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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 201.10.101);
- ADD content for TRANSDUCER ASSEMBLIES (see 201.11.1.3 and
201.11.6.5);
- Modify part of the content of "Accuracy of controls and instruments and
protection against hazardous outputs" (see 201.12; 50.2, 51.2 and 51.4 of
the 2008 edition);
- ADD "Emissions, deformation of ENCLOSURE or exceeding maximum
temperature" (see 201.13.1.2);
- ADD "PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)"
(see 201.14);
- ADD "ME SYSTEMS" (see 201.16);
- Modify "Electromagnetic compatibility of ME EQUIPMENT and ME
SYSTEMS" (see 201.17; Clause 36 of the 2008 edition);
- Delete "Terms - Index of defined terms" (see Annex AA of the 2008 edition);
- Modify "Guidance and rationale for particular subclauses" (see Annex AA;
Annex BB of the 2008 edition);
- Modify "Guidance in classification according to GB 4824-2019" (see Annex
BB; Annex CC of the 2008 edition);
- Delete "Test methods for determining mechanical index and thermal index"
(see Annex DD of the 2008 edition);
- Delete "Relationship with other standards" (see Annex EE of the 2008
edition);
- Delete "Guidelines for output power measurement in scan mode" (see
Annex FF of the 2008 edition);
- Delete "Rationale and derivation of exponential model" (see Annex GG of
the 2008 edition);
- Modify "Guidance to the MANUFACTURER on the interpretation of TI and
MI to be used to inform the OPERATOR" (see Annex CC; Annex HH of the
2008 edition);
- Modify "Example set-up to measure surface temperature of externally
applied TRANSDUCER ASSEMBLIES" (see Annex DD; Annex II of the
2008 edition);
- ADD "Acoustic output table intended for 3rd parties" (see Annex EE).
This Part uses the redraft law to modify and adopt IEC 60601-2-37:2015
"Medical electrical equipment - Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment".
The technical differences between this Part and IEC 60601-2-37:2015 and their
reasons are as follows:
- As for the normative references, this Part has made adjustments with
technical differences, to adapt to the technical conditions of China. The
adjustments are reflected in Clause 2 “Normative references”. The specific
adjustments are as follows:
 ADD reference to GB 4824-2019, GB/T 6113.102-2018;
 Replace IEC 60601-1:2012 with GB 9706.1-2020, which modifies and
adopts the international standard (see 201.2);
 Replace IEC 60601-2-18:2009 with GB 9706.19, which is identical to
the international standard;
 Replace IEC 62359:2010 with YY/T 0642-2014, which is identical to the
international standard (see 201.2).
- When the standard involve a series of standards and different editions of
the same standard, and the corresponding series of standards or related
editions of standards have not been transformed in China; therefore, in
order to keep the meaning consistent with the original text, retain the
international standard number.
This Part also makes the following editorial change:
- Delete "Index of defined terms".
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Part was proposed by and shall be under the jurisdiction of National
Medical Products Administration.
Drafting organizations of this Part: Hubei Medical Devices Quality Supervision
and Test Institute; Center for Medical Device Evaluation, NMPA.
Main drafters of this Part: Wang Zhijian, Jiang Shilin, Guo Zhaojun.
Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment
The clauses and subclauses of the general standard apply except as follows:
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 * Scope
Replacement:
This standard applies to the BASIC SAFETY and ESSENTIAL
PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in
201.3.217, hereinafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME
EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause
or subclause will say so. If that is not the case, the clause or subclause applies
both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT
or ME SYSTEMS within the scope of this standard are not covered by specific
requirements in this standard except in 7.2.13 and 8.4.1 of this standard.
Note: See also subclause 4.2 of this standard.
This standard does not cover ultrasonic therapeutic equipment. Equipment
used for the imaging or diagnosis of body structures by ultrasound in
conjunction with other medical procedures is covered.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY
and ESSENTIAL PERFORMANCE requirements for ULTRASONIC
DIAGNOSTIC EQUIPMENT as defined in 201.3.217.