GB 9706.227-2021 English PDF (GB9706.227-2021)

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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
GB 9706.227-2021
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 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...