2025-6-23 18.97.9.175
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Position: Chinese Standard in English/GB 9706.1-2020
GB 9706.1-2020   Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (English Version)
Standard No.: GB 9706.1-2020 Status:valid remind me the status change

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Language:English File Format:PDF
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Standard No.: GB 9706.1-2020
English Name: Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
Chinese Name: 医用电气设备 第1部分:基本安全和基本性能的通用要求
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: GB    National Standard
Issued by: SAMR; SAC
Issued on: 2020-04-09
Implemented on: 2023-5-1
Status: valid
Superseding:GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
Language: English
File Format: PDF
Word Count: 145000 words
Price(USD): 1700.0
Delivery: via email in 1 business day
GB 9706 Medical electrical equipment consists of 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: radiation protection in diagnostics 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 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrilllator ——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 1MV ——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 aesthetic 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 2-17: Particular requirements for the basic safety and essential performance of endoscopic equipment ——Part 2-19: Particular requirements for basic safety and essential performance of baby 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 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 medical diagnostic X-ray tube assemblies ——Part 2-29: Particular requirements for the basic safety and essential performance of adiotherapy 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 basic safety and essential performance 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 mammographic X-ray equipment and mammographic sterotactic devices ——Part 2-54: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment ——Part 2-60: Particular requirements for the basic safety and essential performance of essential performance of X-ray equipment for radiography and radioscopy ——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 2-65: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems This is Part 1 of GB 9706. Medical electrical equipment—Part 1: General requirements for basic safety and essential performance 1 Scope, object and related standards 1.1 *Scope This part of GB 9706 specifies the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. Note 1: See also 4.2. The 9706 series does not apply to: ——in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [69]; ——implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or ——medical gas pipeline systems covered by ISO 7396-1 [68]. Note 2: ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. Note 3: the asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines and principles related to the item in Annex A. 1.2 Object The object of this standard is to specify general requirements and to serve as the basis for particular standards. 1.3 * Collateral standards In the 9706 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to: ——a group of ME EQUIPMENT (e.g. radiological equipment); ——a specific characteristic of all ME EQUIPMENT not fully addressed in this standard. Applicable collateral standards become normative at the date of their publication and shall apply together with this standard. Note 1: When evaluating compliance with this standard, it is permissible to independently assess compliance with the collateral standards. Note 2: When declaring compliance with this standard, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation. If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard. 1.4 * Particular standards In the 9706 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over this standard. 2 Normative references The 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.   Attention: Additional collateral standards of the 9706 series, which are issued subsequent to publication of this standard, become normative at the date of their publication and shall be considered as being included among the normative references below. See 1.3. GB/T 191 Packaging—Pictorial marking for handling of goods (GB/T 191-2008, ISO 780: 1997, MOD) GB/T 1002 Single phase plugs and socket-outlets for household and similar purposes—Types, basic parameters and dimensions GB/T 1003 Three phase plugs and socket-outlets for household and similar purposes—Types, basic parameters and dimensions GB/T 2099.1 Plugs and socket-outlets for household and similar purposes—Part 1: General requirements (IEC 60884-1:2006, IDT) GB/T 2423.2-2008 Environmental testing—Part 2: Test methods—Tests B: Dry heat (IEC 60068-2-2: 2007, IDT) GB/T 2439 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity (GB/T 2439-2001, idt ISO 1853: 1998) GB/T 2941 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity (GB/T 2941-2006, ISO 23529: 2004, IDT) GB/T 3667.1 AC motor capacitors—Part 1: General—Performance, testing and rating—Safety requirements—Guide