GB 9706.237-2020 PDF English

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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
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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

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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. 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. 201.1 Scope, object and related standards Clause 1 of the general standard applies, except as follows. 201.2 Normative references Clause 2 of the general standard applies except as follows. Addition. 201.3 Terms and definitions For the purposes of this document, the terms and definitions given in the general standard and in YY/T 0642-2014, as well as the following additions apply. 201.4 General requirements Clause 4 of the general standard applies except as follows. 201.5 General requirements for testing ME EQUIPMENT Clause 5 of the general standard applies. 201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies. 201.7 ME EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows. 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies. 201.10 Protection against unwanted and excessive radiation HAZARDS Clause 10 of the general standard applies except as follows. 201.15 Construction of ME EQUIPMENT Clause 15 of the general standard applies. 201.16 ME SYSTEMS Clause 16 of the general standard applies. 201.17* Electromagnetic compatibility of ME Clause 17 of the general standard applies except as follows. Addition. 202.6 ELECTROMAGNETIC COMPATIBILITY "ELECTROMAGNETIC COMPATIBILITY" of YY 0505 applies, except as follows. 202.6.1.1 Protection of radio services ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.

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