ISO 14644-1：2015 洁净室及相关控制环境国际标准_中英对照.docx

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1、14644-1:2015(E)ISO 14644-1Cleanrooms and associated controlled environments洁净室和相关的受控环境Part 1:第一部分：Classification of air cleanliness by particle concentration通过粒子浓度对空气洁净度进行分级第二版本2015-12-15Contents 目录Foreword前言Introduction介绍1Scope范围2Normative references标准参考3Terms and definitions.术语和定义3.1 General概述3.2

2、Airborne particles空气悬浮粒子3.3 Occupancy states使用状态3.4 Testing instrumentation (see Annex F)测试仪器（参见附录E）3.5 Instrument specifications仪器规格4Classification级别4.1 Occupancy state(s)使用状态4.2 Particle size(s)粒径4.3 ISO Class numberISo级别编号4.4 Designation.名称指定4.5 Intermediate decimal cleanliness classes and partic

3、le size thresholds中间洁净级别和粒径阈值5Demonstration of compliance符合性证明5.1 Principle原则5.2 Testing测试5.3 Airborne particle concentration evaluation空气悬浮粒子浓度评估5.4 Test report测试报告Annex A (normative) Reference method for classification of air cleanliness by particle concentration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Anne

4、x B (informative) Examples of classification calculations附录B （仅供参考）分级计数举例Annex C (informative) Counting and sizing of airborne macroparticles附录C （仅供参考）空气大粒子计数和粒径 测量Annex D (informative) Sequential sampling procedure附录D （仅供参考）顺序取样法Annex E (informative) Specification of intermediate decimal cleanlines

5、s classes and particle size thresholds附录E （仅供参考）中间洁净级别和粒径阈值标准Annex F (informative) Test instruments附录F （仅供参考）测试仪器Bibliography文献Foreword 前言ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Interna

6、tional Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with

7、ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.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各技术委员公执行。每个会员团体若对技术委员公的某一课题感兴趣，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

8、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。The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This d

9、ocument was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 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ISe)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WWW.iso.org/directives)。Attention is drawn to the possibility that some of

10、 the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declaration

11、s received (see www.iso.org/patents).该文件的某些元素可能被吸弓I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WWW.iso.org/PatentS) Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.本文件中使用的任何商标名称是为了方便用户，

12、不构成认可。For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information 为了解糕ISo特定术语的意思以及说明相关符

13、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。The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.委员会负责的文件是ISozTC 209.洁净宝和相关的控制环境。This second edition cancels and replaces the first edition (ISO 14644-1:1999), which has been technically

14、revised throughout.该第二版取消并代替了第版(ISo 14644-1:1999),在技术上进行了彻底的修改。ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:ISO 14644由下面部分组成，在大标题洁净室和相关受控环境之下： Part 1: Classification of air cleanliness by particle concentration- 第一部分：根据粒子浓度对空气洁净

15、度分级 Part 2: Monitoring to provide evidence of cileanroom performance related to air cleanliness by particle concentration- 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 Part 3: Test methods- 第三部分:测试方法 Part 4: Design, construction and start-up- 第四部分：设计、施工和启动 Part 5: Operations- 第五部分：操作 Part 7: Separative devic

16、es (clean air hoods, gloveboxes, isolators and mini-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) Part 8: Classification of air cleanliness by chemical concentration (ACC)- 第八部分：基于化学浓度的空气洁净分级( ACC) Part 9: Classification of surface cleanliness by particle concentration- 第九部分：基于粒子浓度的表面清洁分类 Part 10

17、: Classification of surface cleanliness by chemical concentration- 第十部分：基于化学浓度的表面清洁分类Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments Biocontamination control:同样受到关注的还有ISe) 14698.洁净室和相关受控环境微生物污染控制：- Part 1: General principles and methods- 第部分：总则和方法- Part 2: Eva

18、luation and interpretation of biocontamination data- 第二部分：微生物污染数据评价和解释5/58Introduction 介绍Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contam

19、ination control can be beneficial for protection of product or process integrity in applications in industries such as aerospace, microelectronics, pharmaceuticals, medical devices, healthcare and food.洁净室和相关的受控环境提供空气污染物的控制，和，如果使用，去面，来完成对污染敏感的活动 提供适当的水平。污染控制对保护产品或在工艺中保持工艺完整是有益的，比如航空航天、微电子 学、制药、医疗设备、

20、医疗保健和食品行业。This part of ISO 14644 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume. It also specifies the standard method of testing to determine cleanliness class, including selection Of sampling locations.ISoI4644的该部分说明将空气洁净级别为单位空气体

21、积的浓度用粒子数量进行表述。它也同样说 明了确定洁净级别测试方法的标准，包括选择取样位置。This edition is the result of a response to an ISO Systematic Review and includes changes in response to user and expert feedback validated by international enquiry. The title has been revised to Classification of air cleanliness by particle concentration

22、 to be consistent with other parts of ISO 14644. The nine ISO cleanliness classes are retained with minor revisions. Table 1 defines the particle concentration at various particle sizes for the nine integer classes. Table E.1 defines the maximum particle concentration at various particle sizes for i

23、ntermediate classes. The use of these tables ensures better definition of the appropriate particle-size ranges for the different classes. This part of ISO 14644 retains the macroparticle descriptor concept; however, consideration of nano-scale particles (formerly defined as ultrafine particles) will