for installation and operation (GB/T 3667.1-2016, IEC 60252-1: 2013, IDT) GB/T 3768 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane (GB/T 3768-2017, ISO 3746:2010, IDT) GB/T 3785.1 Electroacoustics—Sound level meters—Part 1: Specifications (GB/T 3785.1-2010, IEC 61672-1: 2002, IDT) GB/T 3785.2 Electroacoustics—Sound level meters—Part 2: Pattern evaluation tests (GB/T 3785.2-2010, IEC 61672-2:2003, IDT) GB 3836.1 Explosive atmospheres—Part 1: Equipment—General requirements (GB 3836.1-2010, IEC 60079-0: 2007, MOD) GB/T 3836.5 Explosive atmospheres—Part 5: Equipment protection by pressurized enclosure p (GB/T 3836.5-2017, IEC 60079-2: 2007, MOD) GB/T 3836.6 Explosive atmospheres—Part 6: Equipment protection by liquid immersion “o” (GB/T 3836.6-2017, IEC 60079-6: 2015, MOD) GB/T 3836.7 Explosive atmospheres—Part 7: Equipment protection by powder filling “q” (GB/T 3836.7-2017, IEC 60079-5: 2015, MOD) GB/T 4026 Basic and safety principles for man-machine interface, marking and identification—Identification of equipment terminals, conductor terminations and conductors (GB/T 4026-2019, IEC 60445: 2017, IDT) GB/T 4074.6-2008 Winding wires—Test methods—Part 6: Thermal properties (IEC 60851-6: 1996, IDT) GB/T 4205 Basic and safety principles for man-machine interface (MMI),marking and identification—Actuating principles (GB/T 4205-2010, IEC 60447: 2004, IDT) GB/T 4207 Method for the determination of the proof and the comparative tracking indices of solid insulating materials (GB/T, 4207-2012, IEC 60112: 2009, IDT) GB/T 4208 Degrees of protection provided by enclosure (IP code) (GB/T 4208—2017, IEC 60529: 2013, IDT) GB 4706.1-2005 Household and similar electrical appliances-Safety-Part 1: General requirements [IEC 60335-1: 2004 (Ed4.1), IDT] GB 4943.1-2011 Information technology equipment—Safety—Part 1: General requirements (IEC 60950-1: 2005, MOD) GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V—Part 1: General requirements (IEC 60245-1: 2003, IDT) GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750V—Part 1: General requirements (IEC 60227-1: 2007, IDT) GB/T 5169.16 Fire hazard testing for electric and electronic products—Part 16: Test flames—50 W horizontal and vertical flame test methods (GB/T 5169.16-2017, IEC 60695-11-10: 2013, IDT) GB/T 5465.2 Graphical symbols for use on electrical equipment—Part 2: Graphical symbols (GB/T 5465.2—2008, IEC 60417: 2007, IDT) GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment—Part 14: Sectional specification—Fixed capacitors for electromagnetic interference suppression and connection to the supply mains (IEC 60384-14: 2005, IDT) GB 7247.1-2012 Safety of laser products—Part 1: Equipment classification and requirement (IEC 60825 1: 2007, IDT) GB 8897.4 Primary batteries—Part 4: Safety of lithium batteries (GB 8897.4-2008, IEC 60086-4: 2007, IDT) GB 8898-2011 Audio, video and similar electronic apparatus—Safety requirements (IEC 60065: 2005, MOD) GB/T 9364.1 Miniature fuses—Part 1: Definitions for miniature fuses and general requirement for miniature fuse-links (GB/T 9364.1—2015, IEC 60127-1: 2006, MOD) GB 9706.12 Medical electrical equipment-Part 1: General requirements for safety 3.collateral STANDARD: General requirements for radiation protection in diagnostic X-ray equipment (GB 9706.12-1997, idt IEC 60601-1-3: 1994) GB/T 11021 Electrical insulation—Thermal evaluation and designation (GB/T 11021-2014, IEC 60085: 2007, IDT) GB/T 11210 Rubber, vulcanized or thermoplastic—Antistatic and conductive products—Determination of electrical resistance (GB/T 11210-2014, ISO 2878: 2011, IDT) GB/T 11918.1 Rubber, vulcanized or thermoplastic—Antistatic and conductive products—Determination of electrical resistance (GB/T 11918.1-2014, IEC 60309-1: 2012, MOD) GB/T 11918.2 Plug, socket-outlets and couplers for industrial purposes—Part 2: Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories (GB/T 11918.2-2014, IEC 60309-2: 2012, MOD) GB/T 14790.1 Mechanical vibration—Measurement and evaluation of human exposure to hand-transmitted vibration—Part 1: General requirements (GB/T 14790.1-2009, ISO 5349-1: 2001, IDT) GB/T 15092.1 Switches for appliances—Part 1: General requirements (GB/T 15092.1—2010, IEC 61058-1: 2008, IDT) GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)] GB/T 16895.21 Low-voltage electrical installations—Part 4-41: Protection for safety—Protection against electric shock (GB/T 16895.21-2011, IEC 60364-4-41: 2005, IDT) GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems—Part 1: Principles requirements and tests (IEC 60664-1: 2007, IDT) GB/T 17465.1 Appliances couplers for household and similar general purposes—Part 1: General requirements (GB/T 17465.1-2009, IEC 60320-1: 2007, MOD) GB 18278.1 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665-1: 2006, IDT) GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1: 2007, IDT) GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1 :Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006, IDT) GB/T 19212.2 Safety of power transformers, power supplies, reactors and similar products—Part 2: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications (GB/T 