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GB/T 9706.266-2025: Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems
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GB/T 9706.266-2025: Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

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ICS 11.040.99 CCSL31 National Standards of the People's Republic of China Medical electrical equipment Parts 2-66.Hearing aids and related equipment Basic safety and basic performance requirements for hearing systems (IEC 60601-2-66.2019, MOD) Published on 2025-12-31 Implemented on July 1, 2026 State Administration for Market Regulation The State Administration for Standardization issued a statement.

Table of contents

Preface III Introduction V 201.1 Scope, Purpose, and Relevant Standards 1 201.2 Normative References 2 201.3 Terms and Definitions 3 201.4 General Requirements 4 201.5 General Requirements for ME Equipment Testing 5 201.6 Classification of ME devices and ME systems 6 201.7 ME Equipment Identification, Marking and Documentation 6 201.8 *ME equipment protection against electric shock hazard 11 201.9 *Mechanical Hazard Protection for ME Equipment and Systems 13 201.10 *Protection against unnecessary or excessive radiation hazards (sources) 15 201.11 *Protection against overheating and other hazards (sources) 15 201.12 *Accuracy of controllers and instruments and protection against hazardous outputs 16 201.13 *ME Equipment Hazardous Conditions and Fault Status 17 201.14 *Programmable Medical Electrical Systems (PEMS) 19 201.15 *ME equipment structure 20 201.16 *ME System 21 201.17 Electromagnetic compatibility of ME equipment and ME systems 22 Appendix 23 Appendix E (Informative) Example of connection of measuring device (MD) for measuring patient leakage current and patient auxiliary current 24 Appendix G (Normative) Protection against ignition hazards (sources) of flammable anesthetic gas mixtures 25 Appendix H (Informative) PEMS Structure, PEMS Development Lifecycle, and Documentation 26 Appendix I (Informative) ME System Aspects 27 Appendix J (Informative) Insulation Path Investigation 28 Appendix K (Informative) Simplified Diagram of Patient Leakage Current 29 Appendix L (Normative) Winding wires without padding insulation 30 Appendix AA (Informative) Special Guidelines and Explanations of Principles 31 Appendix BB (Informative) Index of Alphabetical Abbreviations 35 Appendix CC (Informative) Basic Performance 36 Appendix DD (Informative) Electromagnetic Compatibility of ME Equipment 37 References 38

