YY/T 1743-2021 Active Industry standards-Medicine

YY/T 1743-2021 Anaesthetic and respiratory equipment—Nebulizing systems and components

YY/T 1743-2021 Anaesthetic and respiratory equipment—Nebulizing systems and components

Publish Date: 2021-03-09 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1743-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Surgical room equipment
ICS Name: Anesthesia, respiration, and resuscitation equipment
Publish Date: 2021-03-09
Implement Date: 2023-05-01
Pages: 48 pages

Scope

This standard specifies the requirements for safety and performance testing of general atomization systems that are intended to deliver liquids to the human body continuously or upon respiratory triggering in the form of a spray through the respiratory system.
This standard applies to pneumatic atomization devices, which can be powered by compressors, piping systems, cylinders, etc., as well as electric atomization devices [such as rotating discs, ultrasound, vibrating screens (active and passive), and capillary devices] or manual atomization devices.
This standard does not specify the minimum performance of atomization systems.
This standard does not apply to nasal irrigation devices.
This standard does not apply to devices intended solely for providing humidity or hydration by supplying water in the form of aerosol particles.
Note: Such devices are referred to in ISO 8185 [3].
This standard does not apply to specific drug delivery atomization devices or their components (such as metered dose inhalers, metered liquid inhalers, and dry powder inhalers).

Development Information

Word Count: 89 Thousand words Pages: 48 pages

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance YY/T 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 7396-1 ISO 10524-1 ISO 10524-3 EN 13544-2 ENV 737-6 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process 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 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators YY/T 0466.1-2009 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 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use—Part 1:Salt test method to assess filtration performance YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases YY/T 0801.1-2010 Terminal units for medical gas pipeline systems—Part 1:Terminal units for use with compressed medical gases and vacuum YY/T 0882-2013 Anaesthetic and respiratory equipment—Compatibility with oxygen 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 1040.2-2008 Anaesthetic and respiratory equipment—Conical connectors—Part 2:Screw-threaded weight-bearing connectors YY/T 1474-2016 Medical devices—Application of usability engineering to medical 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 YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis GB 50751-2012 Technical code for medical gases engineering GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control

Adopt standards

ISO 27427:2013

Related Standards

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