19212.2-2012, IEC 61558-2-1: 2007, IDT) GB/T 23821-2009 Safety of machinery—Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857: 2008, IDT) GB 27701 Mechanical safety of cathode ray tubes (GB 27701-2011, IEC 61965: 2003, IDT) GB/T 28164 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable application (GB/T 28164—2011, IEC 62133: 2002, IDT) YY/T 0316-2016 Medical devices—Application of risk management to medical devices (ISO 14971: 2007, IDT) YY/T 0466.1 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1: 2012, IDT) YY 0505 Medical electrical equipment-Part 1-2:General requirements for safety-Collateral standards: Electromagnetic compatibility-Requirements and tests (YY 0505-2012, IEC 60601-1-2: 2004, IDT) YY/T 0664-2008 Medical device software—Software life cycle processes (IEC 62304: 2006, IDT) YY 0709 Medical electrical equipment—Part 1-8: General requirements for safety—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (YY 0709-2009, IEC 60601-1-8: 2003, IDT) ISO 2882 Rubber, vulcanized—Antistatic and conductive products for hospital use—Electrical resistance limits ISO 3864-1: 2002 Graphical symbols—Safety colours and safety signs—Part 1: Design principles for safety signs in workplaces and public areas ISO 7000: 2004 Graphical symbols for use on equipment Index and synopsis ISO 7010: 2011 Graphical symbols—Safety colours and safety signs—Registered safety signs ISO 9614-1 Determination of sound power levels of noise sources using sound intensity—Measurement at discrete points ISO 80000-1: 2009 Quantities and units—Part 1: General IEC 60601-1-6 Medical electrical equipment—Part 1-6: General requirements for safety—Collateral standard: Usability IEC 60730-1: 2010 Automatic electrical controls—Part 1: General requirements IEC 60851-3: 2009 Winding wires Test methods Part 3: Mechanical properties IEC 60851-5: 2008 Winding wires Test methods—Part 5: Electrical properties 3 * Terms and definitions For the purpose of this document, the following terms and definitions apply. Note 1: Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. Values of an alternating, direct or composite voltage or current unless stated otherwise. Note 2: The term “electrical equipment” is used to mean ME EQUIPMENT (see 3.63) or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM (see 3.64). Note 3: When the term "safety" is used in this document in boldface, it does not mean "safety" as defined in YY/T 0316-2016, but rather is used to mean "the state of being protected from or guarded against hurt or injury; freedom from danger”. 3.1
Foreword I 1 Scope, object and related standards 2 Normative references 3 * Terms and definitions 4 General requirements 5 * General requirements for testing ME EQUIPMENT 6 * Classification of ME EQUIPMENT and ME SYSTEMS 7 ME EQUIPMENT identification, marking and documents 8 * Protection against electrical HAZARDS from ME EQUIPMENT 9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 10 * Protection against unwanted and excessive radiation HAZARDS 11 Protection against excessive temperatures and other HAZARDS 12 * Accuracy of controls and instruments and protection against hazardous outputs 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 15 Construction of ME EQUIPMENT 16 * ME SYSTEMS 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Referred in GB 9706.1-2020:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB/T 1002-2021 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions
*GB/T 1003-2016 Three phases plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions
*GB/T 2099.1-2021 Plugs and socket-outlets for household and similar purposes—Part 1: General requirements
*GB/T 2423.2-2008 Environmental testing - Part 2: Test methods - Tests B: Dry heat
*GB/T 2439-2001 Conducting and dissipative rubbers,vulcanized or thermoplastic--Measurement of resistivity
*GB/T 2941-2006 Rubber - General procedures for preparing and conditioning test pieces for physical test methods
*GB/T 3667.1-2016 AC motor capacitors—Part 1:General—Performance,testing and rating—Safety requirements—Guide for installation and operation
*GB/T 3768-2017 Acoustics―Determination of sound power levels and sound energy levels ofnoise sources using sound pressure―Survey method using an envelopingmeasurement surface over a reflecting plane
*GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications
*GB/T 3785.2-2010 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests
*GB 3836.1-2010 Explosive atmospheres—Part 1:Equipment—General requirements
*GB/T 3836.5-2021 Explosive atmospheres—Part 5:Equipment protection by pressurized enclosure p
*GB/T 3836.6-2017 Explosive atmospheres―Part 6:Equipment protection by liquid immersion“o”
*GB/T 3836.7-2017 Explosive atmospheres―Part 7:Equipment protection by powder filling“q”
*GB/T 4026-2019 Basic and safety principles for man-machine interface, marking and identification—Identification of equipment terminals, conductor terminations and conductors
*GB/T 4074.6-2008/XG1-2012 Winding wires—Test methods—Part 6:Thermal properties
*GB/T 4205-2010 Basic and safety principles for man-machine interface(MMI),marking and identification—Actuating principles
