DIN EN ISO 10993-18-2009 医疗装置的生物学评定.第18部分:材料的化学表征(ISO10993-18-2005);德文版本ENISO10993-18-2009

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【英文标准名称】:Biologicalevaluationofmedicaldevices-Part18:Chemicalcharacterizationofmaterials(ISO10993-18:2005);EnglishversionofDINENISO10993-18:2009-08
【原文标准名称】:医疗装置的生物学评定.第18部分:材料的化学表征(ISO10993-18-2005);德文版本ENISO10993-18-2009
【标准号】:DINENISO10993-18-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-08
【实施或试行日期】:2009-08-01
【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】:合金;应用;生物测定;生物试验;陶瓷;特性;化学的;化学分析和试验;化学性质;定义;测定;评定;健康危害;识别;医疗器械;医疗设备;医疗产品;金属;方法;规范(验收);试验
【英文主题词】:Alloys;Applications;Bioassay;Biologicaltests;Ceramics;Characteristics;Chemical;Chemicalanalysisandtesting;Chemicalproperties;Definitions;Determination;Evaluations;Healthhazards;Identification;Medicaldevices;Medicalequipment;Medicalproducts;Metals;Methods;Specification(approval);Testing
【摘要】:ThispartofISO10993describesaframeworkfortheidentificationofamaterialandtheidentificationandquantificationofitschemicalconstituents.Thechemicalcharacterizationinformationgeneratedcanbeusedforarangeofimportantapplications,forexample:--Aspartofanassessmentoftheoverallbiologicalsafetyofamedicaldevice(ISO10993-1and14971).--Measurementofthelevelofaleachablesubstanceinamedicaldeviceinordertoallowtheassessmentofcompliancewiththeallowablelimitderivedforthatsubstancefromhealthbasedriskassessment(ISO10993-17).--Judgingequivalenceofaproposedmaterialtoaclinicallyestablishedmaterial.--Judgingequivalenceofafinaldevicetoaprototypedevicetochecktherelevanceofdataonthelattertobeusedtosupporttheassessmentoftheformer.--Screeningofpotentialnewmaterialsforsuitabilityinamedicaldeviceforaproposedclinicalapplication.ThispartofISO10993doesnotaddresstheidentificationorquantificationofdegradationproducts,whichiscoveredinISO10993-9,ISO10993-13,ISO10993-14andISO10993-15.TheISO10993seriesofstandardsisapplicablewhenthematerialordevicecomesintocontactwiththebodydirectlyorindirectly(see4.2.1ofISO10993-1:2003).ThispartofISO10993isintendedforsuppliersofmaterialsandmanufacturersofmedicaldevices,whencarryingoutabiologicalsafetyassessment.
【中国标准分类号】:C30
【国际标准分类号】:11_100_20
【页数】:27P.;A4
【正文语种】:英语

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上一篇: DIN EN ISO 8835-2-2009 吸入式麻醉剂系统.第2部分:麻醉呼吸系统(ISO8835-2-2007);德文版本ENISO8835-2-2009
下一篇: DIN EN ISO 21534-2009 非活性外科植入物.关节替代植入物.特殊要求(ISO21534-2007);德文版本ENISO21534-2009

Product Code:SAE AMS3811
Title:Rods, Aramid Fiber, Polyester Resin Coated, Pultrusion
Issuing Committee:Ams P Polymeric Materials Committee
Scope: This specification covers coated round rods fabricated by the pultrusion process from aramid fibers and a weather-resistant polyester resin binder in the form of straight lengths or in coils. These rods have been used typically for nonconductive tension elements in antenna supports where superior long-term weather resistance and extremely light weight are required, but usage is not limited to such applications.
Rationale: This specification covers coated round rods fabricated by the pultrusion process from aramid fibers and a weather-resistant polyester resin binder in the form of straight lengths or in coils. These rods have been used typically for nonconductive tension elements in antenna supports where superior long-term weather resistance and extremely light weight are required, but usage is not limited to such applications.【英文标准名称】:Informationtechnology-Securitytechniques-Keymanagement-Part2:Mechanismsusingsymmetrictechniques
【原文标准名称】:信息技术.保密技术.关键管理.第2部分:使用对称技术机制
【标准号】:ANSI/INCITS/ISO/IEC11770-2-2009
【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】:美国国家标准学会(US-ANSI)
【起草单位】:ANSI
【标准类型】:()
【标准水平】:()
【中文主题词】:算法;可靠性测试;数据处理;数据保护;数据传输;定义;信息交换;信息技术;IT安全;管理;安全工程
【英文主题词】:Algorithms;Authenticitytests;Dataprocessing;Dataprotection;Datatransmission;Definitions;Informationinterchange;Informationtechnology;ITsecurity;Management;Safetyengineering
【摘要】:ISO/IEC11770isconcernedwiththemanagementofcryptographickeys.ISO/IEC11770-2:2008specifiesaseriesof13mechanismsforestablishingsharedsecretkeysusingsymmetriccryptography.Thesemechanismsaddressthreedifferentenvironmentsfortheestablishmentofsharedsecretkeys:point-to-pointkeyestablishmentschemes,mechanismsusingaKeyDistributionCentre(KDC),andtechniquesthatuseaKeyTranslationCentre(KTC).ISO/IEC11770-2:2008describesthecontentofmessageswhichcarrykeyingmaterialorarenecessarytosetuptheconditionsunderwhichthekeyingmaterialcanbeestablished.
【中国标准分类号】:L70
【国际标准分类号】:35_040
【页数】:
【正文语种】:英语