BS EN 868-1-1997 准备进行消毒的医疗装置用的包装材料和系统.一般要求和试验方法
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【英文标准名称】:Packagingmaterialsandsystemsformedicaldeviceswhicharetobesterilized-Generalrequirementsandtestmethods
【原文标准名称】:准备进行消毒的医疗装置用的包装材料和系统.一般要求和试验方法
【标准号】:BSEN868-1-1997
【标准状态】:作废
【国别】:英国
【发布日期】:1997-12-15
【实施或试行日期】:1997-12-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:密封件;捆扎;包装;空气;灭菌;质量控制;设计;性能试验;包装件;医疗设备;无菌设备;渗透性测量;医疗器械;可混用性;包装材料;兼容性;性能;渗透率;漏泄试验
【英文主题词】:
【摘要】:1ThisEuropeanStandardspecifiestherequirementsandtestmethodsforpackagingmaterialsandsystems:-whichareusedforpackagingofmedicaldeviceswhicharetobeterminallysterilized;and-whichareintendedtomaintainsterilityofthedevice.NOTE1.ThisstandardhasbeendevelopedasameanstoshowcompliancewithrelevantEuropeanDirectives.Ifhealthcarefacilitiese.g.hospitalsdonotplacemedicaldevicesonthemarket,theyarenotcoveredbytheseDirectives.Nevertheless,suchhealthcarefacilitiescanfulfilthesamerequirementsasmanufacturersbutcanusealternativemeanstodemonstrateconformitytothisstandard.NOTE2.CompliancewithotherPartsofprEN868seriescanbeusedtodemonstratecompliancewithoneormoreoftherequirementsofthisstandard.2Thisstandarddoesnotapplytopackagingmaterialsandsystemsusedforpackagingasepticallymanufacturedproducts.3ThisEuropeanStandarddoesnotdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.NOTE.Attentionisdrawntothestandardsforqualitysystems(seee.g.ENISO9001,ENISO9002,EN46001orEN46002)whichcontrolallstagesofmanufactureincludingthesterilizationprocess.Itisnotarequirementofthisstandardtohaveacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemcanbeapplied.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:20P;A4
【正文语种】:英语
【原文标准名称】:准备进行消毒的医疗装置用的包装材料和系统.一般要求和试验方法
【标准号】:BSEN868-1-1997
【标准状态】:作废
【国别】:英国
【发布日期】:1997-12-15
【实施或试行日期】:1997-12-15
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:密封件;捆扎;包装;空气;灭菌;质量控制;设计;性能试验;包装件;医疗设备;无菌设备;渗透性测量;医疗器械;可混用性;包装材料;兼容性;性能;渗透率;漏泄试验
【英文主题词】:
【摘要】:1ThisEuropeanStandardspecifiestherequirementsandtestmethodsforpackagingmaterialsandsystems:-whichareusedforpackagingofmedicaldeviceswhicharetobeterminallysterilized;and-whichareintendedtomaintainsterilityofthedevice.NOTE1.ThisstandardhasbeendevelopedasameanstoshowcompliancewithrelevantEuropeanDirectives.Ifhealthcarefacilitiese.g.hospitalsdonotplacemedicaldevicesonthemarket,theyarenotcoveredbytheseDirectives.Nevertheless,suchhealthcarefacilitiescanfulfilthesamerequirementsasmanufacturersbutcanusealternativemeanstodemonstrateconformitytothisstandard.NOTE2.CompliancewithotherPartsofprEN868seriescanbeusedtodemonstratecompliancewithoneormoreoftherequirementsofthisstandard.2Thisstandarddoesnotapplytopackagingmaterialsandsystemsusedforpackagingasepticallymanufacturedproducts.3ThisEuropeanStandarddoesnotdescribeaqualityassurancesystemforcontrolofallstagesofmanufacture.NOTE.Attentionisdrawntothestandardsforqualitysystems(seee.g.ENISO9001,ENISO9002,EN46001orEN46002)whichcontrolallstagesofmanufactureincludingthesterilizationprocess.Itisnotarequirementofthisstandardtohaveacompletequalitysystemduringmanufacturebutcertainelementsofsuchasystemcanbeapplied.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:20P;A4
【正文语种】:英语
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