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Ophthalmic optics—Contact lens care products—Part 4:Antimicrobial preservative efficacy testing and determining discard date
Standard in brief
Scope of Application:
YY 0719的本部分规定了用于评价所有多次量防腐接触镜护理产品的抗微生物防腐作用的操作程序,并且给出了用于测定抛弃日期的指南,参见资料性附录B、附录C、附录D和附录E。本部分可用于抛弃日期为28 d的产品。本部分不适用于一次性使用的一次量包装无菌产品或采用物理屏障抗微生物污染的多次量容器(如气溶胶容器)。
Basic information
Standard No:YY/T 0719.4-2009
Standard Name:眼科光学 接触镜护理产品 第4部分:抗微生物防腐有效性试验及测定抛弃日期指南
English Name:Ophthalmic optics—Contact lens care products—Part 4:Antimicrobial preservative efficacy testing and determining discard date
Standard Status:现行
Release Date:2009-06-16
Effective Date:2010-12-01
Language of Publication:中文简体
Standard Classification
ICS Number:11.040.70
CCS Number:C40
Related Standards
Referenced Standards:YY 0719.1,YY 0719.2
Adopted Standards:ISO 14730:2000
Adopted Standard Name:《眼科光学 接触镜护理产品 抗微生物防腐有效性试验及测定抛弃日期指南》
Adoption Level:IDT
Publication Information
Number of pages:24
Number of words:33 K
Format:大16
Edition:2
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2023-12-01
Standard Revision Information
Has Amendment:Yes
Amendment Note:有第1号修改单
Other Information
Application Dept:国家食品药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0719.4
Drafter:陈靖云、虞海蓉、李家忠、马莉、何涛、齐伟明
Drafting Organization:国家食品药品监督管理局杭州医疗器械质量监督检验中心
Management Organization:全国医用光学和仪器标准化分技术委员会(SAC TC 103/SC 1)
Proposing Department:全国医用光学和仪器标准化分技术委员会(SAC TC 103/SC 1)