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14644-1:2015(E)1/58ISO14644-1Cleanroomsandassociatedcontrolledenvironments洁净室和相关的受控环境Part1:第一部分:Classificationofaircleanlinessbyparticleconcentration通过粒子浓度对空气洁净度进行分级第二版本2015-12-1514644-1:2015(E)2/58Contents目录Foreword前言Introduction介绍1Scope范围2Normativereferences标准参考3Termsanddefinitions.术语和定义3.1General概述3.2Airborneparticles空气悬浮粒子3.3Occupancystates使用状态3.4Testinginstrumentation(seeAnnexF)测试仪器（参见附录E）3.5Instrumentspecifications仪器规格4Classification级别4.1Occupancystate(s)使用状态4.2Particlesize(s)粒径4.3ISOClassnumberISO级别编号4.4Designation.名称指定4.5Intermediatedecimalcleanlinessclassesandparticlesizethresholds中间洁净级别和粒径阈值5Demonstrationofcompliance符合性证明5.1Principle原则5.2Testing测试5.3Airborneparticleconcentrationevaluation空气悬浮粒子浓度评估5.4Testreport.测试报告AnnexA(normative)Referencemethodforclassificationofaircleanlinessbyparticleconcentration附录A（标准文件）采用粒子浓度对空气洁净度分级的参考方法AnnexB(informative)Examplesofclassificationcalculations附录B（仅供参考）分级计数举例AnnexC(informative)Countingandsizingofairbornemacroparticles附录C（仅供参考）空气大粒子计数和粒径测量AnnexD(informative)Sequentialsamplingprocedure附录D（仅供参考）顺序取样法AnnexE(informative)Specificationofintermediatedecimalcleanlinessclassesandparticlesizethresholds附录E（仅供参考）中间洁净级别和粒径阈值标准AnnexF(informative)Testinstruments附录F（仅供参考）测试仪器Bibliography文献14644-1:2015(E)3/58Foreword前言ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.ISO（国际标准化组织）为全球各国标准化团体的联合会（ISO会员团体）。其国际标准工作一般是由ISO各技术委员会执行。每个会员团体若对技术委员会的某一课题感兴趣，均有权作为此技术委员会的代表。任何与ISO保持联系的国际组织，无论是政府的还是非政府的组织，同样可参加此项工作。ISO与国际电气技术委员会（IEC）在电气技术标准化方面进行紧密合作。TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see).该程序用来开发本文件并且意图对其进一步的维护，这些在ISO/IEC指示的第一部分有所描述。尤其是应注意不同的审批标准所需的不同类型的ISO文件。该文件是按照ISO/IEC第二部分的编辑规则进行起草（参见）。Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see).该文件的某些元素可能被吸引注意的可能是一些专利权的主题。ISO对识别任何或所有这样的专利权不负有责任。专利权的确认细节在文件开发阶段将会在介绍和/或ISO收到的专利声明列表中说明。（参见）。Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.本文件中使用的任何商标名称是为了方便用户，不构成认可。ForanexplanationonthemeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO’sadherencetotheWTOprinciplesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:Foreword-Supplementaryinformation为了解释ISO特定术语的意思以及说明相关符合性评估，以及ISO和WTO原则在技术性贸易壁垒（TBT）方面的联系可参见下面的URL：前言的补充信息。ThecommitteeresponsibleforthisdocumentisISO/TC209,Cleanroomsandassociatedcontrolledenvironments.委员会负责的文件是ISO/TC209，洁净室和相关的控制环境。Thissecondeditioncancelsandreplacesthefirstedition(ISO14644-1:1999),whichhasbeentechnicallyrevisedthroughout.该第二版取消并代替了第一版(ISO14644-1:1999)，在技术上进行了彻底的修改。14644-1:2015(E)4/58ISO14644consistsofthefollowingparts,underthegeneraltitleCleanroomsandassociatedcontrolledenvironments:ISO14644由下面部分组成，在大标题洁净室和相关受控环境之下：—Part1:Classificationofaircleanlinessbyparticleconcentration—第一部分：根据粒子浓度对空气洁净度分级—Part2:Monitoringtoprovideevidenceofcleanroomperformancerelatedtoaircleanlinessbyparticleconcentration—第二部分：通过监控对和洁净室性能相关的以粒子浓度对空气洁净度分级的证据—Part3:Testmethods—第三部分：测试方法—Part4:Design,constructionandstart-up—第四部分：设计、施工和启动—Part5:Operations—第五部分：操作—Part7:Separativedevices(cleanairhoods,gloveboxes,isolatorsandmini-environments)—第七部分：单独装置（清洁空气容器、手套箱、隔离器和mini-环境）—Part8:Classificationofaircleanlinessbychemicalconcentration(ACC)—第八部分：基于化学浓度的空气洁净分级（ACC）—Part9:Classificationofsurfacecleanlinessbyparticleconcentration—第九部分：基于粒子浓度的表面清洁分类—Part10:Classificationofsurfacecleanlinessbychemicalconcentration—第十部分：基于化学浓度的表面清洁分类AttentionisalsodrawntoISO14698,Cleanroomsandassociatedcontrolledenvironments—Biocontaminationcontrol:同样受到关注的还有ISO14698，洁净室和相关受控环境----微生物污染控制：—Part1:Generalprinciplesandmethods—第一部分：总则和方法—Part2:Evaluationandinterpretationofbiocontaminationdata—第二部分：微生物污染数据评价和解释14644-1:2015(E)5/58Introduction介绍Cleanroomsandassociatedcontrolledenvironmentsprovideforthecontrolofcontaminationofairand,ifappropriate,surfaces,tolevelsappropriateforaccomplishingcontamination-sensitiveactivities.Contaminationcontrolcanbebeneficialforprotectionofproductorprocessintegrityinapplication