【英文标准名称】:StandardPracticeforEvaluatingandSpecifyingImplantableShuntAssembliesforNeurosurgicalApplication
【原文标准名称】:神经外科用可植入分路组件的评定和确定标准实施规程
【标准号】:ASTMF647-1994(2006)
【标准状态】:现行
【国别】:
【发布日期】:1994
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:F04.31
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:使用;医疗设备;评定;规范;外科植入物;医学科学
【英文主题词】:anti-sipondevice;bio-compatibility;compatibility;hydrocephalus;magneticresonanceimaging(MRI);shunt;shuntassembly
【摘要】:Thispracticeprovidesminimumrequirementsfortheensuranceofsafetyandefficacy.Itprovidesacommonlanguagewherebythefunctionofthesesurgicalimplantsisdescribed.1.1Thispracticecoversrequirementsfortheevaluationandspecificationofimplantableshuntsasrelatedtoresistancetoflow,directionofflow,materials,radiopacity,mechanicalproperties,finish,sterility,andlabelingofshuntassemblies.1.2Devicestowhichthispracticeisapplicableinclude,butarenotlimitedto,thosethataretemporarilyimplantedtoeffectexternaldrainage;orpermanentlyimplantedtoeffectshuntingoffluidfromacerebralventricle,acyst,thesubarachnoidspacetotheperitonealcavity,thevenouscirculation,orsomeothersuitableinternaldeliverysite,andintracranialbypass.1.3LimitationsAlthoughthispracticeincludesastandardtestmethodfortheevaluationofpressure/flowcharacteristicsofshuntsorshuntcomponents,itdoesnotincludespecificpressure/flowrequirements.1.4Thefollowingcomponents,thatindividuallyorincombinationcompriseshuntassemblies,areconsideredtobewithinthescopeofthispractice:catheters(suchasatrial,peritoneal,ventricular),connectors,implantableaccessorydevices(suchasantisiphondevicesandreservoirs),valvedcathetersandvalves.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Note1Thefollowingstandardscontainprovisionsthat,throughreferenceinthistext,constituteprovisionsofthispractice.Atthetimeofpublication,theeditionsindicatedarevalid.Allstandardsaresubjecttorevision,andpartiestoagreementsbasedonthispracticeareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthestandardsindicatedbelow.Devicesorcomponents,orboth,whosestructuresarecomparabletothatoutlinedinthesestandardsareacceptable.1.5Thistestmethodprovidestheprocedureandacceptancecriteriauponwhichajudgmentofacceptableradiopacitycanbebasedandlabelingclaimssubstantiated.
【中国标准分类号】:C35
【国际标准分类号】:11_040_40
【页数】:12P.;A4
【正文语种】:

标准名称：	调压器试验导则 第一部分:接触、接触自动调压器试验导则
中标分类：	电工 >> 输变电设备 >> 变压器
替代情况：	被JB/T 7070.1-2002代替
发布日期：
实施日期：	1994-01-01
首发日期：
作废日期：
出版日期：
页数：	8页

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