*GB/T 4207-2022 Method for the determination of the proof and the comparative tracking indices of solid insulating materials
*GB/T 4208-2017 Degrees of protection provided by enclosure(IP code)
*GB 4706.1-2005 Household and Similar Electrical Appliances – Safety - Part 1: General Requirements
*GB 4943.1-2011 Information technology equipment -Safety - Part 1: General requirements
*GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V - Part 1:General requiremnts
*GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750V - Part 1: General requirements
*GB/T 5169.16-2017 Fire hazard testing for electric and electronic products―Part 16:Test flames―50 W horizontal and vertical flame test methods
*GB/T 5465.2-2008 Graphical Symbols for Use on Electrical Equipment - Part 2: Graphical Symbols
*GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment―Part 14:Sectional specification―Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
*GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements
*GB 8897.4-2008 Primary batteries - Part 4: Safety of lithium batteries
*GB 8898-2011 Audio,video and similar electronic apparatus—Safety requirements
*GB/T 9364.1-2015 Miniature fuses―Part 1:Definitions for miniature fuses and general requirement for miniature fuse-links
*GB 9706.12-1997 Medical electrical equipment-Part 1: General requirements for safety 3.collateral STANDARD: General requirements for radiation protection in diagnostic X-ray equipment
*GB/T 11021-2014 Electrical Insulation -Thermal Evaluation and Designation
*GB/T 11210-2014 Rubber,vulcanized or thermoplastic - Antistatic and conductive products - Determination of electrical resistance
*GB/T 11918.1-2014 Plugs,socket-outlet and couplers for industrial purposes―Part 1:General requirements
*GB/T 11918.2-2014 Plug, socket-outlets and couplers for industrial purposes―Part 2:Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories
*GB/T 14790.1-2009 vibration - Measurement and evaluation of human exposure to hand - Transmitted vibration - Part 1: General requirements
*GB/T 15092.1-2020 Switches for appliances—Part 1:General requirements
*GBT16886-
*(allparts)-
*GB/T 16895.21-2020 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock
*GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems - Part 1: Principles requirements and tests
*GB/T 17465.1-2022 Appliance couplers for household and similar general purposes—Part 1: General requirements
*GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
*GB 18279.1-2015 Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
*GB 18280.1-2015 Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
*GB/T 19212.2-2012 Safety of power transformers, power supplies, reactors and similar products―Part 2:Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications
*GB/T 23821-2009 Safety of machinery―Safety distances to prevent hazard zones being reached by upper and lower limbs
*GB 27701-2011 Mechanical safety of cathode ray tubes
*GB/T 28164-2011 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable application
*YY/T 0316-2016 Medical devices-Application of risk management to medical devices
*YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
*YY 0505-2012 Medical electrical equipment-Part 1-2:General requirements for safety-Collateral stanards:Electromagnetic compatibility-Requirements and tests
*YY/T 0664-2008 Medical device software - Software life cycle processes
*YY 0709-2009 cal electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
GB 9706.1-2020 is referred in:
*WS/T 648-2019 General hygienic requirement for air disinfecting machine?2019
*YY 0645-2018 Continuous blood purification equipment
*YY 0310-2005 General specifications for X-ray equipment for computed tomography
*YY 0793.2-2011 Technical requirements of water treatment equipments for haemodialysis applications and related therapies—Part 2:For single-bed haemodialysis
*GB 11239.1-2005 Operation microscopes Part1: Requirements and test methods
*YY/T 1738-2020 Energy consumption measurement methods for medical electrical equipment
*YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
*YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
*YY/T 1749-2020 External-vibration based ultrasonic elasticity measurement equipment for liver tissue
*GB 13955-2005 Installation and Operation of Residual Current Operated Protective Devices
*YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
*GB 15213-1994 Medical electron accelerators-Functional performance characteristics and test methods
*YY 0650-2022 General technical requirements for radio frequency ablation equipment
*YY 0054-2023 Haemodialysis equipment
*GJB 5309.32-2004 Test methods of initiating explosive devices 一Part 32: High frequency vibration test
*GB/T 22889-2021 Leather—Physical and mechanical tests—Determination of surface coating thickness
*GB/T 1551-2021 Test method for measuring resistivity of monocrystal silicon—In-line four-point probe and direct current two-point probe method
*GB/T 7735-2016/XG1-2021 Automated eddy current testing of seamless and welded (except submerged arc-welded) steel tubes for detection of imperfections, includes Amendment 1
