YY/T 0339-2019 Active Industry standards-Medicine

YY/T 0339-2019 Suction catheters for use in the respiratory tract

YY/T 0339-2019 Suction catheters for use in the respiratory tract

Publish Date: 2019-05-31 Implement Date: 2020-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0339-2019
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: 2019-05-31
Implement Date: 2020-06-01
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: 29 pages

Scope

本标准规定了由柔韧材料制成的,预期用于呼吸道的吸引导管的要求,包括开放式和封闭式的吸引导管。
本标准适用于尖端呈弯形的吸引导管(如Coudé导管),或者是带有抽吸收集器的吸引导管,此类吸引导管不认为是特殊吸引导管。
本标准不适用于预期与可燃性麻醉气体或药剂、激光或电外科设备一起使用的吸引导管。
注: 上呼吸道激光手术气道管理的指南文件参见ISO/TR 11991[6]。

Development Information

Drafting Units:

上海市医疗器械检测所、江苏省医疗器械检验所、广州维力医疗器械股份有限公司

Drafting Persons:

傅国庆、秦黎、黄开根、祝琰琤、陈涛

Word Count: 48 Thousand words Pages: 29 pages

Replace the following standards

Superseded by the following standards

Referenced Standards

ISO 5367:2014 ISO 11135 ISO 11137-1 ISO 14155 EN 556-1:2001 EN 1041 EN 15986 ASTM D3002:2007 ASTM F640 GB/T 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings GB/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary 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 GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes 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 0466.2-2015 Medical devices—Symbols to be used with medical device labels, labelling,and information to be supplied—Part 2:Symbol development,selection and validation YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY 0636.2-2008 Medical suction equipment—Part 2:Manually powered suction equipment YY/T 0636.2-2021 Medical suction equipment—Part 2:Manually powered suction equipment YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source 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 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

Adopt standards

ISO 8836:2014

Related Standards

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