as follows.202 Electromagnetic Compatibility – Requirements and TestsYY 9706.102-2021 applies except as follows. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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