*GB/T 39552.2-2020 Sunglasses and sunglare filters-Part 2:Test methods
*HJ 1014-2020 Emissions control technical requirements of non-road diesel mobile machinery
*GB/T 16895.21-2020 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock
*TSG 11-2020 Regulation on Safety Technology for Boiler
*GB 20075-2020 Passenger handholds and footrests on motorcycles
*GB 518-2020 Motorcycle tyres
*GJB 2919A-2015 Specification for germanium used in infrared optics
*GB/T 39514-2020 Terminology,defination,identification of biobased materials
*GB/T 39263-2020 Road vehicles—Advanced driver assistance systems—Terms and definitions
*GB/T 39172-2020 Non-steel wire rope suspension means for lifts
*GB/T 34370.11-2020 Nondestructive testing of amusement equipments—Part 11:Ultrasonic guided wave testing
*GB/T 4146.1-2020 Textiles—Man-made fibres—Part 1: Generic names
*GB/T 5620-2020 Road vehicles—Vocabulary and definition for braking of automotive vehicles and their trailers
*GB/T 29639-2020 Guidelines for enterprises to develop emergency response plan for work place accidents
*GB/T 39116-2020 Maturity model of intelligent manufacturing capability
*GB 16423-2020 Safety regulation for metal and nonmetal mines
*GB 146.1-2020 Gauge for standard gauge railways—Part 1: rolling stock gauge
*JT/T 475-2020 Trailer axle
*YD/T 3710-2020 Test methods of message layer of LTE-based vehicular communication
*YD/T 3709-2020 Technical requirements of message layer of LTE-based vehicular communication
*YD/T 3707-2020 Technical Requirements of Network Layer of LTE-based Vehicular Communication
*LY/T 1738-2020 Plywood for parquet
*GB 38850-2020 List for materials and restricted substances in disinfectant
*GB/T 5137.2-2020 Test methods of safety glazing materials used on road vehicles—Part 2:Optical properties tests
*GB/T 5137.1-2020 Test methods of safety glazing materials used on road vehicles—Part 1: Mechanical properties tests
*GB 38448-2019 Minimum allowable values and grades of the energy efficiency and water efficiency for smart water closets
*GB 28378-2019 Minimum allowable values of water efficiency and water efficiency grades for showers
*GB 25501-2019 Minimum allowable values of water efficiency and water efficiency grades for faucets
*GB 21455-2019 Minimum allowable values of the energy efficiency and energy efficiency grades for room air conditioners
*GB 2811-2019 Head protection—Safety helmets
*GB 2626-2019 Respiratory protection—Non-powered air-purifying particle respirator
*YY/T 1630-2018 Fundamental requirements for unique device identifier
*YY/T 0681.1-2018 Test methods for sterile medical device package―Part 1:Test guide for accelerated aging
*GB/T 24610.3-2019 Rolling bearings—Measuring methods for vibration—Part 3:Radial spherical and tapered roller bearings with cylindrical bore and outside surface
*GB/T 24610.2-2019 Rolling bearings—Measuring methods for vibration—Part 2:Radial ball bearings with cylindrical bore and outside surface
*GB/T 38146.1-2019 China automotive test cycle—Part 1:Light-duty vehicles
*GB 16737-2019 Road vehicle—World manufacturer identifier (WMI) code
*GB/T 38009-2019 Spectacle frames—Requirement and method for the detection of nickel release
*GB 24154-2015 National food safety standard — General standard for sports nutrition food
*GB 24154-2015/XG1-2021 National food safety standard - General rule for sports nutrition food (including Amendment 1)
*GB/T 24279.1-2018 Textiles-Determination of certain flame retardants-Part 1: Brominated flame retardants
*GB/T 2408-2008/XG1-2018 Plastics - Determination of burning characteristics - Horizontal and vertical test,includes Amnedment 1
*TSG D7002-2023 Pressure Piping Components Type Test Regulation
*GB 36894-2018 Risk criteria for hazardous chemicals production unit and storage installations
*GB/T 36664-2018 Ships and marine technology—Ship's mooring and towing fittings—Steel rollers
*GB 18078.1-2012 Health protection zone for agricultural and sideline food processing industry―Part 1:Slaughter,meat-processing industry
*TSG G0002-2010/XG1-2016 Supervision Administration Regulation on Energy Conservation Technology for Boiler,includes Amendment 1
*YY 0065-2016 Ophthalmic instruments - Slit-lamp microscopes
*YY/T 0758-2021 General requirements for medical laser fiber
*YY/T 0841-2023 Medical electrical equipment---Recurrent test and test after repair ofmedical electrical equipment
*YY/T 0740-2022 Particular specifications for medical X-ray angiography equipment
*YY/T 0742-2021 Particular specifications for gastrointestinal diagnostic X-ray equipment
*YY/T 1712-2021 Assisted surgical medical equipment and assisted surgical medical system employing robotictechnology
*YY 0599-2024 Laser therapeutic equipment - Excimer laser cornea ametropia equipment
*YY 0789-2024 Laser therapeutic equipment — Q-switched ophthalmic laser equipment
Code of China
Standard
GB 9706.1-2020  Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (English Version)
Standard No.GB 9706.1-2020
Statusvalid
LanguageEnglish
File FormatPDF
Word Count145000 words
Price(USD)1700.0
Implemented on2023-5-1
Deliveryvia email in 1 business day
Detail of GB 9706.1-2020
Standard No.
