GB/T 4506-1984
Abolished
YY/T 0612-2022
Active
Industry standards-Medicine
YY/T 0612-2022 Single-use receptacles for human arterial blood specimen collection(arterial blood gas collection needles)
YY/T 0612-2022 Single-use receptacles for human arterial blood specimen collection(arterial blood gas collection needles)
Basic Information
Standard Code:
YY/T 0612-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2022-07-01
Implement Date:
2023-07-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
20 pages
Scope
本文件规定了血气分析用一次性使用人体动脉血样采集器(常称“动脉血气针”)的物理性能、生物性能、化学性能、添加剂等要求。
本文件适用于一次性使用人体动脉血样采集器,包括预设型血样采集器和抽血型血样采集器。
本文件不包括静脉血样采集容器和末梢血样采集容器的要求。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、碧迪医疗器械(上海)有限公司、山东新华安得医疗用品有限公司、雷度米特医疗设备(上海)有限公司、威海威高采血耗材有限公司、河南省驼人医疗科技有限公司
Drafting Persons:
姚秀军、张磊、孟凯、付健、黄羽倩、刘幸林、田靖、许晶、夏杰
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB 15810-2019 Sterile syringes for single use
GB 15811-2016 Sterile hypodermic needles for single use
ISO 23908
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 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
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
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced