YY/T 0636.1-2021 Active Industry standards-Medicine

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

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

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 0636.1-2021
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: 国家药品监督管理局
Technical Committee: 全国麻醉和呼吸设备标准化技术委员会(SAC/TC 116)
Pages: 31 pages

Scope

YY/T 0636的本部分规定了电动医用与手术吸引设备的安全和性能要求。
本部分适用于医院等医疗保健机构,患者家庭护理以及野外和转运的设备。

Development Information

Drafting Units:

上海宝佳医疗器械有限公司、上海市医疗器械检测所、上海健康医学院

Drafting Persons:

李桂花、郁红漪、胡兆燕、张燕凤、王伟、邵国樑、杨晓庆、傅国庆

Word Count: 60 Thousand words Pages: 31 pages

Same series standard

Replace the following standards

Referenced Standards

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment IEC/TR 60878 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 4208-1993 Degrees of protection provided by enclosure (IP code) GB/T 4208-2008 Degrees of protection provided by enclosure(IP code) GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) 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 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 10079-1:2015+AMD1:2018

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