GB 8369.1-2019 Active National standards force_standard

GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed

GB 8369.1-2019 Transfusion sets for single use—Part 1:Gravity feed

Publish Date: 2019-10-14 Implement Date: 2021-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 8369.1-2019
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: 2019-10-14
Implement Date: 2021-05-01
Publisher: 国家市场监督管理总局、中国国家标准化管理委员会
Technical Committee: 国家药品监督管理局
Pages: 22 pages

Scope

GB 8369的本部分规定了一次性使用、重力输血式医用输血器的材料、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器具配合使用的重力输血式输血器。

Development Information

Drafting Units:

山东省医疗器械产品质量检验中心、上海康德莱企业发展集团股份有限公司、山东威高集团医用高分子制品股份有限公司、江西洪达医疗器械集团有限公司、山东新华安得医疗用品有限公司、天津哈娜好医材有限公司、江西三鑫医疗科技股份有限公司

Drafting Persons:

贾彧飞、卢文博、高亦岑、王毅、王海银、孟凯、董超群、乔春霞、朱丽、刘炳荣

Word Count: 40 Thousand words Pages: 22 pages

Replace the following standards

Referenced Standards

GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods ISO 3826-1:2013 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 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 15811-2001 Sterile hypodermic needles for single use GB 15811-2016 Sterile hypodermic needles for single use 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 15811-2025 Sterile hypodermic needles 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 1135-4:2015

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