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents". Drafting. This document is Part 2-66 of GB (/T) 9706 "Medical Electrical Equipment". GB (/T) 9706 has already published the following parts. ---Part 1.General requirements for basic safety and basic performance; ---Parts 1-3.General requirements for basic safety and basic performance (parallel standard). Radiation protection for diagnostic X-ray equipment; ---Part 2-1.Basic Safety and Performance Requirements for Electron Accelerators with Energy from 1 MeV to 50 MeV; ---Part 2-2.Basic safety and performance requirements for high-frequency surgical equipment and accessories; ---Parts 2-3.Basic safety and fundamental performance requirements for shortwave therapy equipment; ---Parts 2-4.Basic safety and basic performance requirements for cardiac defibrillators; ---Parts 2-5.Basic safety and performance requirements for ultrasound therapy equipment; ---Parts 2-6.Basic safety and performance requirements for microwave therapy equipment; ---Parts 2-8.Basic safety and fundamental performance requirements for therapeutic X-ray devices with energies from 10 kV to 1 MV; ---Part 2-11.Basic safety and fundamental performance requirements for gamma beam therapy equipment; ---Part 2-12.Specific requirements for basic safety and performance of intensive care ventilators; ---Part 2-13.Specific requirements for basic safety and performance of anesthesia workstations; ---Part 2-16.Basic safety and fundamental performance requirements for hemodialysis, hemodiafiltration, and hemofiltration equipment; ---Part 2-17.Basic safety and performance requirements for automated brachytherapy afterloading devices; ---Part 2-18.Basic safety and fundamental performance requirements for endoscopic devices; ---Part 2-19.Specific requirements for basic safety and performance of infant incubators; ---Part 2-22.Basic safety and fundamental performance requirements for laser devices used in surgery, plastic surgery, therapeutic and diagnostic applications; ---Part 2-24.Basic safety and fundamental performance requirements for infusion pumps and infusion controllers; ---Part 2-25.Special requirements for basic safety and basic performance of electrocardiographs; ---Part 2-26.Special requirements for basic safety and performance of electroencephalographs; ---Part 2-27.Special requirements for basic safety and basic performance of electrocardiogram monitoring equipment; ---Part 2-28.Basic safety and performance requirements for medical diagnostic X-ray tube assemblies; ---Part 2-29.Basic safety and fundamental performance requirements for radiotherapy simulators; ---Parts 2-36.Basic safety and performance requirements for in vitro lithotripsy equipment; ---Part 2-37.Basic safety and essential performance requirements for ultrasound diagnostic and monitoring equipment; ---Part 2-39.Special requirements for basic safety and basic performance of peritoneal dialysis equipment; ---Part 2-43.Basic safety and performance requirements for interventional X-ray equipment; ---Parts 2-44.Basic safety and performance requirements for X-ray computed tomography equipment; ---Parts 2-45.Basic Safety and Performance of Mammography Equipment and Mammography Stereotactic Devices Require; ---Parts 2-54.Basic safety and fundamental performance requirements for X-ray radiography and fluoroscopy equipment; ---Part 2-55.Special requirements for basic safety and basic performance of respiratory gas monitors; ---Part 2-60.Special requirements for basic safety and basic performance of dental devices; ---Part 2-63.Special requirements for basic safety and basic performance of extraoral imaging dental X-ray machines; ---Part 2-65.Basic safety and fundamental performance requirements for intraoral imaging dental X-ray machines; ---Part 2-66.Basic safety and basic performance requirements for hearing aids and hearing aid systems; ---Part 2-71.Fundamental safety and fundamental performance requirements for functional near-infrared spectroscopy (NIRS) devices; ---Part 2-75.Basic safety and fundamental performance requirements for photodynamic therapy and photodynamic diagnostic equipment; ---Part 2-83.Basic safety and basic performance requirements for home-use phototherapy devices; ---Part 2-90.Basic safety and basic performance requirements for high-flow respiratory therapy equipment. This document is modified to adopt IEC 60601-2-66.2019 "Medical electrical equipment – Part 2-66.Hearing aids and hearing aid systems" "Specific requirements for safety and basic performance". The technical differences between this document and IEC 60601-2-66.2019, and the reasons therefor, are as follows. ---Regarding normative references, this document has made adjustments to reflect technical differences in order to adapt to my country's technical conditions. The adjustments are as follows. This is primarily reflected in section.201.2, "Normative References," with the specific adjustments as follows. ● YY9706.102 replaces IEC 60601-1-2.2014 (see.201.2,.201.17, and Appendix DD); ● GB 4943.1 replaces IEC 60950-1.2005, IEC 60950-1.2005/AMD1.2009, and IEC 60950-1. 2005/AMD2.2013 and IEC 62368-1.2018 (see.201.1.1,.201.2,.201.8.1,.201.8.2.1,...). 201.15.3.1,.201.15.4.4, Appendix AA); ● GB/T 25102.100 replaces IEC 60118-0.2015 (see.201.2,.201.3.204,.201.3.205,.201.7.9). 3.1 (Appendix AA, Appendix DD) ● GB/T 25102.13 has replaced IEC 60118-13 (see.201.2,.201.17, and Appendix DD); ● GB 9706.1-2020 has replaced IEC 60601-1.2005 and IEC 60601-1.2005/AMD1.2012 (see GB 9706.1-2020). 201.2,.201.8.1, Appendix AA); ● YY9706.111-2021 replaces IEC 60601-1-11.2015 (see.201.2,.201.5.9.2.1, and Annex AA); ● Added normative reference document YY/T 0664 (see.201.2); ● Added normative reference document YY/T 9706.106 (see.201.2,.201.7.9.1,.201.12.2). The following editorial changes have been made to this document. ---IEC 60118-4 has been replaced with GB/T 25102.4, which is used for informational purposes. ---IEC 60645-1 has been replaced with GB/T 7341.1, which is used for informational purposes. ---IEC 60601-1-3 has been replaced with GB 9706.103, which is used for informational purposes. ---IEC 60601-1-10 has been replaced with YY/T 9706.110, which is used for informational reference. ---IEC 60318-5 has been replaced with GB/T 25498.5, which is used for informational purposes. ---IEC 61672-1 has been replaced with GB/T 3785.1, which is used for informational purposes. ---IEC 60695-11-10 has been replaced with GB/T 5169.16, which is used for informational purposes. ---CISPR11 has been replaced with GB 4824, which is cited as an informative reference; ---IEC 60529 has been replaced with GB/T 4208, which is used for informational purposes. ---ISO 15223-1 has been replaced by YY/T 0466.1, which is used for informational purposes. ---IEC 61000-4-2 and IEC 61000- have been replaced by the informative references GB/T 17626.2 and GB/T 17626.8, respectively. 4-8; ---Note in.201.2 has been deleted; ---The abbreviations CD, NSH, NWIP, and OSHA have been removed from Appendix BB; ---The term index at the end of the text has been removed. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the Ministry of Industry and Information Technology of the People's Republic of China. This document is under the jurisdiction of the National Electroacoustics Standardization Technical Committee (SAC/TC23). This document was drafted by. Jiangsu Provincial Institute for Medical Device Testing, the Third Research Institute of China Electronics Technology Group Corporation, and Sonova Hearing Technology. (Shanghai) Co., Ltd., Widex Sivantos Hearing Technology (Shanghai) Co., Ltd. The main drafters of this document are. Miao Jia, Fan Tingbo, Hu Jimin, Li Ning, Cui Jian, Zhang Shijun, and Xia Qingwei.

