GB 8369.2-2020 Active National standards force_standard

GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use

GB 8369.2-2020 Transfusion sets for single use—Part 2:With pressure infusion apparatus use

Publish Date: 2020-11-17 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 8369.2-2020
Standard Type: National standards
Standard Status: Active
is_force_gb: yes
CCS Name: Generally, it refers to microsurgical instruments
ICS Name: Blood transfusion, infusion, and injection equipment
Publish Date: 2020-11-17
Implement Date: 2022-06-01
Publisher: 国家市场监督管理总局、国家标准化管理委员会
Technical Committee: 国家药品监督管理局
Pages: 25 pages

Scope

GB 8369的本部分规定了能产生200 kPa(2 bar)及以下压力的输血设备用的一次性使用输血器的材料、物理、化学和生物等要求。
本部分适用于一次性使用的、与血液及血液成分容器和静脉注射器具配合使用的压力输血设备用输血器。

Development Information

Word Count: 46 Thousand words Pages: 25 pages

Referenced Standards

GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB 14232.1-2020 Plastics collapsible containers for human blood and blood components—Part 1:Conventional containers GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods ISO 80369-7:2016 GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed GB/T 14232.2-2015 Plastics collapsible containers for human blood and blood components—Part 2:Graphical symbols for use on labels and instruction leaflets 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 GB/T 25915.1-2010 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness GB/T 25915.1-2021 Cleanrooms and associated controlled environments—Part 1:Classification of air cleanliness by particle concentration 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 1288-2015 Nylon blood filter nets for transfusion equipments for single use GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods

Adopt standards

ISO 1135-5:2015

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