GB 9706.1-2020
English Name
Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
Chinese Name
医用电气设备 第1部分:基本安全和基本性能的通用要求
Chinese Classification
C30
Professional Classification
GB
ICS Classification
Issued by
SAMR; SAC
Issued on
2020-04-09
Implemented on
2023-5-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
Language
English
File Format
PDF
Word Count
145000 words
Price(USD)
1700.0
Keywords
GB 9706.1-2020, GB/T 9706.1-2020, GBT 9706.1-2020, GB9706.1-2020, GB 9706.1, GB9706.1, GB/T9706.1-2020, GB/T 9706.1, GB/T9706.1, GBT9706.1-2020, GBT 9706.1, GBT9706.1
Introduction of GB 9706.1-2020
GB 9706 Medical electrical equipment consists of 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: radiation protection in diagnostics 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 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrilllator ——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 1MV ——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 aesthetic 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 2-17: Particular requirements for the basic safety and essential performance of endoscopic equipment ——Part 2-19: Particular requirements for basic safety and essential performance of baby 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 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 medical diagnostic X-ray tube assemblies ——Part 2-29: Particular requirements for the basic safety and essential performance of adiotherapy 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 basic safety and essential performance 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 mammographic X-ray equipment and mammographic sterotactic devices ——Part 2-54: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment ——Part 2-60: Particular requirements for the basic safety and essential performance of essential performance of X-ray equipment for radiography and radioscopy ——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 2-65: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems This is Part 1 of GB 9706. Medical electrical equipment—Part 1: General requirements for basic safety and essential performance 1 Scope, object and related standards 1.1 *Scope This part of GB 9706 specifies the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS. This part applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1. Note 1: See also 4.2. The 9706 series does not apply to: ——in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [69]; ——implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or ——medical gas pipeline systems covered by ISO 7396-1 [68]. Note 2: ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS. Note 3: the asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines and principles related to the item in Annex A. 1.2 Object The object of this standard is to specify general requirements and to serve as the basis for particular standards. 1.3 * Collateral standards In the 9706 series, collateral standards specify general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE applicable to: ——a group of ME EQUIPMENT (e.g. radiological equipment); ——a specific characteristic of all ME EQUIPMENT not fully addressed in this standard. Applicable collateral standards become normative at the date of their publication and shall apply together with this standard. Note 1: When evaluating compliance with this standard, it is permissible to independently assess compliance with the collateral standards. Note 2: When declaring compliance with this standard, the declarer should specifically list the collateral standards that have been applied. This allows the reader of the declaration to understand which collateral standards were part of the evaluation. If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then the particular standard takes priority over the collateral standard. 1.4 * Particular standards In the 9706 series, particular standards may modify, replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over this standard. 2 Normative references The 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.   