Introduction

Safety standards for medical electrical equipment, also known as the 9706 series standards, consist of general standards, parallel standards, special standards, guidelines, and interpretations. ---General Standards. Safety standards that are generally applicable to medical electrical equipment; that is, all equipment conforming to the definition of medical electrical equipment should meet these standards. Basic standard requirements. ---Parallel Standards. Safety standards that should be universally applicable to medical electrical equipment, but in most cases limited to those with certain specific functions or features. Only devices that are sensitive to sexual activity need to meet such standard requirements. ---Specific standards. Safety standards applicable to a certain class of medical electrical equipment; not all medical electrical equipment has specific standards. standard. ---Guidelines and Explanations. Application guidelines and explanations of the relevant requirements in the standards involved. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment - Part 1.General Requirements for Basic Safety and Basic Performance". beg". In this document, an asterisk (*) serves as the first character of a heading, the beginning of a paragraph, or the table heading, indicating that a related item is located in Appendix AA. Specialized guidelines and explanations of principles related to the project. Medical electrical equipment Parts 2-66.Hearing aids and related equipment Basic safety and basic performance requirements for hearing systems 201.1 Scope, Purpose and Relevant Standards Except as otherwise provided below, Chapter 1 of General Standard 1) applies. 201.1.1 *Scope replace. This document specifies the basic safety requirements for hearing aids and hearing aid systems. This document applies to hearing aids and hearing aid systems (hereinafter referred to as...). ME devices and ME systems). If a chapter or article explicitly states that it applies only to hearing aids or hearing aid systems, this will be stated in the title and the body of the chapter or article. Otherwise... In this case, the relevant chapter or article applies to both hearing aids and hearing aid systems. Except for.201.7.9.2 and.201.9.6, the dangers arising from the expected physiological effects of hearing aids or hearing aid systems within the scope of this document. (Source) is not specifically required in this document. Note 1.See section 4.2 of the general standard. In a home care environment, hearing aid accessories (such as remote controls, audio stream processors, battery chargers, and power supplies) can be configured according to applicable standards. Perform testing according to standards such as GB 4943.1 or other applicable safety standards. Alternatively, general standards may also apply. Hearing aids are not intended to provide communication. The power supply portion connected to the power grid. The hearing aid system is connected to the power grid via a power supply, charger, or other types of accessories. Accessories that are functionally connected to a hearing aid can form a hearing aid system. Hearing aids that are not physically connected to the hearing aid during normal use are... The accessories are not considered part of the application because they do not directly contribute to the intended use of the hearing aid. The wireless programming interface is covered by applicable standards. GB 4943.1 or other applicable security standards. Alternatively, general standards may apply. The programming interface for wired connections to hearing aids is covered by common standards. Note 2.Detachable parts of a hearing aid, even if supplied separately (such as ear hooks, earplugs, anti-cerumen devices, etc.), are considered components rather than accessories. This document is not applicable to. ---Cochlear implant devices or other implantable hearing aids; ---Bone conduction hearing aids; --- Hearing aids for educational purposes (such as hearing aid sets, auditory training devices, etc.); ---Hearing aids for measuring hearing level, conforming to GB/T 7341.1; ---Fixed-mount audio sensing loop systems or components thereof as described in GB/T 25102.4 and IEC 62489-1; ---The sound output function of the tinnitus masker. This document does not cover applicable tests for intentional radio frequency radiation from wireless devices (such as maximum radiated output power, modulation bandwidth, etc.). 201.1.2 Purpose replace. The purpose of this document is to establish the basic safety specifications for hearing aids and hearing aid systems as defined in.201.3.202 and.201.3.203. Require. 201.1.3 *Parallel Standards Supplement. 1) In this document, GB 9706.1-2020 is referred to as the general standard. ...