YY/T 0636.2-2021 Active Industry standards-Medicine

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

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

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0636.2-2021

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: 2022-04-01

Publisher: 国家药品监督管理局

Technical Committee: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)

Pages: 24 pages

Scope

YY/T 0636的本部分规定了用于咽部吸引的人工驱动吸引设备的安全和性能要求。
YY/T 0636的本部分适用于通过脚踏、手动或两者并用的设备。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。
人工驱动吸引设备通常是在医疗保健机构之外的情况下使用，常被描述为野外使用或运输使用。在这些情况下使用时可能涉及极端的天气或地形条件。YY/T 0636本部分中也包括用于野外和/或运输的吸引设备的附加要求。
YY/T 0636的本部分不适用于以下内容：
a)吸引导管、杨克式吸引管和吸引头等终端件；
b)牙科吸引设备；
c)黏液提取器，包括新生儿黏液提取器。

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

Drafting Persons:

郁红漪、李桂花、王伟、张燕凤、傅国庆、邵国樑

Word Count: 40 Thousand words Pages: 24 pages

Same series standard

YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source

Replace the following standards

YY 0636.2-2008 Medical suction equipment—Part 2:Manually powered suction equipment

Referenced Standards

ISO 80369(所有部分) EN 1041 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 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 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 10079-2:2014

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