Attention: Additional collateral standards of the 9706 series, which are issued subsequent to publication of this standard, become normative at the date of their publication and shall be considered as being included among the normative references below. See 1.3. GB/T 191 Packaging—Pictorial marking for handling of goods (GB/T 191-2008, ISO 780: 1997, MOD) GB/T 1002 Single phase plugs and socket-outlets for household and similar purposes—Types, basic parameters and dimensions GB/T 1003 Three phase plugs and socket-outlets for household and similar purposes—Types, basic parameters and dimensions GB/T 2099.1 Plugs and socket-outlets for household and similar purposes—Part 1: General requirements (IEC 60884-1:2006, IDT) GB/T 2423.2-2008 Environmental testing—Part 2: Test methods—Tests B: Dry heat (IEC 60068-2-2: 2007, IDT) GB/T 2439 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity (GB/T 2439-2001, idt ISO 1853: 1998) GB/T 2941 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity (GB/T 2941-2006, ISO 23529: 2004, IDT) GB/T 3667.1 AC motor capacitors—Part 1: General—Performance, testing and rating—Safety requirements—Guide for installation and operation (GB/T 3667.1-2016, IEC 60252-1: 2013, IDT) GB/T 3768 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane (GB/T 3768-2017, ISO 3746:2010, IDT) GB/T 3785.1 Electroacoustics—Sound level meters—Part 1: Specifications (GB/T 3785.1-2010, IEC 61672-1: 2002, IDT) GB/T 3785.2 Electroacoustics—Sound level meters—Part 2: Pattern evaluation tests (GB/T 3785.2-2010, IEC 61672-2:2003, IDT) GB 3836.1 Explosive atmospheres—Part 1: Equipment—General requirements (GB 3836.1-2010, IEC 60079-0: 2007, MOD) GB/T 3836.5 Explosive atmospheres—Part 5: Equipment protection by pressurized enclosure p (GB/T 3836.5-2017, IEC 60079-2: 2007, MOD) GB/T 3836.6 Explosive atmospheres—Part 6: Equipment protection by liquid immersion “o” (GB/T 3836.6-2017, IEC 60079-6: 2015, MOD) GB/T 3836.7 Explosive atmospheres—Part 7: Equipment protection by powder filling “q” (GB/T 3836.7-2017, IEC 60079-5: 2015, MOD) GB/T 4026 Basic and safety principles for man-machine interface, marking and identification—Identification of equipment terminals, conductor terminations and conductors (GB/T 4026-2019, IEC 60445: 2017, IDT) GB/T 4074.6-2008 Winding wires—Test methods—Part 6: Thermal properties (IEC 60851-6: 1996, IDT) GB/T 4205 Basic and safety principles for man-machine interface (MMI),marking and identification—Actuating principles (GB/T 4205-2010, IEC 60447: 2004, IDT) GB/T 4207 Method for the determination of the proof and the comparative tracking indices of solid insulating materials (GB/T, 4207-2012, IEC 60112: 2009, IDT) GB/T 4208 Degrees of protection provided by enclosure (IP code) (GB/T 4208—2017, IEC 60529: 2013, IDT) GB 4706.1-2005 Household and similar electrical appliances-Safety-Part 1: General requirements [IEC 60335-1: 2004 (Ed4.1), IDT] GB 4943.1-2011 Information technology equipment—Safety—Part 1: General requirements (IEC 60950-1: 2005, MOD) GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V—Part 1: General requirements (IEC 60245-1: 2003, IDT) GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750V—Part 1: General requirements (IEC 60227-1: 2007, IDT) GB/T 5169.16 Fire hazard testing for electric and electronic products—Part 16: Test flames—50 W horizontal and vertical flame test methods (GB/T 5169.16-2017, IEC 60695-11-10: 2013, IDT) GB/T 5465.2 Graphical symbols for use on electrical equipment—Part 2: Graphical symbols (GB/T 5465.2—2008, IEC 60417: 2007, IDT) GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment—Part 14: Sectional specification—Fixed capacitors for electromagnetic interference suppression and connection to the supply mains (IEC 60384-14: 2005, IDT) GB 7247.1-2012 Safety of laser products—Part 1: Equipment classification and requirement (IEC 60825 1: 2007, IDT) GB 8897.4 Primary batteries—Part 4: Safety of lithium batteries (GB 8897.4-2008, IEC 60086-4: 2007, IDT) GB 8898-2011 Audio, video and similar electronic apparatus—Safety requirements (IEC 60065: 2005, MOD) GB/T 9364.1 Miniature fuses—Part 1: Definitions for miniature fuses and general requirement for miniature fuse-links (GB/T 9364.1—2015, IEC 60127-1: 2006, MOD) GB 9706.12 Medical electrical equipment-Part 1: General requirements for safety 3.collateral STANDARD: General requirements for radiation protection in diagnostic X-ray equipment (GB 9706.12-1997, idt IEC 60601-1-3: 1994) GB/T 11021 Electrical insulation—Thermal evaluation and designation (GB/T 11021-2014, IEC 60085: 2007, IDT) GB/T 11210 Rubber, vulcanized or thermoplastic—Antistatic and conductive products—Determination of electrical resistance (GB/T 11210-2014, ISO 2878: 2011, IDT) GB/T 11918.1 Rubber, vulcanized or thermoplastic—Antistatic and conductive products—Determination of electrical resistance (GB/T 11918.1-2014, IEC 60309-1: 2012, MOD) GB/T 11918.2 Plug, socket-outlets and couplers for industrial purposes—Part 2: Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories (GB/T 11918.2-2014, IEC 60309-2: 2012, MOD) GB/T 14790.1 Mechanical vibration—Measurement and evaluation of human exposure to hand-transmitted vibration—Part 1: General requirements (GB/T 14790.1-2009, ISO 5349-1: 2001, IDT) GB/T 15092.1 Switches for appliances—Part 1: General