GB 9706.237-2020Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (English PDF)

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.

The previous editions of the standard replaced by this Part were released as

follows.

- GB 6385-1986;

- GB 9706.9-1997, GB 9706.9-2008.