YY 9706.278-2023 English PDFUS$1139.00 · In stock
Delivery: <= 8 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.278-2023: Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation Status: Valid
Basic dataStandard ID: YY 9706.278-2023 (YY9706.278-2023)Description (Translated English): Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C30 Classification of International Standard: 11.040.01 Word Count Estimation: 60,631 Date of Issue: 2023-03-14 Date of Implementation: 2026-05-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies the basic safety and basic performance of medical robots that are expected to have physical contact with patients and realize the rehabilitation, assessment, compensation or mitigation of patient limb motor functions. This document is applicable to medical robots that are expected to have physical contact with patients, and realize the rehabilitation, assessment, compensation or relief of the patient's limb motor function. This document does not apply to prosthetics and orthotics, wheelchair vehicles, diagnostic imaging devices, and personal assistant robots. YY 9706.278-2023: Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. ICS11:040:01 CCSC30 Pharmaceutical Industry Standard of the People's Republic of China Medical Electrical Equipment Part 2-78: Rehabilitation, Evaluation, Compensating or mitigating the basic safety and Basic performance-specific requirements (IEC 80601-2-78:2019, MOD) Released on 2023-03-14 2026-05-01 Implementation Released by the State Drug Administration table of contentsPreface I Introduction II 201:1 Scope 1 201:2 Normative references 2 201:3 Terms and Definitions 2 201:4 General requirements 5 201:5 General requirements for testing of ME EQUIPMENT 6 201:6 Classification of me equipment and me systems6 201:7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 6 201:8 Protection against electric shock hazards for ME EQUIPMENT7 201:9 *Protection of me equipment and me systems against mechanical risks7 201:10 Protection against unwanted or excessive radiation hazards (sources)12 201:11 Protection against extreme temperatures and other hazards (sources)12 201:12 Accuracy of controls and instruments and protection against hazardous outputs12 201:13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 13 201:14 Programmable electrical medical systems (PEMS) 13 201:15 Construction of ME EQUIPMENT 13 201:16 *ME system 15 201:17 *Electromagnetic Compatibility of ME EQUIPMENT and ME SYSTEMS 15 202 Electromagnetic Compatibility --- Requirements and Tests 15 206 Availability 15 208 *General requirements, tests and guidance for alarm systems in me equipment and me systems 15 210 *Requirements for the development of physiological closed-loop controllers 16 211 * Requirements for ME EQUIPMENT and ME SYSTEMS used in the home care environment 16 Appendix A (Informative) Rationale for General Guidelines 18 Appendix AA (Informative) Special Guidance and Rationale 19 Appendix BB (Informative) Guidance and Examples for Situational Awareness 41 Reference 52 Index 54forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: The "Medical Electrical Equipment" series of standards are divided into two parts: --- Part 1: General and parallel requirements; --- Part 2: Special requirements: This document is Part 2-78: This document is modified to adopt IEC 80601-2-78:2019 "Medical Electrical Equipment Part 2-78: Rehabilitation, Assessment, Compensation or Palliative Medicine Special Requirements for Basic Safety and Basic Performance of Robots": The technical differences between this document and IEC 80601-2-78:2019 and their reasons are as follows: --- Regarding the normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustments The situation is reflected in:201:2 "Normative reference documents", the specific adjustments are as follows: ● Replace IEC 60601-1:2005 AMD1:2012 with GB 9706:1-2020, which adopts the revised international standard; ● Replace ISO 14971:2007 with YY/T 0316-2016, which is equivalent to the international standard; ● Replace IEC 60601-1-2:2014 with YY 9706:102-2021, which adopts the international standard; ● Replace IEC 60601-1-6:2010 AMD1:2013 with YY/T 9706:106-2021, which adopts international standards; ● Replace IEC 60601-1-8:2006 AMD1:2012 with YY 9706:108-2021, which adopts international standards; ● Replace IEC 60601-1-10:2007 A1:2013 with YY/T 9706:110-2021, which adopts international standards; ● Replace IEC 60601-1-11:2015 with YY 9706:111-2021, which adopts the revised international standard; ● Added normative reference document YY/T 1474; ● Deleted the normative reference document IEC 62366-1:2015; ● The normative reference to ISO 22523:2006 has been deleted: ---Deleted the supplementary content of 202:4:2:3:1, Chapter 202 was revised to "YY 9706:102-2021 applies": The reason is that the original English The content of 202:4:2:3:1 in the article already exists in YY 9706:102-2021: --- Deleted 206:4:2 and 206:5 and the corresponding content of the appendix: Modifications to IEC 60601-1-6 in the original text of IEC are limited to changes The version number of the referenced standard and the addition of informative notes to the new version of the referenced standard, after deletion, are preserved with YY/T 9706:106-2021 Be consistent: The following editorial changes have been made to this document: ---Replace the informative referenced ISO 22523 with the Chinese standard GB/T 30659; --- Added reference IEC 62366-1:2015: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on:IntroductionSafety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute: ---General standard: The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements: --- Parallel standards: safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards: ---Special standards: Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard: ---Guidelines and interpretations: application guidelines and explanations for the relevant requirements of the standards involved: This document modifies and supplements GB 9706:1-2020 "Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance Request", hereinafter referred to as the general standard: Appendix AA contains a rationale for some of the requirements, which includes the background and reasons for certain requirements, and the identification of related issues that need to be addressed: danger: An asterisk (*) used in this document as the first character of a heading or at the beginning of a paragraph or table heading indicates that there is a Specific guides and rationale for this project: Medical Electrical Equipment Part 2-78: Rehabilitation, Evaluation, Compensating or mitigating the basic safety and Basic performance-specific requirements 201:1 Scope Except as described below, Chapter 1 of the general standard applies: 201:1:1 Scope replace: This document specifies the medical equipment intended to produce physical contact with the patient, to achieve the rehabilitation, assessment, compensation or alleviation of the motor function of the patient's limbs: Basic safety and basic performance of the robot: This document applies to medical devices that are expected to have physical contact with patients and to achieve rehabilitation, assessment, compensation or relief of patient motor functions robot: If a clause or clause expressly applies only to me equipment or me systems, the title and text of the clause or clause shall state so: if not In this case, the relevant chapter or subclause applies to both ME EQUIPMENT and ME SYSTEM: Note: Refer to 4:2 of the general standard: This document does not apply to: --- Prosthetics and orthotics (GB/T 30659); ---Wheelchair (GB/T 18029 series standard); ---Diagnostic imaging equipment (such as magnetic resonance equipment, YY 9706:233); --- Personal assistant robot (GB/T 36530): 201:1:2 Purpose replace: The purpose of this document is to establish specific basic safety and essential performance requirements for the aforementioned medical robots: 201:1:3 * Collateral Standard Supplement: This document refers to Chapter 2 of the General Standard as well as applicable collateral standards listed in:201:2 of this document: 201:1:4 Particular standards replace: In the 9706 series of standards, specific standards may modify, replace or delete general standards and collateral standards according to the specific me equipment under consideration: requirements contained in the standards: And other basic safety and basic performance requirements may be supplemented: Particular standard requirements take precedence over general standards: In this document, GB 9706:1-2020 is called the general standard: Collateral standards are indicated by their respective document numbers: The numbers of chapters and clauses in this document correspond to general standards by adding the prefix "201" (for example,:201:1 in this document corresponds to general standard No: 1 Chapter), or correspond to the applicable Collateral Standard by prefixing "20×", where X is the last digit of the corresponding document number (e:g: ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.278-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.278-2023_English as soon as possible, and keep you informed of the progress. 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