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

Language

Chinese, Available in English version

Release Date

2020

Published By

国家市场监督管理总局、中国国家标准化管理委员会

Latest

GB 9706.1-2020

Replace

GB 9706.1-2007 GB 9706.15-2008

Scope

The scope of this standard is based on the definitions referenced to ME EQUIPMENT and ME SYSTEMS. This is to clearly define the scope of this standard and compare it with the requirements of other electrical equipment. [] Laboratory equipment within the scope of IEC 61010 122 is not within the scope of this standard, unless the manufacturer incorporates these laboratory equipment into the ME system. [] This section does not apply to active implantable medical devices specified in ISO 14708 131, unless ISO 14708 1 requires compliance with IEC 60601 1. This section does not apply to any other electrical equipment, unless it meets the definition of ME EQUIPMENT or ME SYSTEM. 152 GB9706.1—2020 Clause 1.3 Collateral Standards Collateral standards are formulated to extend common standards. Collateral standards include two categories: --- Involving additional basic safety and essential performance requirements, and usually subordinate to the requirements of ME equipment standards. For example, the general requirements provided by GB9706.12 are formulated to meet the ion radiation protection in medical diagnostic X-rays, so that patients, operators and other medical personnel are affected as little as possible; --- Involving additional basic safety and basic performance Requirements, standards specific to me equipment or me system characteristics and not covered by general standards. Until a new edition of such a collateral standard is published, users of this standard shall use the existing editions associated with me equipment and me systems. Of course, some requirements of these collateral standards may not be compatible with this section. The requirements of the two collateral standards developed for the second edition of IEC 60601 1 have been incorporated into this standard. The details are as follows; ——IEC60601 1 1:2000 Medical electrical equipment

GB 9706.1-2020 Referenced Document

• GB 18278.1 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes 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 3836.1 Explosive atmospheres.Part 1:Equipment.General requirements
• 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 7247.1-2012 Safety of laser products.Part 1:Equipment classification and requirements
• GB 8897.4 Primary batteries.Part 4:Safety of lithium batteries
• GB 8898-2011 Audio, video and similar electronic apparatus.Safety requirements
• GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• 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/T 1002 Single phase plugs and socket-outlets for household and similar purposes—Types，basic parameters and dimensions*， 2021-10-11 Update
• GB/T 1003 "Three phases plugs and socket outlets for household and similar purposes-Types,basic parameters and dimensions"
• GB/T 11021 Electrical insulation.Thermal evaluation and designation
• GB/T 11210 Rubber, vulcanized or thermoplastic-Antistatic and conductive products.Determination of electrical resistance
• GB/T 11918.1 Plugs, socket-outlet and couplers for industrial purposes.Part 1:General requirements
• 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 14790.1 Mechanical vibration.Measurement and evaluation of human exposure to hand-transmitted vibration.Part 1:General requirements
• GB/T 15092.1 Switches for appliances—Part 1:General requirements*， 2020-12-14 Update
• GB/T 16895.21 Low-voltage electrical installations—Part 4–41：Protection for safety—Protection against electric shock*， 2020-12-14 Update
• GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems.Part 1:Principles,requirements and tests
• GB/T 17465.1 Appliance couplers for household and similar general purposes—Part 1: General requirements*， 2022-07-11 Update
• GB/T 191 Packaging.Pictorial marking for handling of goods
• 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 2099.1 Plugs and socket-outlets for household and similar purposes—Part 1: General requirements*， 2021-10-11 Update
• GB/T 23821-2009 Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs
• GB/T 2423.2-2008 Environmental testing for electric and electronic products.Part 2:Test methods.Tests B:Dry heat
• GB/T 2439 Conducting and dissipative rubbers,vulcanized or thermoplastic--Measurement of resistivity
• 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 3667.1 Capacitors for AC motors - Part 1: General performance, testing and ratings Safety requirements Installation and operating guidelines
• 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 3785.1 Electroacoustics—Sound level meters—Part 1: Specifications*， 2023-05-23 Update
• GB/T 3785.2 Electroacoustics—Sound level meters—Part 2: Pattern evaluation tests*， 2023-05-23 Update
• GB/T 3836.5 Explosive atmospheres—Part 5：Equipment protection by pressurized enclosure “p”*， 2021-10-11 Update
• GB/T 3836.6 Explosive atmospheres—Part 6：Equipment protection by liquid immersion“o”
• GB/T 3836.7 Explosive atmospheres—Part 7: Equipment protection by powder filling “q”
• GB/T 4026 Basic and safety principles for man-machine interface, marking and identification—Identification of equipment terminals, conductor terminations and conductors
• GB/T 4205 Basic and safety principles for man-machine interface(MMI),marking and identification.Actuating principles
• GB/T 4207 Method for the determination of the proof and the comparative tracking indices of solid insulating materials*， 2022-07-11 Update
• GB/T 4208 Degrees of protection provide by enclosure (IP code)
• GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V.Part 1:General requirements
• 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 5465.2 Graphical symbols for electrical equipment Part 2: Graphical symbols*， 2023-12-28 Update
• 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/T 9364.1 Miniature fuses.Part 1:Definitions for miniature fuses and general requirement for miniature fuse-links
• IEC 60112:2009 Method for the determination of the proof and the comparative tracking indices of solid insulating materials*， 2024-04-20 Update
• IEC 60309-1:2012 Plugs, socket-outlets and couplers for industrial purposes - Part 1: General requirements
• IEC 60320-1:2007 Appliances couplers for household and similar general purposes - Part 1: General requirements
• IEC 60335-1:2004 Household and similar electrical appliances – Safety – Part 1: General requirements (Edition 4.1: Edition 4:2001 consolidated with amendment 1:2004)
• IEC 60364-4-41:2005 Low-voltage electrical installations - Part 4-41: Protection for safety - Protection against electric shock
• IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability*， 2024-04-20 Update
• IEC 60730-1:2010 Automatic electrical controls for household and similar use - 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
• ISO 2878:2011 Rubber, vulcanized or thermoplastic - Antistatic and conductive products - Determination of electrical resistance
• 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 9614-1 Acoustics; determination of sound power levels of noise sources using sound intensity; part 1: measurement at discrete points
• YY 0505 Medical electrical equipment.Part 1-2:General requirements for safety.Collateral standard:Electromagnetic compatibility.Requirements and tests
• 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/T 0316-2016 Medical devices.Application of risk management to medical devices
• YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
• YY/T 0664-2008 Medical devices software.Software life cycle processes

GB 9706.1-2020 history

• 2020 GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• 2007 GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
• 1995 GB 9706.1-1995 Medical electrical equipment--Part 1: General requirements for safety

GB 9706.1-2020 -All Parts