BS EN 13612-2002 体外诊断医疗装置的性能评估

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【英文标准名称】:Performanceevaluationofinvitrodiagnosticmedicaldevices
【原文标准名称】:体外诊断医疗装置的性能评估
【标准号】:BSEN13612-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-05-07
【实施或试行日期】:2002-05-07
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:自测;验证;在实验室条件下;效率;产品信息;质量保证;医学科学;实验室条件下诊断;评定;诊断;实验室医学;定义;定义;试剂;质量评定;诊断设备;作标记
【英文主题词】:
【摘要】:ThisEuropeanStandardappliestotheperformanceevaluationofinvitrodiagnosticmedicaldevices(IVDMDs)includingIVDMDsforself-testing.Itspecifiestheresponsibilitiesandgeneralrequirementsfortheplanning,conduct,assessmentanddocumentationofaperformanceevaluationstudybythemanufacturer.ItdoesnotapplytospecificevaluationplansforcertainIVDMDsoraspecificuse.NOTEForaselectionofpublicationsonspecificevaluationplansseeBibliography.Whereamanufacturermaintainsaqualitysystemthisstandardaddressesthecompliancewith"designvalidation"and"designchanges"asdescribedinENISO9001,EN46001andEN928especiallyconsideringthenatureanduseofIVDMDs.Inparticular,thisstandardappliestoIVDMDsto-showevidencetonotifiedbodiesandnationalauthoritiesbyresultsofaperformanceevaluationthattheIVDMDperformsasclaimedbythemanufacturer,-establishadequateperformanceevaluationdataoriginatingfromappropriatestudiesorresultingfromavailableliterature,andto-satisfytherequirementsofaqualitysystemfordesignvalidation.
【中国标准分类号】:C36
【国际标准分类号】:11_100_10
【页数】:18P;A4
【正文语种】:英语


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基本信息
标准名称:港口设施保安评估导则
发布部门:中华人民共和国交通运输部
发布日期:2010-04-22
实施日期:2010-08-01
首发日期:
作废日期:
出版社:人民交通出版社
出版日期:2010-08-01
书号:15114.1500
适用范围

