GB 11246-1989
Abolished
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
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
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
Related Standards
YY 0339-2002
Replaced
YY 0339-2002 Suction catheter for use in the respiratory tract
YY/T 0337.1-2002
Active
YY/T 0337.1-2002 Tracheal tubes Part 1:—Commonly-used tubes and connectors
YY/T 0337.2-2002
Active
YY/T 0337.2-2002 Tracheal tubes—Part 2:Cole type tube
YY/T 0338.1-2002
Replaced
YY/T 0338.1-2002 Tracheostomy tubes—Part 1:Tubes and connectors for adults
YY/T 0338.2-2002
Replaced