GB 9706.227-2021Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (English PDF)

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

202 Electromagnetic Compatibility – Requirements and Tests

YY 9706.102-2021 applies except as follows.

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