ANSI/AAMI/ISO 13408-7-2012 保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工
时间:2024-05-06 05:10:18 来源: 标准资料网 作者：标准资料网 阅读：8229
【英文标准名称】:Asepticprocessingofhealthcareproducts-Part7:Alternativeprocessesforatypicalmedicaldevicesandcombinationproducts
【原文标准名称】:保健产品的无菌加工.第7部分:非典型医疗设备和组合产品用替换加工
【标准号】:ANSI/AAMI/ISO13408-7-2012
【标准状态】:现行
【国别】:美国
【发布日期】:2012
【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】:防腐剂;清洁处理;定义(术语);医疗卫生事业;医疗设备;医疗器械;医学科学;医疗技术学;质量保证;规范(验收);无菌
【英文主题词】:Aseptic;Cleaning;Definitions;Healthservices;Medicaldevices;Medicalinstruments;Medicalsciences;Medicaltechnology;Qualityassurance;Specification(approval);Sterility
【摘要】:SpecifiesrequirementsandprovidesguidanceonalternativeapproachestoprocesssimulationsforthequalificationoftheasepticprocessingofatypicalmedicaldevicesandcombinationproductsthatcannotbeterminallysterilizedandwheretheprocesssimulationapproachaccordingtoAAMI/ISO13408-1cannotbeapplied.
【中国标准分类号】:C50
【国际标准分类号】:11_080_01
【页数】:
【正文语种】:英语
【英文标准名称】:IncandescentLamps-A,G,PS,andSimilarShapeswithE26MediumScrewBases
【原文标准名称】:白炽灯.带E26中型螺纹灯座的A、G、PS和类似形状的白炽灯特性
【标准号】:ANSIC78.20-2003
【标准状态】:现行
【国别】:美国
【发布日期】:2003
【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】:NEMA(ASCC78)
【标准类型】:()
【标准水平】:()
【中文主题词】:白炽灯;灯
【英文主题词】:Incandescentlamps;Lamps
【摘要】:ANSIC78.20-ThisstandardsetsforthphysicalandelectricalcharacteristicsofthegroupofincandescentlampsthathaveA,G,PS,andsimilarbulbshapeswithE26singleanddoublecontactmediumscrewbasesincludingthereducedwattageversions.Onl
【中国标准分类号】:K71
【国际标准分类号】:29_140_20
【页数】:
【正文语种】:英语
【英文标准名称】:Industrialcommunicationnetworks-Fieldbusspecifications-Part5-18:Applicationlayerservicedefinition-Type18elements
【原文标准名称】:工业通讯网络.现场总线规范.第5-18部分:应用层设备定义.18型元件
【标准号】:IEC61158-5-18-2007
【标准状态】:作废
【国别】:国际
【发布日期】:2007-12
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/SC65C
【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;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;服务设施;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;Definitions;Digital;Digitaldata;Digitalengineering;EDP;Electronicinstruments;Electronicsystems;Englishlanguage;Fieldbus;Guidancesystems;Industrial;Industrialfacilities;Informationinterchange;Informationprocessing;Informationtechnology;Interfaces(dataprocessing);Opensystemsinterconnection;Operationaltechniques;OSI;Physicallayers;Processcontrolengineering;Services;Specification;Specification(approval);Transmissionmedia
【摘要】:1.1OverviewThefieldbusapplicationlayer(FAL)providesuserprogramswithameanstoaccessthefieldbuscommunicationenvironment.Inthisrespect,theFALcanbeviewedasa“windowbetweencorrespondingapplicationprograms.”ThispartofIEC61158providescommonelementsforbasictime-criticalandnon-time-criticalmessagingcommunicationsbetweenapplicationprogramsinanautomationenvironmentandmaterialspecifictoType18fieldbus.Theterm“time-critical”isusedtorepresentthepresenceofatime-window,withinwhichoneormorespecifiedactionsarerequiredtobecompletedwithsomedefinedlevelofcertainty.Failuretocompletespecifiedactionswithinthetimewindowrisksfailureoftheapplicationsrequestingtheactions,withattendantrisktoequipment,plantandpossiblyhumanlife.1.2SpecificationsTheprincipalobjectiveofthispartofIEC61158istospecifythecharacteristicsofconceptualapplicationlayerservicessuitablefortime-criticalcommunications,andthussupplementtheOSIBasicReferenceModelinguidingthedevelopmentofapplicationlayerprotocolsfortimecriticalcommunications.Asecondaryobjectiveistoprovidemigrationpathsfrompreviously-existingindustrialcommunicationsprotocols.ItisthislatterobjectivewhichgivesrisetothediversityofservicesstandardizedasthevariousTypesofIEC61158,andthecorrespondingprotocolsstandardizedinsubpartsofIEC61158-6.ThisspecificationmaybeusedasthebasisforformalApplicationProgramming-Interfaces.Nevertheless,itisnotaformalprogramminginterface,andanysuchinterfacewillneedtoaddressimplementationissuesnotcoveredbythisspecification,includinga)thesizesandoctetorderingofvariousmulti-octetserviceparameters,andb)thecorrelationofpairedrequestandconfirm,orindicationandresponse,primitives.1.3ConformanceThispartofIEC61158doesnotspecifyindividualimplementationsorproducts,nordotheyconstraintheimplementationsofapplicationlayerentitieswithinindustrialautomationsystems.Thereisnoconformanceofequipmenttothisapplicationlayerservicedefinitionstandard.Instead,conformanceisachievedthroughimplementationofconformingapplicationlayerprotocolsthatfulfilltheType18applicationlayerservicesasdefinedinthispartofIEC61158.
【中国标准分类号】:N18;P76
【国际标准分类号】:25_040_40;35_100_70;35_160
【页数】:42P;A4
【正文语种】:英语