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Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods
Standard in brief
Scope of Application:
本文件描述了医用输液、输血、注射器具无菌检查、细菌内毒素检查、生物负载测定和无菌试验方法。
本文件适用于医用输液、输血、注射器具。
Basic information
Standard No:GB/T 14233.3-2024
Standard Name:医用输液、输血、注射器具检验方法 第3部分:微生物学试验方法
English Name:Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological test methods
Standard Status:即将实施
Release Date:2024-10-26
Effective Date:2026-11-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.20
CCS Number:C31
Related Standards
Referenced Standards:GB/T 19973.1
Publication Information
Number of pages:20
Number of words:28 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2024-10-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家市场监督管理总局、国家标准化管理委员会
Standard Type:CN
Standard Attribute:GB
Other Standard Number:14233.3
Drafter:栾园园、王文庆、龙经、秦杰、李凌梅、龚耀仁、刘炳荣、杨婷茹、崔景强、巩向阳、张萌萌、孙令骁、李翠、马恒、房爱华
Drafting Organization:山东省医疗器械和药品包装检验研究院、山东威高集团医用高分子制品股份有限公司、强生(苏州)医疗器材有限公司、苏州百特医疗用品有限公司、美敦力(上海)管理有限公司、江西三鑫医疗科技股份有限公司、乐普(北京)医疗器械股份有限公司、河南驼人医疗器械集团有限公司、山东中保康医疗器具有限公司
Management Organization:全国医用输液器具标准化技术委员会(SAC/TC 106)
Proposing Department:国家药品监督管理局