ISO 15798-2010 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】:ISO15798-2010
【标准状态】:现行
【国别】:国际
【发布日期】:2010-01
【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】:临床调查;结构细节;制造日期;定义;制造商提供的信息;处理;眼科设备;眼科光学;眼科学;光学;包装件;安全;安全要求;规范(验收);灭菌;外科学;外科植入物;粘弹性;弹粘性物质;粘度等级
【英文主题词】:Biocompatibility;Biological;Clinicalinvestigations;Constructiondetails;Dataofthemanufacturer;Definitions;Informationsuppliedbythemanufacturer;Marking;Medicaldevices;Ophthalmicequipment;Ophthalmicoptics;Ophthalmology;Optics;Packages;Safety;Safetyrequirements;Specification(approval);Sterilization(hygiene);Surgery;Surgicalimplants;Viscoelastic;Viscoelasticmaterials;Viscosityclasses
【摘要】:ThisInternationalStandardisapplicabletoophthalmicviscosurgicaldevices(OVDs),aclassofnon-activesurgicalimplantswithviscousand/orviscoelasticproperties,intendedforuseduringsurgeryintheanteriorsegmentofthehumaneye.OVDsaredesignedtocreateandmaintainspace,toprotectintra-oculartissuesandtomanipulatetissuesduringsurgery.ThisInternationalStandardspecifiesrequirementswithregardtosafetyfortheintendedperformance,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】:22P.;A4
【正文语种】:英语