GB 11246-1989
Abolished
GB 9706.212-2020
Active
National standards
force_standard
GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators
GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators
Price:
$ 135
Basic Information
Standard Code:
GB 9706.212-2020
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Surgical room equipment
ICS Name:
Anesthesia, respiration, and resuscitation equipment
Publish Date:
2020-04-09
Implement Date:
2023-05-01
Pages:
68 pages
Scope
This part of GB 9706 specifies the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
If a chapter or an article explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or article will indicate this. If this is not the case, the relevant chapters or articles apply to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
In GB 9706.1-2020, 1.1 is replaced by the following content:
——This part applies to the basic safety and basic performance of ventilators used in combination with their accessories, hereinafter referred to as ME devices: intended for patients who rely on mechanical ventilation and are cared for by professional operators; and
Note 1: Such ventilators are considered as ME devices or ME systems for life support.
——Intended for use in emergency care environments in professional medical settings, or intended for use in transfers within professional medical settings.
Note 2: Intensive care ventilators used for transfers within professional medical settings are not considered as emergency and transfer ventilators.
The provisions of this part also apply to accessories that the manufacturer intends to connect to VBS or ventilators, and the characteristics of such accessories may affect the basic safety and basic performance of ventilators.
This part does not apply to ME devices and ME systems operating in ventilation modes used by patients who do not rely on mechanical ventilation.
Note 3: Intensive care operating in the aforementioned modes is not considered as ME devices or ME systems for life
Development Information
Same series standard
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment
GB 9706.201-2020 Medical electrical equipment—Part 2-1:Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
GB 9706.203-2020 Medical electrical equipment—Part 2-3:Particular requirements for the basic safety and essential performance of short-wave therapy equipment
GB 9706.205-2020 Medical electrical equipment—Part 2-5:Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
GB 9706.206-2020 Medical electrical equipment—Part 2-6:Particular requirements for the basic safety and essential performance of microwave therapy equipment
GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
GB 9706.217-2020 Medical electrical equipment—Part 2-17:Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
GB 9706.228-2020 Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
GB 9706.237-2020 Medical electrical equipment—Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
GB 9706.245-2020 Medical electrical equipment—Part 2-45:Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
GB 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
GB 9706.260-2020 Medical electrical equipment—Part 2-60:Particular requirements for the basic safety and essential performance of dental equipment
GB 9706.263-2020 Medical electrical equipment—Part 2-63:Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
Replace the following standards
Referenced Standards
YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY/T 0664-2008 Medical device software—Software life cycle processes
YY 0709-2009 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
ISO 2882
ISO 3864-1:2002
ISO 7000:2004
ISO 7010:2011
ISO 9614-1
ISO 80000-1:2009
IEC 60601-1-6
IEC 60730-1:2010
IEC 60851-3:2009
IEC 60851-5:2008
GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement
GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement
GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings
GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock
GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance
GB/T 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane
GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 31523.1-2015 Safety information identification systems—Part 1:Signs
GB 50751-2012 Technical code for medical gases engineering
YY 0339-2009 Suction catheter for use in the respiratory tract
YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators
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 0601-2007 Anaesthetic gas monitors
YY 0601-2009 The basic safety and main performance specific requirements for medical electrical equipment respiratory gas monitoring devices
YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements
YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment
YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source
YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source
YY/T 0735.1-2009 Anaesthetic and respiratory equipment—Heat and moisture exchangers(HMEs)for humidifying respired gases in humans—Part 1:HMEs for use with minimum tidal volumes of 250 mL
YY/T 0735.2-2010 Anaesthetic and respiratory equipment—Heat and moisture exchangers(HMEs) for humidifying respired gases in humans—Part 2:HMEs for use with tracheostomized patients having minimum tidal volumes of 250 mL
YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use—Part 1:Salt test method to assess filtration performance
YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use—Part 2:Non-filtration aspects
YY 0786-2010 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems
YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases
YY/T 0893-2013 Gas mixers for medical use—Stand-alone gas mixers
YY/T 0893-2023 Gas mixers for medical use—Standalone gas mixers
YY 0893-2013 Medical gas mixer/independent gas mixer
YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets
YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices
ISO 4871:1996
ISO 7396-1
ISO 10524-1:2006
ISO 14937
ISO 17664
ISO 80601-2-13:2015
IEC 60601-1-6:2010
IEC 60601-1-11
IEC 60601-2-2
IEC 61672-1:2002
Adopt standards
ISO 80601-2-12:2011
Related Standards
YY 0339-2002
Replaced
YY 0339-2002 Suction catheter for use in the respiratory tract
YY/T 0337.1-2002
Active
YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors
YY/T 0337.2-2002
Active
YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube
YY/T 0338.1-2002
Replaced
YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults
YY/T 0338.2-2002
Replaced