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

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; 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:
Medical Electrical Equipment - Part 2-27: Particular
Requirements for the Basic Safety and Essential
Performance of Electrocardiographic Monitoring
Equipment
201.1 Scope, Object and Related Standards
Clause 1 of the general standard applies, except as follows:
201.1.1 *Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in this
Document and hereinafter also referred to as ME EQUIPMENT.
This Document applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This Document also applies to ECG telemetry systems used in a hospital environment.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this Document. Additional standards may apply to ME EQUIPMENT for those environments of use.
This Document is not applicable to electrocardiographic monitors for home use. However, MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this Document.
201.1.2 Object
Replacement:
The object of this Document is to establish BASIC SAFETY and ESSENTIAL
PERFORMANCE requirements for ELECTROCARDIOGRAPHIC (ECG) MONITORING
EQUIPMENT as defined in 201.3.63.
to-valley sinusoidal signal between the R (RA) and L (LA) LEAD WIRES.
For PERMANENT DISPLAYS, the GAIN setting of 10 mm/mV shall produce a displayed signal amplitude of (10±1.0) mm. Adjust the input signal amplitude if the displayed signal is saturated or too small to measure, Measure the displayed signal amplitude for all implemented fixed GAIN settings. Verify that the displayed signal amplitude is within 10 % of the chosen GAIN setting.
For NON-PERMANENT DISPLAYS, repeat this test for all implemented fixed GAIN settings. Measure the displayed signal amplitude. Verify that the resulting value is within 10% of the chosen GAIN setting.
The GAIN change one minute after energizing the ME EQUIPMENT shall not exceed 0.66 % per minute. The total GAIN change shall not exceed±10 % for periods of 1 min, 5 min, 30 min and 60 min
Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers accurate to within 0.2 mm.
After stabilizing at ambient temperature, energize the ME EQUIPMENT. Set the GAIN to 10 mm/mV and sweep speed to 25 mm/s. Apply a 1 mV peak-to-valley 10 Hz signal. Measure the displayed output amplitude after 1 min, 5 min, 30 min and 60 min. Verify that the displayed output amplitude varies less than ±1 mm between any measurements or 0.66 % per minute. Other fix GAIN settings may be used to determine the GAIN stability of NON-PERMANENT DISPLAYS. In this case verify that the displayed output amplitude varies less than ±1 mm multiplied by factor ‘selected fix GAIN divided by 10 mm/mV’ between any measurements or 0.66 % per minute.
201.12.1.101.7 Sweep speed
ME EQUIPMENT with PERMANENT DISPLAYS shall provide at least one sweep speed of 25×(1±10%) mm/s. ME EQUIPMENT with NON-PERMANENT DISPLAYS shall provide at least one sweep speed that is labelled 25 mm/s and has a waveform aspect ratio as specified in 201.12.1.101.16 at a GAIN setting of 10 mm/mV.
Other sweep speeds may be provided. The MANUFACTURER shall disclose all available sweep speeds [see 201.7.9.2.9.101 b) 12]. The sweep speed accuracy for any settings shall not vary by more than ±10 % over the complete horizontal ECG-channel width. Compliance is checked using the test circuit of Figure 201.105 and a ruler or callipers accurate to within 0.2 mm.
Connect a signal generator between the R (RA) LEAD WIRE and all other LEAD WIRES connected to the N (RL) LEAD WIRE. Set the GAIN to 10 mm/mV and the sweep speed to 25 mm/s. Apply a 0.5 mV peak-to-valley triangular or sinusoidal signal of 25×(1±1 %) Hz.
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