requirements (GB/T 15092.1—2010, IEC 61058-1: 2008, IDT) GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)] GB/T 16895.21 Low-voltage electrical installations—Part 4-41: Protection for safety—Protection against electric shock (GB/T 16895.21-2011, IEC 60364-4-41: 2005, IDT) GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems—Part 1: Principles requirements and tests (IEC 60664-1: 2007, IDT) GB/T 17465.1 Appliances couplers for household and similar general purposes—Part 1: General requirements (GB/T 17465.1-2009, IEC 60320-1: 2007, MOD) GB 18278.1 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665-1: 2006, IDT) GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1: 2007, IDT) GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1 :Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006, IDT) GB/T 19212.2 Safety of power transformers, power supplies, reactors and similar products—Part 2: Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications (GB/T 19212.2-2012, IEC 61558-2-1: 2007, IDT) GB/T 23821-2009 Safety of machinery—Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857: 2008, IDT) GB 27701 Mechanical safety of cathode ray tubes (GB 27701-2011, IEC 61965: 2003, IDT) GB/T 28164 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable application (GB/T 28164—2011, IEC 62133: 2002, IDT) YY/T 0316-2016 Medical devices—Application of risk management to medical devices (ISO 14971: 2007, IDT) YY/T 0466.1 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements (YY/T 0466.1-2016, ISO 15223-1: 2012, IDT) YY 0505 Medical electrical equipment-Part 1-2:General requirements for safety-Collateral standards: Electromagnetic compatibility-Requirements and tests (YY 0505-2012, IEC 60601-1-2: 2004, IDT) YY/T 0664-2008 Medical device software—Software life cycle processes (IEC 62304: 2006, IDT) YY 0709 Medical electrical equipment—Part 1-8: General requirements for safety—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (YY 0709-2009, IEC 60601-1-8: 2003, IDT) ISO 2882 Rubber, vulcanized—Antistatic and conductive products for hospital use—Electrical resistance limits ISO 3864-1: 2002 Graphical symbols—Safety colours and safety signs—Part 1: Design principles for safety signs in workplaces and public areas ISO 7000: 2004 Graphical symbols for use on equipment Index and synopsis ISO 7010: 2011 Graphical symbols—Safety colours and safety signs—Registered safety signs ISO 9614-1 Determination of sound power levels of noise sources using sound intensity—Measurement at discrete points ISO 80000-1: 2009 Quantities and units—Part 1: General IEC 60601-1-6 Medical electrical equipment—Part 1-6: General requirements for safety—Collateral standard: Usability IEC 60730-1: 2010 Automatic electrical controls—Part 1: General requirements IEC 60851-3: 2009 Winding wires Test methods Part 3: Mechanical properties IEC 60851-5: 2008 Winding wires Test methods—Part 5: Electrical properties 3 * Terms and definitions For the purpose of this document, the following terms and definitions apply. Note 1: Where the terms “voltage” and “current” are used in this document, they mean the r.m.s. Values of an alternating, direct or composite voltage or current unless stated otherwise. Note 2: The term “electrical equipment” is used to mean ME EQUIPMENT (see 3.63) or other electrical equipment. This standard also uses the term “equipment” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM (see 3.64). Note 3: When the term "safety" is used in this document in boldface, it does not mean "safety" as defined in YY/T 0316-2016, but rather is used to mean "the state of being protected from or guarded against hurt or injury; freedom from danger”. 3.1
Contents of GB 9706.1-2020
Foreword I 1 Scope, object and related standards 2 Normative references 3 * Terms and definitions 4 General requirements 5 * General requirements for testing ME EQUIPMENT 6 * Classification of ME EQUIPMENT and ME SYSTEMS 7 ME EQUIPMENT identification, marking and documents 8 * Protection against electrical HAZARDS from ME EQUIPMENT 9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 10 * Protection against unwanted and excessive radiation HAZARDS 11 Protection against excessive temperatures and other HAZARDS 12 * Accuracy of controls and instruments and protection against hazardous outputs 13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 15 Construction of ME EQUIPMENT 16 * ME SYSTEMS 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
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Keywords:
GB 9706.1-2020, GB/T 9706.1-2020, GBT 9706.1-2020, GB9706.1-2020, GB 9706.1, GB9706.1, GB/T9706.1-2020, GB/T 9706.1, GB/T9706.1, GBT9706.1-2020, GBT 9706.1, GBT9706.1