NF S95-111-1-2005 麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套
作者:标准资料网 时间:2024-05-17 10:56:01 浏览:8083
来源:标准资料网
下载地址: 点击此处下载
【英文标准名称】:Anaestheticandrespiratoryequipment-Conicalconnectors-Part1:conesandsockets.
【原文标准名称】:麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套
【标准号】:NFS95-111-1-2005
【标准状态】:现行
【国别】:法国
【发布日期】:2005-03-01
【实施或试行日期】:2005-03-20
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:25P;A4
【正文语种】:其他
【原文标准名称】:麻醉和呼吸设备.锥形接头.第1部分:锥体和锥套
【标准号】:NFS95-111-1-2005
【标准状态】:现行
【国别】:法国
【发布日期】:2005-03-01
【实施或试行日期】:2005-03-20
【发布单位】:法国标准化协会(AFNOR)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:
【摘要】:
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:25P;A4
【正文语种】:其他
下载地址: 点击此处下载
上一篇: NF V08-411-2005 食品和动物饲料的微生物学.志贺氏杆菌检测的水平法
下一篇: NF C74-155-2005 医用成像部门的评价及例行试验.第3-5部分:验收试验.计算机断层摄影X射线设备的成像性能
下一篇: NF C74-155-2005 医用成像部门的评价及例行试验.第3-5部分:验收试验.计算机断层摄影X射线设备的成像性能
【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes
【原文标准名称】:医疗器械.质量管理系统.管理目标的要求
【标准号】:ISO13485-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:回流;检验;服务设施;工艺管理;手册;质量;架设(施工作业);维修;医疗设备;标准;医疗器械;医疗器械;工业;国际标准;详细规范;卖货商;医疗产品;售后服务;开发;仪器;CE标记;验证;生产;医学科学;质量保证体系;消费者与供货者的关系;采办;装置;设计;装配;文献工作;交货条件;应用;规范;规范(验收);定义;电气工程;质量检查;使用;质量评定系统;质量保证;质量要求;交付
【英文主题词】:After-salesservices;Applications;Auditing;Bearings;CEmarking;Conduits;Consumer-supplierrelations;Corrrections;Customers;Data;Definitions;Delivery;Deliveryconditions;Design;Detailspecification;Developments;Documentations;Editing;Electricalengineering;Erecting(constructionoperation);Establishment;Evaluations;Handbooks;Handling;Industries;Inspection;Installation;Installations;Instruments;Internationalstandards;Maintenance;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Organization;Packages;Planning;Preservation;Preventiveactions;Process;Processmanagement;Procurements;Productdesign;Productplanning;Production;Products;Quality;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityauditing;Qualitycontrol;Qualityimprovement;Qualityrequirements;Responsibility;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalltherequirementsofISO9001(seeAnnexB).2ApplicationAllrequirementsofthisInternationalStandardarespecifictoorganizationsprovidingmedicaldevices,regardlessofthetypeorsizeoftheorganization.Ifregulatoryrequirementspermitexclusionsofdesignanddevelopmentcontrols(see7.3),thiscanbeusedasajustificationfortheirexclusionfromthequalitymanagementsystem.Theseregulationscanprovidealternativearrangementsthataretobeaddressedinthequalitymanagementsystem.ItistheresponsibilityoftheorganizationtoensurethatclaimsofconformitywiththisInternationalStandardreflectexclusionofdesignanddevelopmentcontrols[see4.2.2a)and7.3].Ifanyrequirement(s)inClause7ofthisInternationalStandardis(are)notapplicableduetothenatureofthemedicaldevice(s)forwhichthequalitymanagementsystemisapplied,theorganizationdoesnotneedtoincludesucharequirement(s)initsqualitymanagementsystem[see4.2.2a)].TheprocessesrequiredbythisInternationalStandard,whichareapplicabletothemedicaldevice(s),butwhicharenotperformedbytheorganization,aretheresponsibilityoftheorganizationandareaccountedforintheorganization'squalitymanagementsystem[see4.1a)].InthisInternationalStandardtheterms"ifappropriate"and"whereappropriate"areusedseveraltimes.Whenarequirementisqualifiedbyeitherofthesephrases,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.Arequirementisconsidered"appropriate"ifitisnecessaryinorderfor—theproducttomeetspecifiedrequirements,and/or—theorganizationtocarryoutcorrectiveaction.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:57P;A4
【正文语种】:英语
【英文标准名称】:TerrestrialTrunkedRadio(TETRA)-VoiceplusData(V+D)-Part12:Supplementaryservicesstage3;Sub-part19:BarringofIncomingCalls(BIC)(EndorsementoftheEnglishversionEN300392-12-19V1.1.1(2001-08)asGermanstandard)
【原文标准名称】:地面无线中继线路(TETRA).声音加数据(V+D).第12部分:补充业务阶段3.第19分部分:非来话呼叫(BIC)
【标准号】:DINEN300392-12-19-2003
【标准状态】:现行
【国别】:德国
【发布日期】:2003-04
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:跨欧洲集群无线;数据传送;远程通信;电信;服务设施;地面无线中继线路;无线电工程;无线电广播网;夹持;无线电设备;化合物;规范(验收);无线通信业务;语音传输
【英文主题词】:Compound;Datatransfer;Holding;Radioengineering;Radioequipment;Radionetworks;Services;Specification(approval);Speechtransmission;Telecommunication;Telecommunications;TETRA;Transeuropeantrunked
【摘要】:ThisEuropeanstandardspecifiesrequirementsinthetelecommunicationssector.
