YY/T 0929.3-2023 Active Industry standards-Medicine

YY/T 0929.3-2023 Liquid filters for medical infusion equipment—Part 3:Test method for determining liquid bacterial retention of 0.22 μm filter

YY/T 0929.3-2023 Liquid filters for medical infusion equipment—Part 3:Test method for determining liquid bacterial retention of 0.22 μm filter

Publish Date: 2023-11-22 Implement Date: 2024-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0929.3-2023
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: 2023-11-22
Implement Date: 2024-12-01
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: 13 pages

Scope

本文件描述了标称孔径0.22 μm输液用药液过滤器液体细菌截留能力的试验方法。本文件适用于标称孔径0.22 μm输液用药液过滤器液体细菌截留能力的评价,输液用药液过滤膜材液体细菌截留能力的评价可参考本文件。本文件不适用于0.22 μm输液用药液过滤器对特定种类药品细菌截留能力的验证。该验证宜采用特定药液或替代溶液在模拟实际临床输液条件下进行。

Development Information

Drafting Units:

山东省医疗器械和药品包装检验研究院、杭州安诺过滤器材有限公司、山东中保康医疗器具有限公司、武汉智迅创源科技发展股份有限公司、费森尤斯卡比(中国)投资有限公司

Drafting Persons:

王文庆、国宪虎、周一青、许俊峰、吴其玉、洪梅、方良艳

Word Count: 27 Thousand words Pages: 13 pages

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