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

Publish Date: 2024-07-08 Implement Date: 2027-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 32 Thousand words Pages: 28 pages

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

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