【英文标准名称】:Externallimbprosthesesandexternalorthoses-Requirementsandtestmethods
【原文标准名称】:外置假肢和外部器械矫形.要求和试验方法
【标准号】:ISO22523-2006
【标准状态】:现行
【国别】:国际
【发布日期】:2006-10
【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/TC168
【标准类型】:()
【标准水平】:()
【中文主题词】:残疾人辅助器具;人造假肢;定义;设计;电气安全;人类工效学;精密机械;使用说明书;肢;载荷试验;材料;材料规范;矫形外科学;器械矫形装置;修复装置;规范(验收);材料强度;专门装备;试验
【英文主题词】:Aidsforthedisabled;Artificiallimbs;Definitions;Design;Electricalsafety;EMC;Ergonomics;Finemechanics;Informationsuppliedbythemanufacturer;Instructionsforuse;Limbs;Loadingtests;Materials;Materialsspecification;Orthopaedics;Orthopedics;Orthoticdevices;Prostheticdevices;Resistance;Specification(approval);Sterility;Strengthofmaterials;Surfacetemperatures;Technicalaid;Testing
【摘要】:ThisInternationalStandardspecifiesrequirementsandtestmethodsforexternallimbprosthesesandexternalorthoses,includingthefollowingclassificationsfromISO9999:0603-0615Orthoses0618-0627LimbprosthesesItcoversstrength,materials,restrictionsonuse,riskandtheprovisionofinformationassociatedwiththenormalconditionsofuseofbothcomponentsandassembliesofcomponents.ThisInternationalStandarddoesnotcoverspecialseatingasitisnotclassifiedasanorthosisinISO9999anditisnotnormallybodyworn.NOTE1Itisintendedtocoverorthopaedicfootwear(classification0633)inthefuture.NOTE2TheapplicationofQualitySystemsasdescribedorreferredtoinISO13485andISO13488maybeappropriate.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40;11_180_10
【页数】:82P;A4
【正文语种】:英语