Chinese Standard: YY/T 0878.3-2019

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Test for complement activation of medical devices—Part 3：Assay for the product of complement activation (C3a and SC5b-9)

Standard in brief
Scope of Application：  
YY/T 0878的本部分规定了用酶联免疫法测定血液中补体激活产物（C3a和SC5b9)的方法。本部分适用于体外对医疗器械/材料补体激活潜能的评价。本部分建立的试验体系适用于人血清或抗凝血浆。若使用动物血液，经论证其适宜性后进行试验。

Basic information
Standard No：YY/T 0878.3-2019
Standard Name：医疗器械补体激活试验　第3部分：补体激活产物(C3a和SC5b-9)的测定
English Name：Test for complement activation of medical devices—Part 3：Assay for the product of complement activation (C3a and SC5b-9)
Standard Status：现行
Release Date：2019-07-24
Effective Date：2020-08-01
Language of Publication：中文简体

Standard Classification
ICS Number：11.040.01
CCS Number：C30

Related Standards
Referenced Standards：GB/T 16886.1,GB/T 16886.4,GB/T 16886.12

Publication Information
Number of pages：12
Number of words：12 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2019-08-01

Standard Revision Information
Has Amendment：No

Other Information
Application Dept：国家药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0878.3
Drafter：刘成虎、范春光、梁洁、袁暾、李秋
Drafting Organization：山东省医疗器械产品质量检验中心、四川大学(四川医疗器械生物材料和制品检验中心)
Management Organization：全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Proposing Department：国家药品监督管理局