Detail of GB 9706.1-2020

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