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GB 9706.202-2021: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsGB 9706.202-2021: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB9706.202-2021 GB NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 CCS C 41 Replacing GB/T 9706.4-2009 Medical electrical equipment - Part 2-2.Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2.2017, MOD) Issued on. DECEMBER 01, 2021 Implemented on. MAY 01, 2023 Issued by. General Administration of Quality Supervision, Inspection and Quarantine; Standardization Administration of the People’s Republic of China. Table of ContentsForeword... 3 Introduction... 7 1 Scope, object and related standards... 9 2 Normative references... 11 3 Terms and definitions... 11 4 General requirements... 18 5 General requirements for testing of ME EQUIPMENT... 19 6 Classification of ME EQUIPMENT and ME SYSTEMS... 20 7 ME EQUIPMENT identification, marking and documents... 20 8 Protection against electrical HAZARDS from ME EQUIPMENT... 27 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS... 47 10 Protection against unwanted and excessive radiation HAZARDS... 47 11 Protection against excessive temperatures and other HAZARDS... 47 12 Accuracy of controls and instruments and protection against hazardous outputs ... 49 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT... 56 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)... 57 15 Construction of ME EQUIPMENT... 57 16 ME SYSTEMS... 63 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS... 63 202 * ELECTROMAGNETIC DISTURBANCES - Requirements and tests... 63 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems... 64 Annexes... 65 Annex AA (informative) Particular guidance and rationale... 66 Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL EQUIPMENT... 99 Bibliography... 109ForewordThis document was drafted in accordance with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules for Standardization Documents". This document is Part 2-2 of GB 9706 “Medical electrical equipment”. GB 9706 has released the following parts. - Part 1.General requirements for safety; - 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 2-5.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 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 2-24.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 2-36.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 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 mammographie X-ray equipment and mammographie 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. This document replaces GB 9706.4-2009 “Medical electrical equipment - Part 2-2. Particular requirements for the safety of high frequency surgical equipment”. Compared with GB 9706.4-2009, except for structural adjustment and editorial changes, the main technical changes are as follows. - ADD the related content of high current mode (see 3.219, 12.4.101 of this document); - AMEND the definition of “high frequency” by adding the upper limit of frequency (see 3.220 of this document, see 2.12.108 of the 2009 edition); - ADD the relevant content of conditions for application and evaluating risk in the general requirements (see 4 of this document); - ADD additional information in instructions for use. description of neuromuscular stimulation, non-continuous activation, accessories and the maximum allowable length of accessories and cords (see 7.9.2.2.101); - AMEND the limit for high frequency leakage current of active accessories (see 8.8.3.102 of this document, see 59.103.5 of the 2009 edition); - ADD the requirement for high frequency leakage capacitance in active accessories insulation (see 8.8.3.102); - AMEND the limit for high frequency leakage current of neutral electrode cord insulation (see 15.101.4 of this document, see 59.104.4 of the 2009 edition); ADD the requirement for high frequency leakage capacitance in neutral electrode cord insulation (see 15.101.4 of this document). This document uses the redrafting method to amend and adopt IEC 60601-2-2.2017 “Medical electrical equipment - Part 2-2.Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories”. The technical differences between this document and IEC 60601-2-2.2017 and their reasons are as follows. - Regarding normative references, this document has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are concentrated in 2 “Normative references”, and the specific adjustments are as follows. ● REPLACE CISPR 11.2015 with GB 4824-2019, which is identical to the international standard; ● REPLACE IEC 60601-1-2.2014 with YY 9706.102-2021, which is modified from the international standard; ● REPLACE IEC 60601-1-8.2006 with YY 9706.108-2021, which is modified from the international standard; ● DELETE IEC 61000-4-3.2006 for non-normative reference; ● DELETE IEC 61000-4-6.2013 for non-normative reference. - AMEND Figure 107 to correspond with the textual representation of the figure; - Regarding EMC-related content, since the domestic YY 9706.102-2021 is modified from IEC 60601-1-2.2007, the content of Clause 202 and AA.202 in this document comes from 202 and AA.202 of IEC 60601-2-2.2009. The following editorial changes have been made to this document. - ADD IEC 60601-2-34.2011, GB/T 17626.3-2016, GB/T 17626.6-2017 and CISPR 11 to the bibliography; - DELETE the index of defined terms of the international standard. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. The previous versions of this document and its superseded documents are as follows. - It is first published in 1992 as GB 9706.4-1992, first revised in 1999, second revised in 2009; - This is the third revision, and the document number is changed to GB 9706.202- 2021.1 Scope, object and related standardsClause 1 of the general standard 1 applies, except as follows.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. Clause 2 of the general standard applies, except as follows.3 Terms and definitionsFor the purposes of this document, the terms and definitions given in the general standard and the following apply.4 General requirementsClause 4 of the general standard applies, except as follows.5 General requirements for testing of ME EQUIPMENTClause 5 of the general standard applies, except as follows.6 Classification of ME EQUIPMENT and ME SYSTEMSClause 6 of the general standard applies.7 ME EQUIPMENT identification, marking and documentsClause 7 of the general standard applies, except as follows.8 Protection against electrical HAZARDS from MEEQUIPMENT Clause 8 of the general standard applies, except as follows.9 Protection against MECHANICAL HAZARDS of MEEQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies.10 Protection against unwanted and excessive radiationHAZARDS Clause 10 of the general standard applies.11 Protection against excessive temperatures and otherHAZARDS15 Construction of ME EQUIPMENTClause 15 of the general standard applies, except as follows. 15.4.1 Construction of connectors Additional subclauses.202 * ELECTROMAGNETIC DISTURBANCES - Requirements and testsYY 9706.102-2021 applies except as follows. 202.6.1 EMISSIONS 202.6.2 IMMUNITY ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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