DIN EN 1041-2008 由医疗装置制造商提供的信息
时间:2024-05-10 06:14:18 来源: 标准资料网 作者：标准资料网 阅读：9830
【英文标准名称】:Informationsuppliedbythemanufacturerofmedicaldevices;GermanversionEN1041:2008
【原文标准名称】:由医疗装置制造商提供的信息
【标准号】:DINEN1041-2008
【标准状态】:现行
【国别】:德国
【发布日期】:2008-11
【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】:附件;制造日期;定义;绷扎材料;企业;外科植入物;信息;使用说明书;作标记;医疗设备;医疗器械;医疗产品;医学科学;医疗技术学;产品信息;产品;保障;规范(验收);手术敷料;术语
【英文主题词】:Accessories;Dataofthemanufacturer;Definition;Definitions;Dressingmaterials;Enterprises;Implants(surgical);Information;Instructionsforuse;Marking;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Medicaltechnology;Productinformation;Products;Provision;Specification(approval);Surgicaldressings;Terminology
【摘要】:ThisstandardspecifiesrequirementsforinformationtobesuppliedbyamanufacturerformedicaldevicesregulatedbyCouncilDirective90/385/EECrelatingtoactiveimplantablemedicaldevicesandCouncilDirective93/42/EECconcerningmedicaldevices.Itdoesnotspecifythelanguagetobeusedforsuchinformadon,nordoesitspecifythemeansbywhichtheinformationistobesupplied.ItisalsointendedtocomplementthespecificrequirementsofthecitedEUDirectivesonmedicaldevicesbyprovidingguidanceonmeansbywhichcertainrequirementscanbemet.Ifamanufacturerfollowsthesemeans,theywillprovideapresumptionofconformitywiththerelevantEssentialRequirementsregardinginformationtobesupplied.Thisstandarddoesnotcoverrequirementsforprovisionofinformationforinvitrodiagnosticmedicaldevices,whicharecoveredbyotherlabellingstandards(seeBibliography).NOTEWhennationaltranspositionsoftheDirectivesspecifythemeansbywhichinformationshallbesupplied,thisstandarddoesnotprovidederogationfromtheserequirementsforthatcountry.
【中国标准分类号】:C04
【国际标准分类号】:01_110;11_040_01;11_120_01
【页数】:32P.;A4
【正文语种】:德语
【英文标准名称】:StandardTestMethodforTensilePropertiesofThinPlasticSheeting
【原文标准名称】:塑料薄板材抗拉特性的标准试验方法
【标准号】:ASTMD882-2001
【标准状态】:作废
【国别】:美国
【发布日期】:2001
【实施或试行日期】:
【发布单位】:美国材料与试验协会(ASTM)
【起草单位】:ASTM
【标准类型】:()
【标准水平】:()
【中文主题词】:试验;塑料
【英文主题词】:testing;plastics
【摘要】:
【中国标准分类号】:G33
【国际标准分类号】:83_140_10
【页数】:9P;A4
【正文语种】:英语
【英文标准名称】:StandardSpecificationforIndustrialPlatinumResistanceThermometers
【原文标准名称】:工业用铂阻尼式温度计标准规范
【标准号】:ASTME1137/E1137M-2008
【标准状态】:现行
【国别】:美国
【发布日期】:2008
【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】:E20.03
【标准类型】:(Specification)
【标准水平】:()
【中文主题词】:
【英文主题词】:ITS-90;metalsheath;platinumresistancethermometer;PRT
【摘要】:Thisspecificationiswrittentoprovidecommonterminology,resistanceversustemperaturecharacteristics,accuracyclassification,andinspectionrequirementsforaspecifiedconfigurationofatypicalindustrialplatinumresistancethermometer(PRT).Thisspecificationmaybeusedaspartofthedocumentationtosupportnegotiationsforthepurchaseanddiscussionofsuchthermometers.1.1Thisspecificationcoverstherequirementsformetal-sheathedindustrialplatinumresistancethermometers(PRT''s)suitablefordirectimmersiontemperaturemeasurement.ItappliestoPRT''swithanaveragetemperaturecoefficientofresistancebetween0and100x00B0;Cof0.385%/x00B0;Candnominalresistanceat0x00B0;Cof100x03A9;orotherspecifiedvalue.ThisspecificationcoversPRT''ssuitableforallorpartofthetemperaturerangex2212;200to650x00B0;C.Theresistance-temperaturerelationshipandtolerancesarespecifiedaswellasphysical,performance,andtestingrequirements.1.2ThevaluesoftemperatureinthisspecificationarebasedontheInternationalTemperatureScaleof1990(ITS-90).1.3Thevaluesstatedininch-poundunitsorSI(metric)unitsmayberegardedseparatelyasstandard.Thevaluesstatedineachsystemarenotexactequivalents,andeachsystemshallbeindependentoftheother.1.4Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:N11
【国际标准分类号】:17_200_20
【页数】:7P.;A4
【正文语种】:英语