YY/T 0636.3-2021 Active Industry standards-Medicine

YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source

YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source

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
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Basic Information

Standard Code: YY/T 0636.3-2021
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: 32 pages

Scope

This part of YY/T 0636 specifies the safety and performance requirements for medical suction equipment driven by vacuum or positive pressure sources (Venturi suction), including additional requirements for suction equipment used in the field and/or during transport.
This part applies to equipment connected to medical gas piping systems or gas cylinders and Venturi accessories. The equipment may be standalone or part of an integrated system.
Note: Appendix A illustrates the three parts of YY/T 0636 by providing schematic diagrams of typical systems.
This part does not apply to:
a) Central power systems (generated by negative pressure/compressed air), vehicle and building piping systems, and wall connectors;
b) End-pieces such as suction catheters, Yankauer suction tubes, and suction heads;
c) Syringes;
d) Dental suction equipment;
e) Anesthetic gas purification systems;
f) Laboratory suction equipment;
g) Autologous transfusion systems;
h) Closed systems for wound drainage;
i) Mucus extractors, including neonatal mucus extractors;
j) Suction cup devices (for obstetrics);
k) Breast pumps;
l) Liposuction equipment;
m) Uterine suction devices;
n) Plume dispersion systems.

Development Information

Word Count: 56 Thousand words Pages: 32 pages

Same series standard

Replace the following standards

Referenced Standards

ISO 80369(所有部分) EN 1041 GB/T 3767-1996 Acoustics—Determination of sound power levels of noise sources using sound pressure—Engineering method in an essentially free field over a reflecting plane 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 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 16273.1-1996 Graphical symbols for use on equipment—Common symbols GB/T 16273.1-2008 Graphical symbols for use on equipment—Part 1:Common symbols YY/T 0297-1997 Clinical investigation of medical devices 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 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 0799-2010 Low-pressure hose assemblies for use with medical gases 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 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 YY/T 0297-2026 General requirements for clinical investigation of medical devices

Adopt standards

ISO 10079-3:2014

Related Standards

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