ASTM D4840-1999(2004) 保管系列程序抽样标准指南
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【英文标准名称】:StandardGuideforSamplingChain-of-CustodyProcedures
【原文标准名称】:保管系列程序抽样标准指南
【标准号】:ASTMD4840-1999(2004)
【标准状态】:现行
【国别】:
【发布日期】:1999
【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】:D19.02
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:职责;抽样方法
【英文主题词】:chainofcustody;custody;datadefensibility;validation
【摘要】:Chain-of-custodyproceduresareanecessaryelementinaprogramtoassureone’abilitytosupportdataandconclusionsadequatelyinalegalorregulatorysituation,butcustodydocumentationaloneisnotsufficient.Acompletedatadefensibilityschemeshouldbefollowed.Inapplyingthesamplechain-of-custodyproceduresinthisguide,itisassumedthatalloftheotherelementsofdatadefensibilityhavebeenapplied,ifapplicable.1.1Thisguidecontainsacomprehensivediscussionofpotentialrequirementsforasamplechain-of-custodyprogramanddescribestheproceduresinvolvedinsamplechain-of-custody.Thepurposeoftheseproceduresistoprovideaccountabilityforanddocumentationofsampleintegrityfromthetimesamplesarecollecteduntilsampledisposal.1.2Theseproceduresareintendedtodocumentsamplepossessionduringeachstageofasample'slifecycle,thatis,duringcollection,shipment,storage,andtheprocessofanalysis.1.3Samplechain-of-custodyisjustoneaspectofthelargerissueofdatadefensibility(see3.2.2andAppendixX1).1.4Asufficientchain-of-custodyprocess,thatis,onethatprovidessufficientevidenceofsampleintegrityinalegalorregulatorysetting,issituationallydependent.Theprocedurespresentedinthisguidearegenerallyconsideredsufficienttoassurelegaldefensibilityofsampleintegrity.Inagivensituation,lessstringentmeasuresmaybeadequate.Itistheresponsibilityoftheusersofthisguidetodeterminetheirexactneeds.Legalcounselmaybeneededtomakethisdetermination.1.5Becausethereisnodefinitiveprogramthatguaranteeslegaldefensibilityofdataintegrityinanygivensituation,thisguideprovidesadescriptionanddiscussionofacomprehensivelistofpossibleelementsofachain-of-custodyprogram,allofwhichhavebeenemployedinactualprogramsbutaregivenasoptionsforthedevelopmentofaspecificchain-of-custodyprogram.Inaddition,withinparticularchain-of-custodyelements,thisguideproscribescertainactivitiestoassurethatiftheseoptionsarechosen,theywillbeimplementedproperly.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A41
【国际标准分类号】:03_160
【页数】:8P.;A4
【正文语种】:
【原文标准名称】:保管系列程序抽样标准指南
【标准号】:ASTMD4840-1999(2004)
【标准状态】:现行
【国别】:
【发布日期】:1999
【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】:D19.02
【标准类型】:(Guide)
【标准水平】:()
【中文主题词】:职责;抽样方法
【英文主题词】:chainofcustody;custody;datadefensibility;validation
【摘要】:Chain-of-custodyproceduresareanecessaryelementinaprogramtoassureone’abilitytosupportdataandconclusionsadequatelyinalegalorregulatorysituation,butcustodydocumentationaloneisnotsufficient.Acompletedatadefensibilityschemeshouldbefollowed.Inapplyingthesamplechain-of-custodyproceduresinthisguide,itisassumedthatalloftheotherelementsofdatadefensibilityhavebeenapplied,ifapplicable.1.1Thisguidecontainsacomprehensivediscussionofpotentialrequirementsforasamplechain-of-custodyprogramanddescribestheproceduresinvolvedinsamplechain-of-custody.Thepurposeoftheseproceduresistoprovideaccountabilityforanddocumentationofsampleintegrityfromthetimesamplesarecollecteduntilsampledisposal.1.2Theseproceduresareintendedtodocumentsamplepossessionduringeachstageofasample'slifecycle,thatis,duringcollection,shipment,storage,andtheprocessofanalysis.1.3Samplechain-of-custodyisjustoneaspectofthelargerissueofdatadefensibility(see3.2.2andAppendixX1).1.4Asufficientchain-of-custodyprocess,thatis,onethatprovidessufficientevidenceofsampleintegrityinalegalorregulatorysetting,issituationallydependent.Theprocedurespresentedinthisguidearegenerallyconsideredsufficienttoassurelegaldefensibilityofsampleintegrity.Inagivensituation,lessstringentmeasuresmaybeadequate.Itistheresponsibilityoftheusersofthisguidetodeterminetheirexactneeds.Legalcounselmaybeneededtomakethisdetermination.1.5Becausethereisnodefinitiveprogramthatguaranteeslegaldefensibilityofdataintegrityinanygivensituation,thisguideprovidesadescriptionanddiscussionofacomprehensivelistofpossibleelementsofachain-of-custodyprogram,allofwhichhavebeenemployedinactualprogramsbutaregivenasoptionsforthedevelopmentofaspecificchain-of-custodyprogram.Inaddition,withinparticularchain-of-custodyelements,thisguideproscribescertainactivitiestoassurethatiftheseoptionsarechosen,theywillbeimplementedproperly.1.6Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:A41
【国际标准分类号】:03_160
【页数】:8P.;A4
【正文语种】:
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