ISO 14730-2000 眼科光学接触镜保护产品抗菌防护效能试验和测定报废日期指南

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【英文标准名称】:Ophthalmicoptics-Contactlenscareproducts-Antimicrobialpreservativeefficacytestingandguidanceondeterminingdiscarddate
【原文标准名称】:眼科光学接触镜保护产品抗菌防护效能试验和测定报废日期指南
【标准号】:ISO14730-2000
【标准状态】:现行
【国别】:国际
【发布日期】:2000-09
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC172
【标准类型】:()
【标准水平】:()
【中文主题词】:说明书;眼科学;载荷试验;设置;保存;接触镜片;物理性能;使用寿命;防腐剂;清洗材料;试验规程;眼科光学;测定;光学;储存质量;定义;消耗量限制;应用;研究方法;试验;对视力的帮助;保存剂;抗微生物;效率;负荷
【英文主题词】:Aidtovision;Antimicrobial;Cleaningmaterials;Consumptionrestrictions;Contactlenses;Definitions;Determination;Efficiency;Establishment;Instructions;Loading;Loadingtests;Ophthalmicoptics;Ophthalmology;Optics;Physicalproperties;Preservation;Preservative;Preservativeagents;Preservatives;Researchmethods;Storagequality;Testprocedures;Testing;Usablelife;Use
【摘要】:ThisInternationalStandardspecifiesaproceduretobeusedinevaluatingtheantimicrobialpreservativeactivityofallpreservedmultidosecontactlenscareproducts,andprovidesguidanceonmethodstobeusedfordeterminationofdiscarddateasinformativeannexes.Thistestisapplicabletoproductsforuptoa28-daydiscarddate.Thetestisnotapplicabletosterileproductspackagedinunitdosesforsingleuseormultidosecontainersdesignedwithphysicalbarrierstomicrobialcontamination(e.g.aerosolcontainers).NOTE1Principlesofthetestmaybeusedtoextenddiscarddatingbeyond28days.SeeannexesB,C,DandE.NOTE2Useofmultipleormixedmicrobialchallengesand/orinclusionofcontactlensesorotherorganicloadcaninfluencetheapparentantimicrobialactivityofaparticularproduct.Theevaluationofthesevariablestogetherwithtestingagainstalargerpanelofmicroorganismsandtestingofsamplesfrompartiallyusedcontainersmaybeofvalueindevelopingacontactlenscareproduct,butareexcludedfromthescopeofthisInternationalStandard.
【中国标准分类号】:C32
【国际标准分类号】:11_040_70
【页数】:23P;A4
【正文语种】:英语