GB 11246-1989
Abolished
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
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
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Superseded by the following standards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
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