NF J95-022/A1-2001 小艇.电气装置.周围可燃气体点燃的防护
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来源:标准资料网
【英文标准名称】:Smallcraft-Electricaldevices-Protectionagainstignitionofsurroundingflammablegases.
【原文标准名称】:小艇.电气装置.周围可燃气体点燃的防护
【标准号】:NFJ95-022/A1-2001
【标准状态】:现行
【国别】:法国
【发布日期】:2001-02-01
【实施或试行日期】:2001-02-05
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:小型船舶;点火防护装置;防火外壳;煤气;小型飞机;可燃的;防火;气体;规范;试验;试验;防火安全;船舶;电气设备;电气设备;防爆;易燃性;造船
【英文主题词】:
【摘要】:
【中国标准分类号】:U18
【国际标准分类号】:47_080
【页数】:5P;A4
【正文语种】:其他
【英文标准名称】:StandardGuideforAssessmentoftheUltraHighMolecularWeightPolyethylene(UHMWPE)UsedinOrthopedicandSpinalDevices
【原文标准名称】:对超高分子量聚乙烯评估(UHMWPE)用于脊柱骨科和设备的标准指南
【标准号】:ASTMF2759-2009
【标准状态】:现行
【国别】:美国
【发布日期】:2009
【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】:F04.11
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:
【英文主题词】:musculoskeletaljointreplacement;orthopedicdevice;spinaldevice;UHMWPE;ultra-highmolecularweightpolyethylene
【摘要】:ThisguideaimstoprovideguidanceforarangeofvariousassessmentsandevaluationstoaidinpreclinicalresearchanddevicedevelopmentofvariousUHMWPEcomponentsinorthopedicandspinaldevicesusedfortherepairofmusculoskeletaldisorders.Thisguideincludesbriefdescriptionsofvariousassessments,representativedata,processingconditions,andintendeduseoruses,aswellasthequalitativeandquantitativeanalysesoftheUHMWPEpowdertoafinishedproductcomponent.TheuserisencouragedtouseappropriateASTMInternationalandotherstandardstoconductthephysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEmaterials,devicecomponents,ordevicesbeforeassessmentofaninvivomodel.AssessmentsofUHMWPEshouldbeperformedinaccordancewiththeprovisionsof21CFR58wherefeasible.Studiestosupportinvestigationaldeviceexemption(IDE),premarketapproval(PMA),or510KsubmissionsshouldconformtoappropriateFoodandDrugAdministration(FDA)guidelinesforthedevelopmentofmedicaldevices.Assessmentswithphysical,chemical,mechanical,biocompatibility,andpreclinicaltestsonUHMWPEcomponentsarenotnecessarilypredictiveofhumanresultsandshouldbe,therefore,interpretedcautiouslywithrespecttopotentialapplicabilitytohumanconditions.ReferencedUHMWPEpublicationscanbefoundintheReferencessectionattheendofthisguideforfurtherreview.1.1Thisguidecoversgeneralguidelinesforthephysical,chemical,biocompatibility,mechanical,andpreclinicalassessmentsofultra-highmolecularweightpolyethylene(UHMWPE)inimplantableorthopedicandspinaldevicesintendedtoreplaceamusculoskeletaljoint.TheUHMWPEcomponentsmayincludeknee,hip,shoulder,elbow,ankle,totaldiscreplacement,toe,finger,andwristjointimplantdevices.ThisguidedoesnotcoverUHMWPEinfiberortapeforms.1.2ThisguideincludesadescriptionandrationaleofassessmentsforthevariousUHMWPEtypesandprocessingconditions.Assessmenttestingbasedonphysical,chemical,biocompatibility,mechanical,andpreclinicalanalysesarebrieflydescribedandreferenced.Theusershouldrefertospecifictestmethodsforadditionaldetails.1.3ThisguidedoesnotattempttodefinealloftheassessmentmethodsassociatedwithUHMWPEcomponentsinorthopedicandspinaldevices.1.4Units8212;ThevaluesgiveninSIunitsaretoberegardedasthestandard.Nootherunitsofmeasurementareincludedinthisstandard.1.5Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:5P.;A4
【正文语种】:英语
【英文标准名称】:Portablelead-acidcellsandbatteries(valve-regulatedtypes);part1:generalrequirements,functionalcharacteristics,methodsoftest(IEC61056-1:1991);GermanversionEN61056-1:1993
【原文标准名称】:便携式酸蓄电池和蓄电池组(阀调节型).第1部分:一般要求,功能特性.试验方法
【标准号】:DINEN61056-1-1994
【标准状态】:作废
【国别】:德国
【发布日期】:1994-05
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:作标记;型式;试验;蓄电池组;特性;规范(验收);名称与符号;电极;极性;便携的;酸性铅蓄电池;二次电池;硫酸;蓄电池;电池;电解质
【英文主题词】:polarity;secondarybatteries;testing;cells;marking;specification(approval);batteries;types;storagebatteries;electrodes;sulphuricacid;lead-acidbatteries;designations;portable;electrolytes;propertie
【摘要】:
【中国标准分类号】:K84
【国际标准分类号】:29_220_20
【页数】:6P;A4
【正文语种】:德语
