GB/T 4506-1984
Abolished
YY 0329-2024
Pending
Industry standards-Medicine
YY 0329-2024 Leukocyte reduction filters for single use
YY 0329-2024 Leukocyte reduction filters for single use
Basic Information
Standard Code:
YY 0329-2024
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2024-07-08
Implement Date:
2027-07-20
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:
28 pages
Scope
本文件规定了一次性使用去白细胞滤器的分类与命名、材料、要求、标志和包装,描述了相应的试验方法。
本文件适用于一次性使用去白细胞滤器(以下简称“去白细胞滤器”)。
注:去白细胞滤器可与输血器、采血/血液成分分离系统连接,用于去除血液及血液成分中的白细胞。
Development Information
Replace the following standards
Referenced Standards
GB/T 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
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 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed
GB/T 14233.2-1993 Infusion, transfusion, injction equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2005 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological 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 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 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
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