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Ophthalmic optics—Contact lenses and contact lenses care products—Determination of biocompatibility by ocular study with rabbit eyes
Standard in brief
Scope of Application：
本文件描述了评价接触镜和接触镜护理产品眼内安全性的体内试验方法。本试验是评价产品在试验条件下对眼组织产生刺激的程度。本文件适用于兔眼试验。
Basic information
Standard No：GB/T 28538-2023
Standard Name：眼科光学 接触镜和接触镜护理产品 兔眼相容性研究试验
English Name：Ophthalmic optics—Contact lenses and contact lenses care products—Determination of biocompatibility by ocular study with rabbit eyes
Standard Status：现行
Release Date：2012-06-29
Effective Date：2024-10-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.70
CCS Number：C40
Related Standards
Referenced Standards：GB/T 11417.1,GB/T 16886.1,GB/T 16886.2,GB/T 16886.10,GB/T 27025
Adopted Standards：ISO 9394:2012
Adopted Standard Name：《眼科光学 接触镜和接触镜护理产品 兔眼相容性研究试验》
Adoption Level：MOD
Publication Information
Number of pages：16
Number of words：29 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2023-09-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家市场监督管理总局、国家标准化管理委员会
Standard Type：CN
Standard Attribute：GB
Other Standard Number：28538
Drafter：陈献花、方丽、奚晓青、李婧、周森婷、周绮梦
Drafting Organization：浙江省医疗器械检验研究院
Management Organization：国家药品监督管理局
Proposing Department：国家药品监督管理局
