ISO 15798-2001 眼科植入物眼科手术粘接器件

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【英文标准名称】:Ophthalmicimplants-Ophthalmicviscosurgicaldevices
【原文标准名称】:眼科植入物眼科手术粘接器件
【标准号】:ISO15798-2001
【标准状态】:现行
【国别】:国际
【发布日期】:2001-06
【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】:眼科设备;外科学;眼科光学;外科植入物;临床调查;黏弹性体;黏弹性体材料;光学;作标记;定义;定义;制造日期;规范(验收);安全
【英文主题词】:Clinicalinvestigations;Constructiondetails;Dataofthemanufacturer;Definition;Definitions;Marking;Ophthalmicequipment;Ophthalmicoptics;Ophthalmology;Optics;Packages;Safety;Specification(approval);Sterilization(hygiene);Surgery;Surgicalimplants;Viscoelastic;Viscoelasticmaterials;Viscosityclasses
【摘要】:ThisInternationalStandardappliestoophthalmicviscosurgicaldevices(OVDs),aclassofnon-activesurgicalimplantswithviscousand/orviscoelasticproperties,intendedforuseduringsurgeryintheanteriorsegmentofthehumaneye.OVDsaredesignedtocreateandmaintainspace,toprotectintra-oculartissuesandtomanipulatetissuesduringsurgery.OVDsarenotdesignedtohaveanypharmacologicaleffect.ThisInternationalStandarddefinesrequirementswithregardtosafetyfortheintendedperformance,designattributes,preclinicalandclinicalevaluation,sterilization,productpackaging,productlabellingandinformationsuppliedbythemanufacturerofthesedevices.
【中国标准分类号】:C32
【国际标准分类号】:11_040_70
【页数】:20P;A4
【正文语种】:英语