GB 9706.237-2020 English PDF (GB9706.237-2020)

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GB 9706.237-2020: Medical electrical equipment -- Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
GB 9706.237-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.55; 17.140.50
C 41
Replacing GB 9706.9-2008
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
(IEC 60601-2-37:2015, MOD)
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 4
Introduction ... 10
201.1 Scope, object and related standards ... 11
201.2 Normative references ... 13
201.3 Terms and definitions ... 13
201.4 General requirements ... 22
201.5 General requirements for testing ME EQUIPMENT ... 23
201.6 Classification of ME EQUIPMENT and ME SYSTEMS ... 23
201.7 ME EQUIPMENT identification, marking and documents ... 23
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ... 28
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and
ME SYSTEMS ... 29
201.10 Protection against unwanted and excessive radiation HAZARDS ... 29
201.11 Protection against excessive temperatures and other HAZARDS ... 29
201.12 Accuracy of controls and instruments and protection against hazardous
outputs ... 35
201.13 Hazardous situations and fault conditions of ME EQUIPMENT ... 38
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 38
201.15 Construction of ME EQUIPMENT ... 38
201.16 ME SYSTEMS ... 38
201.17* Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
... 39
202.6 ELECTROMAGNETIC COMPATIBILITY ... 39
Annexes ... 43
Annex AA (Informative) Guidance and rationale for particular subclauses ... 44
Annex BB (Informative) Guidance in classification according to GB 4824-2019
... 52
Annex CC (Informative) Guidance to the MANUFACTURER on the
interpretation of TI and MI to be used to inform the OPERATOR ... 53
Annex DD (Informative) Example set-up to measure surface temperature of
externally applied TRANSDUCER ASSEMBLIES ... 57
Annex EE (Informative) Acoustic output table intended for 3rd parties ... 60
Bibliography ... 63
Foreword
All technical content of this Part is mandatory.
GB 9706 "Medical electrical equipment" is divided into 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: General requirements for radiation protection in
diagnostic X-ray equipment;
- Part 2-1: Particular requirements for the safety of electron accelerators in
the range 1 MeV to 50 MeV;
- Part 2-2: Particular requirements for the safety of high frequency surgical
equipment;
- Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave therapy equipment;
- Part 2-4: Particular requirements for the safety of cardiac defibrillators;
- Part 2-5: Particular requirements for the safety 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 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 basic safety and essential
performance of an anaesthetic workstation;
- Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration 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 safety 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 electroencephalograph;
- 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 the safety of peritoneal dialysis
equipment;
- Part 2-43: Particular requirements for the safety 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 safety 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 Part is Part 2-37 of GB 9706.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB 9706.9-2008 "Medical electrical equipment - Part 2-37:
Particular requirements for the safety of ultrasonic medical diagnostic and
monitoring equipment".
Compared with GB 9706.9-2008, the main technical changes in this Part are as
follows:
- ADD "Scope" (see 201.1.1);
- ADD "Object" (see 201.1.2);
- ADD "Normative references" (see 201.2);
- Modify "Terms and definitions" (see 201.3; Clause 2 of the 2008 edition);
- ADD content related to ULTRASOUND ENDOSCOPE (see 201.4.1);
- ADD "Additional ESSENTIAL PERFORMANCE requirements" (see
201.4.3.101);
- Modify part of the content of "ME EQUIPMENT identification, marking and
documents" (see 201.7; Clause 6 of the 2008 edition);
- ADD "Acoustic output" (see 201.7.2.101);
- ADD "Technical data regarding acoustic output levels" (see 201.7.9.3.101);
- ADD content for TRANSDUCER ASSEMBLIES (see 201.8.7.4.7,
201.8.7.4.8, 201.8.8.3, 201.8.9.3.4 and 201.8.10.4);
- ADD "Ultrasonic energy" (see...