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

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

Publisher: 国家药品监督管理总局

Technical Committee: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC116)

Pages: 32 pages

Scope

YY/T 0636的本部分规定了由真空或正压源（文丘里吸引）驱动医用吸引设备的安全和性能要求，包括用于野外和/或转运的吸引设备的附加要求。
本部分适用于连接至医用气体管道系统或气瓶和文丘里附件的设备，该设备可以是独立设备，也可以是集成系统的一部分。
注：附录A通过提供典型系统的示意图说明了YY/T 0636的三个部分。
本部分不适用于：
a）中央动力系统（通过负压/压缩空气产生）、车辆和建筑物的管道系统以及墙壁连接器；
b）吸引导管、杨克式吸引管和吸引头等终端件；
c）注射器；
d）牙科吸引设备；
e）麻醉气体净化系统；
f）实验室吸引设备；
g）自体输液系统；
h）用于伤口引流的封闭系统；
i）黏液提取器，包括新生儿黏液提取器；
j）吸杯设备（产科用）；
k）吸乳器；
l）脂肪抽吸设备；
m）子宫吸引设备；
n）羽流疏散系统。

Development Information

Drafting Units:

上海市医疗器械检测所、上海宝佳医疗器械有限公司、捷锐企业(上海)有限公司

Drafting Persons:

王伟、李桂花、胡跃钢、郁红漪、张燕凤、祝琰琤、邵国樑、傅国庆

Word Count: 56 Thousand words Pages: 32 pages

Same series standard

YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY/T 0636.2-2021 Medical suction equipment—Part 2:Manually powered suction equipment

Replace the following standards

YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source

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

GB 11246-1989 Abolished

GB 11246-1989 Specifications for continuous flow inhalational anaesthetic machines for use with humans

Publish Date: 1989-03-31

YY 0339-2002 Replaced

YY 0339-2002 Suction catheter for use in the respiratory tract

Publish Date: 2002-09-24

YY/T 0337.1-2002 Active

YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors

Publish Date: 2002-09-24

YY/T 0337.2-2002 Active

YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube

Publish Date: 2002-09-24

YY/T 0338.1-2002 Replaced

YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults

Publish Date: 2002-09-24

YY/T 0338.2-2002 Replaced

YY/T 0338.2-2002 Tracheostomy tubes—Part 2:Paediatric tracheostomy tubes

Publish Date: 2002-09-24