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JIS T0816-1-2010 保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求

作者:标准资料网 时间:2024-05-15 02:21:09  浏览:8557   来源:标准资料网
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【英文标准名称】:Sterilizationofhealthcareproducts-moistheat--Part1:Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:保健产品的灭菌.湿热.第1部分:医疗机械消毒过程的制定、确认和常规控制的要求
【标准号】:JIST0816-1-2010
【标准状态】:现行
【国别】:
【发布日期】:2010-02-25
【实施或试行日期】:
【发布单位】:日本工业标准调查会(JP-JISC)
【起草单位】:TechnicalCommitteeonMedicalEquipment
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:C04
【国际标准分类号】:11_080_01
【页数】:40P;A4
【正文语种】:日语


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【英文标准名称】:Multi-purposechocks
【原文标准名称】:多用途导索孔
【标准号】:DIN81915-1978
【标准状态】:作废
【国别】:德国
【发布日期】:1978-05
【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】:尺寸;设计;砝码;锚链孔;造船;材料;作标记
【英文主题词】:shipbuilding;hawses;dimensions;materials;weights;design;marking
【摘要】:
【中国标准分类号】:U22
【国际标准分类号】:5080
【页数】:5P;A4
【正文语种】:德语


【英文标准名称】:StandardPracticeforFluorescentUltraviolet(UV)ExposureofPhotodegradablePlastics
【原文标准名称】:照相级塑料制品的荧光紫外线曝光的标准实施规程
【标准号】:ASTMD5208-2009
【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】:D20.96
【标准类型】:(Practice)
【标准水平】:()
【中文主题词】:
【英文主题词】:degradation;exposure;fluorescentUV;lightexposure;ultraviolet;Degradation--plastics;FluorescentUV-lightapparatus;Lightexposure--plastics;Photodegradation;Ultraviolet(UV)analysis--plastics;NumberCode83.080.01(Plastingeneral)
【摘要】:Materialsmadefromphotodegradableplasticsareintendedtoshowrelativelyrapiddeteriorationofchemical,physical,andmechanicalpropertieswhenexposedtolight,heat,andwaterafterfulfillingtheirintendedpurpose.Thispracticeisintendedtoinducepropertychangesassociatedwithconditionsthatmightbeexperiencedwhenthematerialisdiscardedaslitter,includingtheeffectsofsunlight,moisture,andheat.Theexposureusedinthispracticeisnotintendedtosimulatethedeteriorationcausedbylocalizedweatherphenomenasuchasatmosphericpollution,biologicalattack,andsaltwaterexposure.Cautions8212;Variationinresultsmaybeexpectedwhenoperatingconditionsarevariedwithintheacceptedlimitsofthispractice.Therefore,noreferencetotheuseofthispracticeshouldbemadeunlessaccompaniedbyareportpreparedinaccordancewithSection9thatdescribesthespecificoperatingconditionsused.RefertoPracticeG151fordetailedinformationonthecaveatsapplicabletouseofresultsobtainedinaccordancewiththispractice.Note38212;Additionalinformationonsourcesofvariabilityandonstrategiesforaddressingvariabilityinthedesign,executionanddataanalysisoflaboratoryacceleratedexposuretestsisfoundinGuideG141.Exposureofasimilarmaterialofknownperformance(acontrol)atthesametimeasthetestspecimensprovidesastandardforcomparativepurposes.Useofacontroltorankthestabilityoftestmaterialsgreatlyimprovesagreementbetweendifferentlaboratories.,Itisrecommendedthatatleastthreereplicatesofeachmaterialevaluatedbeexposedtoallowforstatisticalevaluationofresults.TestresultswilldependuponthecarethatistakentooperatetheequipmentinaccordancewithPracticeG154.Significantfactorsincluderegulationoflinevoltage,temperatureoftheroominwhichthedeviceoperates,temperaturecontrol,andconditionandageofthelamps.1.1ThispracticecoversthespecificproceduresapplicableforfluorescentUltraviolet(UV)exposureofphotodegradableplasticsconductedinaccordancewithPracticesG151andG154.Thispracticealsocoversthepreparationoftestspecimensandtheevaluationoftestresults.Note18212;PreviousversionsofthispracticereferencedfluorescentUVdevicesdescribedbyPracticeG53,whichdescribedveryspecificequipmentdesigns.PracticeG53hasbeenwithdrawnandreplacedbyPracticeG151,whichdescribesperformancecriteriaforallexposuredevicesthatuselaboratorylightsourcesandbyPracticeG154,whichgivesrequirementsforexposingnonmetallicmaterialsinfluorescentUVdevices.1.2PracticeD4329coversfluorescentUVexposuresofplasticsintendedforlongtermuseinoutdoorapplications.1.3ThevaluesstatedinSIunitsaretoberegardedasstandard.Thevaluesgiveninparenthesesareforinformationonly.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyproblems,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.Note28212;ThereisnoknownISOequivalenttothispractice.
【中国标准分类号】:G31
【国际标准分类号】:
【页数】:5P.;A4
【正文语种】:英语



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