【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


【英文标准名称】:LPGequipmentandaccessories-ConstructionandperformanceofLPGequipmentforautomotivefillingstations-Part1:Dispensers(includesAmendmentA1:2009);EnglishversionofDINEN14678-1:2009-08
【原文标准名称】:液化石油气(LPG)设备和附件.机动车加气站LPG设备的结构和性能.第1部分:分配器(包括补充件A1-2009).英文版本DINEN14678-1-2009-08
【标准号】:EN14678-1-2009
【标准状态】:现行
【国别】:
【发布日期】:2009-08
【实施或试行日期】:
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:区域;压缩气体;定义;输送设备;尺寸;距离;电气测试;设备;安装;防爆;装填填料装置;灌装设备;防火安全性;可燃性环境;燃气储罐;燃料气体;修车厂(商业的);气体压力容器;软管接头;着火性;装配;液化石油气;场所;作标记;机动车;露天;操作;压力容器;保护措施;路边加油站;安全工程;安全性措施;安全性要求;规范(验收);固定的;结构体系;水箱;试验;隔气层
【英文主题词】:Areas;Compressedgases;Definitions;Deliveryequipment;Dimensions;Distances;Electricaltesting;Equipment;Erection;Explosionprotection;Fillingdevices;Fillingplants;Firesafety;Flammableatmospheres;Fuelgastanks;Fuelgases;Garages(commercial);Gaspressurevessels;Hosenozzles;Ignitability;Installation;Liquefiedpetroleumgas;Locations;Marking;Motorcargases;Openair;Operation;Pressurevessels;Protectivemeasures;Roadsidepetrolpumps;Safetyengineering;Safetymeasures;Safetyrequirements;Specification(approval);Stationary;Structuralsystems;Tanks(containers);Testing;Vapourbarriers
【摘要】:
【中国标准分类号】:
【国际标准分类号】:75_200
【页数】:36P.;A4
【正文语种】:英语