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【英文标准名称】:Rubberandplasticshosesandtubing-Measurementofflexibilityandstiffness-Part1:Bendingtestsatambienttemperature(ISO10619-1:2011);GermanversionENISO10619-1:2011
【原文标准名称】:橡胶和塑料软管和管材.曲挠性和刚性的测量.第1部分:在环境温度下的弯曲试验(ISO10619-1-2011).德文版本ENISO10619-1-2011
【标准号】:DINENISO10619-1-2012
【标准状态】:现行
【国别】:德国
【发布日期】:2012-03
【实施或试行日期】:
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Ambienttemperature;Bendtesting;Definitions;Flexibility;Hoses;Layers;Mechanicaltesting;Plastics;Plasticshose;Plasticsproducts;Properties;Rubberhoses;Rubberproducts;Testing;Vulcanizedrubber
【摘要】:
【中国标准分类号】:G42
【国际标准分类号】:23_040_70
【页数】:19P;A4
【正文语种】:德语


【英文标准名称】:Sterilizationofsingle-usemedicaldevicesincorporatingmaterialsofanimalorigin-Validationandroutinecontrolofsterilizationbyliquidsterilants
【原文标准名称】:使用液体化学灭菌剂对包括动物源材料在内的一次性使用医疗器具进行灭菌的确认和常规控制
【标准号】:ISO14160-1998
【标准状态】:作废
【国别】:国际
【发布日期】:1998-03
【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/TC198
【标准类型】:()
【标准水平】:()
【中文主题词】:动物产品;可处置的;证实;无菌设备;灭菌;一次性使用设备;液态材料;定义;定义;监督(认可);医疗产品
【英文主题词】:Animal;Animalproducts;Aseptic;Bacterialcount;Biologicalhazards;Calibration;Certification;Checks;Chemical;Chemicals;Clearing;Compatibility;Definitions;Developments;Disposable;Disposables;Efficiency;Equipmentforsingleuse;Evaluations;Fabrics;Germs;Guidebooks;Incubation;Information;Insulations;Kinetics;Liquid;Liquidmaterials;Liquids;Loading;Media;Medicaldevices;Medicalproducts;Methods;Microbiological;Neutralization;Performance;Personnel;Production;Products;Screening-method;Sterileequipment;Sterilization(hygiene);Surveillance(approval);Training;Use;Validation
【摘要】:ThisInternationalStandardspecifiesrequirementsforthedevelopment,validation,processcontrolandmonitoringofthesterilization,bytheuseofliquidchemicalsterilants,ofsingle-usemedicaldevicescomprising,inwholeorinpart,materialsofanimalorigin.ThisInternationalStandarddoesnotapplytomaterialofhumanorigin.ThisInternationalStandarddoesnotdescribeaqualityassurancesystemforthecontrolofallstagesofmanufacture.NOTE1Attentionisdrawntothestandardsforqualitysystems(seeISO9001andISO13485orISO9002andISO13488)whichcanbeusedinthecontrolofallstagesofmanufactureincludingthesterilizationprocess.ThisInternationalStandarddoesnotdescribeteststoestablishtheeffectsofanychosensterilizationmethoduponthefitnessforuseofthemedicaldevice.NOTE2Suchtestingisacrucialpartofthedesignanddevelopmentofamedicaldevice.ThisInternationalStandarddoesnotdescribemethodsforthevalidationoftheinactivationofviruses.NOTE3Indevelopingamethodforprocessingmedicaldevicescontainingmaterialsofanimalorigin,considerationoftheeffectsofliquidchemicalsterilizationonpotentialviralcontaminantswillalsobenecessarybecauseofthesourceofmaterialsusedinthemanufactureoftheseparticularmedicaldevices.TheimportanceofvalidationofviralinactivationforprocesseswithinthescopeofthisInternationalStandardisrecognized.ThisaspectisexcludedfromthisInternationalStandard;aseparateEuropeanStandardisinpreparation(EN12442-3).NOTE4Liquidchemicalsterilantstraditionallyemployedtosterilizeanimaltissuesinmedicaldevicesmaynotbeeffectiveininactivatingthecausativeagentsoftransmissablespongiformencephalopathiessuchasbovinespongiformencephalopathy(BSE),orscrapie.SatisfactoryvalidationinaccordancewiththisInternationalStandardshouldnotbeassumedtodemonstrateinactivationofinfectiveagentsofthistype.ThisInternationalStandarddoesnotcoverthelevelofresidualsterilantwithinmedicaldevices.NOTE5ISO14538isconcernedwiththisissue.
【中国标准分类号】:C47
【国际标准分类号】:11_080_30
【页数】:21P.;A4
【正文语种】:英语