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Pyrogen test for medical devices—Monocyte-activation test—Human whole blood ELISA method
Standard in brief
Scope of Application：
本标准给出了用人全血ELISA法测定医疗器械/材料中致热原的试验方法。
Basic information
Standard No：YY/T 1500-2016
Standard Name：医疗器械热原试验 单核细胞激活试验 人全血ELISA法
English Name：Pyrogen test for medical devices—Monocyte-activation test—Human whole blood ELISA method
Standard Status：现行
Release Date：2016-07-29
Effective Date：2017-06-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.120.20
CCS Number：C30
Related Standards
Referenced Standards：GB/T 16886.12
Publication Information
Number of pages：12
Number of words：16 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2017-04-01
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：1500
Drafter：范春光、王红、孙立魁、刘嘉馨、何红兵、吴旭君
Drafting Organization：山东恒信检测技术开发中心、中国医学科学院输血研究所、上海松力生物技术有限公司
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：国家食品药品监督管理总局
