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Plasmapheresis centrifuge apparatus for single use
Standard in brief
Scope of Application:
本标准规定了一次性使用离心式血浆分离器(以下简称分离器)的要求,以保证与所配套的离心式自动血浆采集机相适应。
本标准规定的分离器采集、贮存的血浆用于制备血液制品,不能用于临床输血。
Basic information
Standard No:YY/T 0326-2017
Standard Name:一次性使用离心式血浆分离器
English Name:Plasmapheresis centrifuge apparatus for single use
Standard Status:现行
Release Date:2017-05-02
Effective Date:2018-04-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.20
CCS Number:C31
Related Standards
Referenced Standards:GB/T 1962.1,GB/T 1962.2,GB/T 6682,GB 8369,GB 14232.1,GB/T 14233.1-2008,GB/T 16886.1,YY/T 0328,YY 0321.3-2009,YY/T 0615.1,YY/T 1288-2015,ISO 11607-1:2006
Publication Information
Number of pages:28
Number of words:46 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-11-01
Standard Revision Information
Has Amendment:No
Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0326
Drafter:杨勇、张庆、聂佳祺、刘忠让、鲁安松、张敏、翟庆斌、王建卫
Drafting Organization:四川南格尔生物医学股份有限公司、山东省医疗器械产品质量检验中心、陕西正源科技发展有限责任公司、重庆三大伟业制药有限公司、山东中保康医疗器具有限公司、成都市佳颖医用制品有限公司、山东威高集团医用高分子制品股份有限公司
Management Organization:全国医用输液器具标准化技术委员会(SAC/TC 106)