This standard is the Chinese version electronic standard. After you successfully purchase, we will send the electronic version of this standard to your email address. If you have any question, please contact email: ChineseStandardsLibraryS001@gmail.com.
Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
Standard in brief
Scope of Application：
YY/T 1465的本部分规定了用流式细胞术测定动物脾脏淋巴细胞亚群的方法。本部分适用于评价医疗器械/材料诱导产生的免疫应答。
Basic information
Standard No：YY/T 1465.6-2019
Standard Name：医疗器械免疫原性评价方法 第6部分：用流式细胞术测定动物脾脏淋巴细胞亚群
English Name：Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
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：11.120.20
CCS Number：C30
Related Standards
Referenced Standards：GB/T 16886.1,GB/T 16886.2,GB/T 16886.12,GB/T 16886.20
Publication Information
Number of pages：12
Number of words：14 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：1465.6
Drafter：侯丽、孙晓霞、戴政宁、贺学英、王蕊
Drafting Organization：山东省医疗器械产品质量检验中心、北京市医疗器械检验所
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
