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Chinese Standard: YY/T 1292.4-2017

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Test for reproductive and developmental toxicity of medical devices—Part 4:Two-generation reproductive toxicity test


Standard in brief
Scope of Application:  
YY/T 1292的本部分给出了医疗器械/材料两代生殖毒性试验方法。
本部分适用于医疗器械/材料两代生殖和发育毒性评价。

Basic information
Standard No:YY/T 1292.4-2017
Standard Name:医疗器械生殖和发育毒性试验 第4部分:两代生殖毒性试验
English Name:Test for reproductive and developmental toxicity of medical devices—Part 4:Two-generation reproductive toxicity test
Standard Status:现行
Release Date:2017-02-28
Effective Date:2018-01-01
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 16886.2,GB/T 16886.3,GB/T 16886.12

Publication Information
Number of pages:12
Number of words:18 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2017-10-01

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:1292.4
Drafter:乔春霞、朱福余、曹苹、徐炜区
Drafting Organization:山东省医疗器械产品质量检验中心、深圳市医疗器械检测中心
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:国家食品药品监督管理总局

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