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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
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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 Contents
Foreword... 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... 85
Foreword
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.
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 Tests
YY 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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