【中国标准分类号】:M31
【国际标准分类号】:33_070_10
【页数】:1P;A4
【正文语种】:德语
【原文标准名称】:医疗器械.质量管理系统.管理目标的要求
【标准号】:ISO13485-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC210
【标准类型】:()
【标准水平】:()
【中文主题词】:回流;检验;服务设施;工艺管理;手册;质量;架设(施工作业);维修;医疗设备;标准;医疗器械;医疗器械;工业;国际标准;详细规范;卖货商;医疗产品;售后服务;开发;仪器;CE标记;验证;生产;医学科学;质量保证体系;消费者与供货者的关系;采办;装置;设计;装配;文献工作;交货条件;应用;规范;规范(验收);定义;电气工程;质量检查;使用;质量评定系统;质量保证;质量要求;交付
【英文主题词】:After-salesservices;Applications;Auditing;Bearings;CEmarking;Conduits;Consumer-supplierrelations;Corrrections;Customers;Data;Definitions;Delivery;Deliveryconditions;Design;Detailspecification;Developments;Documentations;Editing;Electricalengineering;Erecting(constructionoperation);Establishment;Evaluations;Handbooks;Handling;Industries;Inspection;Installation;Installations;Instruments;Internationalstandards;Maintenance;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalproducts;Medicalsciences;Methods;Organization;Packages;Planning;Preservation;Preventiveactions;Process;Processmanagement;Procurements;Productdesign;Productplanning;Production;Products;Quality;Qualityassessmentsystems;Qualityassurance;Qualityassurancesystems;Qualityauditing;Qualitycontrol;Qualityimprovement;Qualityrequirements;Responsibility;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalltherequirementsofISO9001(seeAnnexB).2ApplicationAllrequirementsofthisInternationalStandardarespecifictoorganizationsprovidingmedicaldevices,regardlessofthetypeorsizeoftheorganization.Ifregulatoryrequirementspermitexclusionsofdesignanddevelopmentcontrols(see7.3),thiscanbeusedasajustificationfortheirexclusionfromthequalitymanagementsystem.Theseregulationscanprovidealternativearrangementsthataretobeaddressedinthequalitymanagementsystem.ItistheresponsibilityoftheorganizationtoensurethatclaimsofconformitywiththisInternationalStandardreflectexclusionofdesignanddevelopmentcontrols[see4.2.2a)and7.3].Ifanyrequirement(s)inClause7ofthisInternationalStandardis(are)notapplicableduetothenatureofthemedicaldevice(s)forwhichthequalitymanagementsystemisapplied,theorganizationdoesnotneedtoincludesucharequirement(s)initsqualitymanagementsystem[see4.2.2a)].TheprocessesrequiredbythisInternationalStandard,whichareapplicabletothemedicaldevice(s),butwhicharenotperformedbytheorganization,aretheresponsibilityoftheorganizationandareaccountedforintheorganization'squalitymanagementsystem[see4.1a)].InthisInternationalStandardtheterms"ifappropriate"and"whereappropriate"areusedseveraltimes.Whenarequirementisqualifiedbyeitherofthesephrases,itisdeemedtobe"appropriate"unlesstheorganizationcandocumentajustificationotherwise.Arequirementisconsidered"appropriate"ifitisnecessaryinorderfor—theproducttomeetspecifiedrequirements,and/or—theorganizationtocarryoutcorrectiveaction.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:57P;A4
【正文语种】:英语
【英文标准名称】:TerrestrialTrunkedRadio(TETRA)-VoiceplusData(V+D)-Part12:Supplementaryservicesstage3;Sub-part19:BarringofIncomingCalls(BIC)(EndorsementoftheEnglishversionEN300392-12-19V1.1.1(2001-08)asGermanstandard)
【原文标准名称】:地面无线中继线路(TETRA).声音加数据(V+D).第12部分:补充业务阶段3.第19分部分:非来话呼叫(BIC)
【标准号】:DINEN300392-12-19-2003
【标准状态】:现行
【国别】:德国
【发布日期】:2003-04
【实施或试行日期】:
【发布单位】:德国标准化学会(DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:跨欧洲集群无线;数据传送;远程通信;电信;服务设施;地面无线中继线路;无线电工程;无线电广播网;夹持;无线电设备;化合物;规范(验收);无线通信业务;语音传输
【英文主题词】:Compound;Datatransfer;Holding;Radioengineering;Radioequipment;Radionetworks;Services;Specification(approval);Speechtransmission;Telecommunication;Telecommunications;TETRA;Transeuropeantrunked
【摘要】:ThisEuropeanstandardspecifiesrequirementsinthetelecommunicationssector.
【中国标准分类号】:M31
【国际标准分类号】:33_070_10
【页数】:1P;A4
【正文语种】:德语