EN ISO 15378-2011 药品的主要包装材料.以良好加工实践(GMP)为参考ISO9001-2008应用的特殊要求

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【英文标准名称】:Primarypackagingmaterialsformedicinalproducts-ParticularrequirementsfortheapplicationofISO9001:2008,withreferencetoGoodManufacturingPractice(GMP)(ISO15378:2011);GermanversionENISO15378:2011
【原文标准名称】:药品的主要包装材料.以良好加工实践(GMP)为参考ISO9001-2008应用的特殊要求
【标准号】:ENISO15378-2011
【标准状态】:现行
【国别】:
【发布日期】:2012-02-01
【实施或试行日期】:
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Accidentprevention;Definitions;Drugs;Expendablepackings;Industrialprocessmeasurement;Lock-up;Manufacturing;Medicalproducts;Medicaments;Non-reclosable;Packages;Packaging;Pharmaceuticpackages;Pharmacy;Productiontechniques;Purchasing;Qualificationtests;Quality;Qualityassurance;Qualitymanagement;Qualityrequirements;Safety;Safetyrequirements;Specification(approval);Surveillance(approval);Testing;Testingconditions
【摘要】:
【中国标准分类号】:C08
【国际标准分类号】:03_120_10;11_120_10;55_040
【页数】:80P;A4
【正文语种】:英语


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【英文标准名称】:Industrialcommunicationnetworks-Profiles-Part3-1:Functionalsafetyfieldbuses-AdditionalspecificationsforCPF1(IEC61784-3-1:2007);EnglishversionEN61784-3-1:2008
【原文标准名称】:工业通信网络.轮廓.第3-1部分:功能安全现场总线.CPF1用附加规范
【标准号】:DINEN61784-3-1-2008
【标准状态】:作废
【国别】:德国
【发布日期】:2008-11
【实施或试行日期】:2008-11-01
【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;自动化;总线系统;总线;电路网络;通信;控制设备;控制系统;控制工艺学;数据通信;数据链层;数据处理;数据服务;数据传送;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);IT安全;制造;开放系统互连;OSI;物理层;过程控制;过程控制工程;工艺工程;加工工程;轮廓;反作用;响应;规范;规范(验收);传输媒质
【英文主题词】:Applicationlayer;Automation;Bussystems;Buses(dataprocessing);Circuitnetworks;Communication;Controlequipment;Controlsystems;Controltechnology;Datacommunication;Datalinklayers;Dataprocessing;Dataservices;Datatransfer;Definition;Definitions;Digital;Digitaldata;Digitalengineering;EDP;Electricalengineering;Electronicinstruments;Electronicsystems;Englishlanguage;Fieldbus;Guidancesystems;Industrial;Industrialfacilities;Informationinterchange;Informationprocessing;Informationtechnology;Interfaces(dataprocessing);ITsecurity;Manufacturing;Opensystemsinterconnection;OSI;Physicallayers;Processcontrol;Processcontrolengineering;Processengineering;Productionengineering;Profile;Reaction;Response;Specification;Specification(approval);Transmissionmedia
【摘要】:ThispartoftheIEC61784-3seriesspecifiesasafetycommunicationlayer(servicesandprotocol)basedonCPF1ofIEC61784-1andIEC61158Type1and9.ItidentifiestheprinciplesforfunctionalsafetycommunicationsdefinedinIEC61784-3thatarerelevantforthissafetycommunicationlayer.NOTE1Itdoesnotcoverelectricalsafetyandintrinsicsafetyaspects.Electricalsafetyrelatestohazardssuchaselectricalshock.Intrinsicsafetyrelatestohazardsassociatedwithpotentiallyexplosiveatmospheres.Thispart1definesmechanismsforthetransmissionofsafety-relevantmessagesamongparticipantswithinadistributednetworkusingfieldbustechnologyinaccordancewiththerequirementsofIEC61508seriesforfunctionalsafety.Thesemechanismsmaybeusedinvariousindustrialapplicationssuchasprocesscontrol,manufacturingautomationandmachinery.Thispartprovidesguidelinesforbothdevelopersandassessorsofcompliantdevicesandsystems.NOTE2TheresultingSILclaimofasystemdependsontheimplementationoftheselectedfunctionalsafetycommunicationprofilewithinthissystem-implementationofafunctionalsafetycommunicationprofileaccordingtothispartinastandarddeviceisnotsufficienttoqualifyitasasafetydevice.
【中国标准分类号】:L67
【国际标准分类号】:35_160;35_240_50
【页数】:71P.;A4
【正文语种】:英语


【英文标准名称】:Earth-movingmachinery-Accesssystems(ISO2867:2011);GermanversionENISO2867:2011
【原文标准名称】:土方机械.通道装置(ISO2867-2011);德文版本ENISO2867-2011
【标准号】:ENISO2867-2011
【标准状态】:现行
【国别】:
【发布日期】:2011-11
【实施或试行日期】:
【发布单位】:欧洲标准学会(EN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Access;Accessfittings;Accessopenings;Accessibility;Accidentprevention;Buildingmachines;Catwalks;Climbingdevices;Definitions;Design;Dimensions;Earth-movingequipment;Enclosures;Ergonomics;Floors;Footsteps;Gangways;Gangways(buildings);Handles;Hand-rails;Ladders;Layout;Mechanicalengineering;Occupationalsafety;Openings;Operatingstations;Parapets;Ports(openings);Railings;Riskofstumbling;Rooms;Safetydesign;Safetydevices;Safetyengineering;Safetyofmachinery;Specification(approval);Specifications;Stairsteps;Stairs;Steps;Supportingstrap;Walkways;Workingplaces;Workplacesafety
【摘要】:
【中国标准分类号】:P97
【国际标准分类号】:53_100
【页数】:30P;A4
【正文语种】:英语