基本信息
标准名称: | C850系列酚醛棉布层压板 |
英文名称: | C850 system phenolic resins cotton cloth laminated sheets |
中标分类: |
电工 >>
电工材料和通用零件 >>
电工绝缘材料及其制品 |
ICS分类: |
电气工程 >>
绝缘材料 >>
其他绝缘材料
|
发布部门: | 中国电器工业协会 |
发布日期: | 2009-06-10 |
实施日期: | 2009-12-01 |
首发日期: | 2009-06-10 |
作废日期: | |
主管部门: | 中国电器工业协会 |
归口单位: | 全国绝缘材料标准化技术委员会 |
起草单位: | 全国绝缘材料标准化技术委员会(SAC/TC 51) |
出版社: | 中国标准出版社 |
出版日期: | 2009-12-01 |
页数: | 12页 |
计划单号: | 20077012-T-604 |
适用范围
本部分规定了电气绝缘用C850系列酚醛棉布层压板的分类、要求、试验方法和供货要求。本部分适用于电气绝缘用C850系列酚醛棉布层压板。
前言
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目录
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引用标准
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所属分类: 电工 电工材料和通用零件 电工绝缘材料及其制品 电气工程 绝缘材料 其他绝缘材料
【英文标准名称】:Medicaldevices-Qualitymanagementsystems-Requirementsforregulatorypurposes(ISO13485:2003);GermanversionENISO13485:2003+AC:2007
【原文标准名称】:医疗装置.质量管理体系.调整要求
【标准号】:DINENISO13485-2007
【标准状态】:作废
【国别】:德国
【发布日期】:2007-10
【实施或试行日期】:
【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】:售后服务;应用;CE标记;消费者与供货者的关系;定义;交付;交货条件;设计;详细规范;开发;文献;电气工程;架设(施工作业);手册;工业;检验;装配;装置;安装;仪器;国际标准;维修;医疗设备;医疗器械;医疗产品;医学科学;组织;工艺管理;采办;产品设计;生产计划;生产;质量;质量评定系统;质量保证;质量保证体系;质量检查;质量控制;质量改进;质量管理;质量要求;卖货商;服务设施;规范;规范(验收);标准;使用;验证
【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;Qualitymanagement;Qualityrequirements;Responsibility;Returncurrent;Sellers;Services;Shipping;Specification;Specification(approval);Standards;Steeringgear;Storage;Surveillance(approval);Testing;Training;Treatment;Use;Verification
【摘要】:1.1GeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovidemedicaldevicesandrelatedservicesthatconsistentlymeetcustomerrequirementsandregulatoryrequirementsapplicabletomedicaldevicesandrelatedservices.TheprimaryobjectiveofthisInternationalStandardistofacilitateharmonizedmedicaldeviceregulatoryrequirementsforqualitymanagementsystems.Asaresult,itincludessomeparticularrequirementsformedicaldevicesandexcludessomeoftherequirementsofISO9001thatarenotappropriateasregulatoryrequirements.Becauseoftheseexclusions,organizationswhosequalitymanagementsystemsconformtothisInternationalStandardcannotclaimconformitytoISO9001unlesstheirqualitymanagementsystemsconformtoalitherequirementsofISO9001(seeAnnexB).1.2ApplicationAllrequirementsofthisInternationalStandardarespecifictoorganizationsprovidingmedicaldevices,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】:03_120_10;11_040_01
【页数】:69P.;A4
【正文语种】:德语