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YY 9706.262-2021: Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment 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 standardsYY 9706.262-2021: Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound(HITU) equipment---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/YY9706.262-2021 PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.50 C 41 Medical Electrical Equipment – Part 2-62.Particular Requirements for the Basic Safety and Essential Performance of High Intensity Therapeutic Ultrasound (HITU) Equipment (IEC 60601-2-62.2013, MOD) Issued on. MARCH 09, 2021 Implemented on. MAY 01, 2023 Issued by. National Medical Products Administration Table of ContentsForeword... 3 Introduction... 5 201.1 Scope, Object and Collateral Standards... 6 201.2 Normative References... 8 201.3 Terms and Definitions... 9 201.4 General Requirements... 24 201.5 General Requirements for Testing of ME EQUIPMENT... 26 201.6 Classification of ME EQUIPMENT and ME SYSTEMS... 26 201.7 ME EQUIPMENT Identification, Marking and Documents... 26 201.8 Protection against Electrical HAZARDS from ME EQUIPMENT... 29 201.9 Protection against Mechanical Hazards of ME EQUIPMENT and ME SYSTEMS ... 30 201.10 Protection against Unwanted and Excessive Radiation HAZARDS... 30 201.11 Protection against excessive temperatures and other HAZARDS... 33 201.12 Accuracy of controls and instruments and protection against hazardous outputs ... 34 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT.. 36 201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS)... 36 201.15 Construction of ME EQUIPMENT... 37 201.16 ME systems... 37 201.17 * Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 37 202 Electromagnetic Compatibility – Requirements and Tests... 37 Annexes... 42 Annex AA (Informative) Particular Guidance and Rationale... 42 Annex BB (Informative) Targeting... 47 Annex CC (Informative) HITU - Specific Risks... 51 Annex DD (Informative) Determining Regions of HITU Fields for Measurement... 56 Annex EE (Informative) Guidance in classification according to GB 4824-2019... 69 Annex FF (Informative) Notes on Using a Saline or Water Bath for EMI Testing... 70 Bibliography... 73ForewordAll the technical contents of this Part are mandatory. Medical Electrical Equipment serial standards are divided into two parts. --- Part 1.General and Collateral Requirements; --- Part 2.Particular Requirements. This Part is Part 2-62. This Part was drafted as per the rules specified in GB/T 1.1-2009. This Part uses the redrafting method to modify and adopt IEC 60601-2-62.2013 Medial Electrical Equipment – Part 2-62.Particular Requirements for the Basic Safety and Essential Performance of High Intensity Therapeutic Ultrasound (HITU) Equipment. The technical differences and the causes between this Part and IEC 60601-2-62.2013 are as follows. --- Regarding Normative References, this Part has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are concentrated in Clause 2, "Normative References". The specific adjustments are as follows. Use YY/T 0642 that equivalently adopts the international standard to replace IEC 62359 (see 201.2); Use YY/T 0750-2018 that modifies and adopts the international standard to replace IEC 61689.2013 (see 201.2); Use YY/T 0865.1 that equivalently adopts the international standard to replace IEC 62127-1 (see 201.2); Use YY/T 0865.2 that equivalently adopts the international standard to replace IEC 62127-2 (see 201.2). This Part made the following editorial modifications as follows. --- Deleted the content of reference [3-10] mentioned in the NOTE of the Normative References; --- According to the numbering rules for annexes in the text of the Standard, modify Annex A to Annex AA; --- According to the numbering rules for annexes in the text of the Standard, modify Annex D to Annex DD; --- Add some NOTE to this Part. Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Part was proposed by National Medical Products Administration. This Part shall be under the jurisdiction of Subcommittee of Medical Ultrasound Equipment of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10/SC 2). Drafting organizations of this Part. Hubei Institute of Medical Device Quality Supervision and Testing; Chongqing Haifu Medical Technology Co., Ltd.; and Wuxi Haiying Electronic Medical System Co., Ltd. Chief drafting staffs of this Part. Jiang Shilin, Ye Fangwei, Wang Guoying, and Xu Yang. 201.1 Scope, Object and Collateral 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. Replacement. 201.3 Terms and Definitions For the purposes of this Document, the terms and definitions given in GB 9706.1, YY/T 0642, YY/T 0865.1 and YY/T 0750 and the following apply. 201.4.11 POWER INPUT Addition. This clause of the general standard applies with EQUIPMENT operated at maximum OUTPUT POWER. 201.5 General Requirements for Testing of ME EQUIPMENT Clause 5 of the general standard applies, except as follows. 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. Addition. 201.8 Protection against Electrical HAZARDS from ME EQUIPMENT Clause 8 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. 201.11 Protection against excessive temperatures and other HAZARDS Clause 11 of the general standard applies, except as follows. 201.12 Accuracy of controls and instruments and protection against hazardous outputs Clause 12 of the general standard applies, except as follows. 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT Addition. 201.14 Programmable ELECTRICAL MEDICAL SYSTEMS (PEMS) Clause 14 of the general standard applies 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 EQUIPMENT and ME SYSTEMS Clause 17 of the general standard applies except as follows. Addition.202 Electromagnetic Compatibility – Requirements and TestsYY 9706.102 applies, except as follows. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 9706.262-2021 be delivered?Answer: The full copy PDF of English version of YY 9706.262-2021 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 9706.262-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY 9706.262-2021_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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