BS EN ISO 15798-2001 眼科植入物.黏弹性眼科植入装置

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【英文标准名称】:Ophthalmicimplants-Ophthalmicviscosurgicaldevices
【原文标准名称】:眼科植入物.黏弹性眼科植入装置
【标准号】:BSENISO15798-2001
【标准状态】:作废
【国别】:英国
【发布日期】:2001-07-15
【实施或试行日期】:2001-08-15
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:眼;外科设备;包装;眼科设备;眼科学;使用说明;外科植入物;安全措施;设计;医疗设备;性能;灭菌
【英文主题词】:Clinicalinvestigations;Constructiondetails;Dataofthemanufacturer;Definitions;Implants(surgical);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】:30P.;A4
【正文语种】:英语