本标准规定了《中华人民共和国港口设施保安规则》规定的保安评估工作。

前言

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目录

1 范围 2 规范性引用文件 3 术语和定义 4 港口设施保安评估工作内容 5 港口设施保安评估报告的编制 6 港口设施保安评估工作程序及报告格式 附录

引用标准

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所属分类: 工程建设 原材料工业及通信 广播工程 石油工程
【英文标准名称】:Industrialcommunicationnetworks-Fieldbusspecifications-Part5-2:Applicationlayerservicedefinition-Type2elements(IEC61158-5-2:2007);EnglishversionEN61158-5-2:2008,onlyonCD-ROM
【原文标准名称】:工业通讯网络.现场总线规范.第5-2部分:应用层设备定义.2型元件.仅为CD-ROM
【标准号】:DINEN61158-5-2-2008
【标准状态】:作废
【国别】:德国
【发布日期】:2008-09
【实施或试行日期】:2008-09-01
【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】:应用层;应用;总线系统;总线;电路网络;通信;计算机应用;计算机控制;控制;控制设备;控制系统;控制工艺学;数据总线;数据通信;数据交换;数据传输线;数据连接系统;数据网络;数据处理;数据设备;数据传送;数据传输控制规程;定义;数字的;数字数据;数字工程;电子数据处理;电气工程;电子仪器;电子系统;英语;现场总线;制导系统;工业的;工业设施;信息交换;信息处理;信息技术;接口(数据处理);开放系统互连;操作技术;OSI;过程控制工程;设备;规范;规范(验收);传输媒质
【英文主题词】:Applicationlayer;Applications;Bussystems;Buses(dataprocessing);Circuitnetworks;Communication;Computerapplications;Computerizedcontrol;Control;Controlequipment;Controlsystems;Controltechnology;Databus;Datacommunication;Dataexchange;Dataline;Datalinksystem;Datanetwork;Dataprocessing;Dataservices;Datatransfer;Datatransmissioncontrolprocedures;Definition;Definitions;Digital;Digitaldata;Digitalengineering;EDP;Electricalengineering;Electronicinstruments;Electronicsystems;Englishlanguage;Fieldbus;Guidancesystems;Industrial;Industrialfacilities;Informationinterchange;Informationprocessing;Informationtechnology;Interfaces(dataprocessing);Opensystemsinterconnection;Operationaltechniques;OSI;Processcontrolengineering;Services;Specification;Specification(approval);Transmissionmedia
【摘要】:1.1OverviewThefieldbusapplicationlayer(FAL)providesuserprogramswithameanstoaccessthefieldbuscommunicationenvironment.Inthisrespect,theFALcanbeviewedasa“windowbetweencorrespondingapplicationprograms.”Thisstandardprovidescommonelementsforbasictime-criticalandnon-time-criticalmessagingcommunicationsbetweenapplicationprogramsinanautomationenvironmentandmaterialspecifictoType2fieldbus.Theterm“time-critical”isusedtorepresentthepresenceofatime-window,withinwhichoneormorespecifiedactionsarerequiredtobecompletedwithsomedefinedlevelofcertainty.Failuretocompletespecifiedactionswithinthetimewindowrisksfailureoftheapplicationsrequestingtheactions,withattendantrisktoequipment,plantandpossiblyhumanlife.ThisstandarddefinesinanabstractwaytheexternallyvisibleserviceprovidedbytheType2fieldbusapplicationlayerintermsofa)anabstractmodelfordefiningapplicationresources(objects)capableofbeingmanipulatedbyusersviatheuseoftheFALservice,b)theprimitiveactionsandeventsoftheservice;c)theparametersassociatedwitheachprimitiveactionandevent,andtheformwhichtheytake;andd)theinterrelationshipbetweentheseactionsandevents,andtheirvalidsequences.Thepurposeofthisstandardistodefinetheservicesprovidedto1)theFALuserattheboundarybetweentheuserandtheapplicationlayerofthefieldbusreferencemodel,and2)SystemsManagementattheboundarybetweentheapplicationlayerandSystemsManagementofthefieldbusreferencemodel.ThisstandardspecifiesthestructureandservicesoftheType2fieldbusapplicationlayer,inconformancewiththeOSIBasicReferenceModel(ISO/IEC7498)andtheOSIapplicationlayerstructure(ISO/IEC9545).FALservicesandprotocolsareprovidedbyFALapplication-entities(AE)containedwithintheapplicationprocesses.TheFALAEiscomposedofasetofobject-orientedapplicationserviceelements(ASEs)andalayermanagemententity(LME)thatmanagestheAE.TheASEsprovidecommunicationservicesthatoperateonasetofrelatedapplicationprocessobject(APO)classes.OneoftheFALASEsisamanagementASEthatprovidesacommonsetofservicesforthemanagementoftheinstancesofFALclasses.Althoughtheseservicesspecify,fromtheperspectiveofapplications,howrequestandresponsesareissuedanddelivered,theydonotincludeaspecificationofwhattherequestingandrespondingapplicationsaretodowiththem.Thatis,thebehavioralaspectsoftheapplicationsarenotspecified;onlyadefinitionofwhatrequestsandresponsestheycansend/receiveisspecified.1.2SpecificationsTheprincipalobjectiveofthisstandardistospecifythecharacteristicsofconceptualapplicationlayerservicessuitablefortime-criticalcommunications,andthussupplementtheOSIBasicReferenceModelinguidingthedevelopmentofapplicationlayerprotocolsfortime-criticalcommunications.Asecondaryobjectiveistoprovidemigrationpathsfrompreviously-existingindustrialcommunicationsprotocols.ItisthislatterobjectivewhichgivesrisetothediversityofservicesstandardizedasthevariousTypesofIEC61158,andthecorrespondingprotocolsstandardizedinsubpartsofIEC61158-6.Thisspecificationmaybeusedasthebasisforformalapplicationprogramminginterfaces.Nevertheless,itisnotaformalprogramminginterface,andanysuchinterfacewillneedtoaddressimplementationissuesnotcoveredbythisspecification,includinga)thesizesandoctetorderingofvariousmulti-octetserviceparameters,andb)thecorrelationofpairedrequestandconfirm,orindicationandresponse,primitives.
【中国标准分类号】:P76;N18
【国际标准分类号】:35_100_70;35_160
【页数】:190P.;A4
【正文语种】:英语