24、 be addressed in a separate standard.该版本是对ISo系统回顾响应的结果并包含使用者和专家经过国际咨询后的经过验证的变化。标题 已经改为“通过粒子浓度对空气洁净度的分级来和其他ISOI4644部分保持一致。9个ISo洁净级别 经过小幅修改得以保留。表1针对9个级别定义了不同粒径的粒了浓度。表E.1定义了在不同等级不 同大小的粒子的最大浓度。该表格的使用确保了针对不同等级下适当粒子范困的更好定义。ISO 14644的这部分保留了大粒子描述内容；可是，对纳米范围粒子(以前定义为超细微粒子)的考虑 将会在单独的标准中给出。The most significant

25、change is the adoption of a more consistent statistical approach to the selection and the number of sampling locations; and the evaluation of the data collected. The statistical model is based on adaptation of the hypergeometric sampling model technique, where samples are drawn randomly without repl

26、acement from a finite population. The new approach allows each location to be treated independently with at least a 95 % level of confidence that at least 90 % of the cleanroom or clean zone areas will comply with the maximum particle concentration limit for the target class of air cleanliness. No a

27、ssumptions are made regarding the distribution of the actual particle counts over the area of the cleanroom or clean zone; while in ISO 14644-1:1999 an underlying assumption was that the particle counts follow the same normal distribution across the room, this assumption has now been discarded to al

28、low the sampling to be used in rooms where the particle counts vary in a more complex manner. In the process of revision it has been recognized that the 95 % UCL was neither appropriate nor was applied consistently in ISO 14644-1:1999. The minimum number of sampling locations required has beenchange

29、d, compared with ISO 14644-1:1999. A reference table, Table A.1, is provided to define the minimum number of sampling locations required based on a practical adaptation of the sampling model technique. An assumption is made that the area immediately surrounding each sampling location has a homogeneo

30、us particle concentration. The cleanroom or clean zone area is divided up into a grid of sections of near equal area, whose number is equal to the number of sampling locations derived from Table A.1. A sampling location is placed within each grid section, so as to be representative of that grid sect

31、ion.最重要的变化是采用更致的统计方法来选择取样位置和取样数量：并对选择的数据进行评价。统 计模型是基于超儿何抽样模型的适应性技术，从有限样本中随机抽取样品。新的方法允许每个位置 可独立处理并在95%置信区间水平，至少90%的洁净室或洁净区将会符合目标洁净级别下最大粒子 浓度。没有针对实际分布在洁净室或洁净区的粒了进行假设：1999年版的ISol4644-1中个基本 的假设是粒子计数遵循相同的正态分布穿过房间，该假设Il前己经废除，允许以更加复杂的方式在 粒子数变化很大的房间进行取样。在ISo 14644-1 1999年版的修改过程中已经认识到95%的UCL 既不合适且应用也不一致。相对于I

32、Sol4644-1： 1999,最小数量的取样位置要求已经改变。个 参考表格，表A.1,已经在一个实际取样模型的适应性技术中进行提供，以定义需要的最小数量的 取样位置。假设在每个取样位置附近有均匀的粒子浓度。洁净室或洁净区域被分割为近乎均等的网 格区域，它的数量和根据表A.1推断的取样位置数量是相同的。个取样位置就放在一个网格部分， 以便代表该网格部分。It is assumed for practical purposes that the locations are chosen representatively; a representative location (see A.4.2)

33、 means that features such as cleanroom or clean zone layout, equipment disposition and air flow systems should be considered when selecting sampling locations. Additional sampling locations may be added to the minimum number of sampling locations.它是以实际目的来假定选择的位置是典型的:个典型的位置(见A.4.2)意味着特性，比如洁净 室或洁净区布局、

34、设备处置和气流系统在选择取样位置时应该考虑。针对最少取样数量的位置U以 增加额外的取样。Finally, the annexes have been reordered to improve the logic of this part of ISO 14644 and portions of the content of certain annexes concerning testing and test instruments have been included from ISO 14644-3:2005.最后，附录已经进行再排序以改善ISo 14644该部分的逻辑，该附录的部分内容关

35、于测试和测试仪 器已经包括在ISo 14644:2005版中。The revised version of this part of ISO 14644 addresses the 5 m particle limits for ISO Class 5 in the sterile products annexes of the EU, PIC/S and WHO GMPs by way of an adaptation of the macroparticle concept.修订的ISo 14644部分对N5pm粒径的粒子限度是按照ISO 5级，在EU无雨产品附录、PIC/S和WHo GM

36、P中当做大粒子的内容。The revised version of this part of ISO 14644 now includes all matters related to classification of air cleanliness by particle concentration. The revised version of ISO 14644-2:2015 now deals exclusively with the monitoring of air cleanliness by particle concentration.现在修订版本的ISoI4644部分包括

37、所有基于粒子浓度的相关空气洁净等级的事项。 2015年修订的 ISO 14644-2现在专门处理关于粒子浓度洁净等级的监测。Cleanrooms may also be characterized by attributes in addition to the classification of air cleanliness by particle concentration. Other attributes, such as air cleanliness in terms of14644-1:2015(E) chemical concentration, may be monitor

38、ed and the attributes grade or level may be designated along with the classification of the ISO Class of cleanliness. These additional attributes do not suffice alone to classify a cleanroom or clean zone.洁净室也可以具有除了基于粒子浓度的空气洁净度外的其他属性。其他的属性，如基于化学浓度的 空气洁净度，可能监测并且属性的等级或水平可能被制定为ISo洁净度级别。这些附加的属性并不 能单独对洁净

39、室或洁净区进行分级。7/5814644-1:2015(E)Cleanrooms and associated controlled environments洁净室和相关受控环境Part 1:Classification of air cleanliness by particle concentration第一部分：由粒子浓度确定的洁净度分级1 Scope范围This part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles

40、in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7.ISO 14644本部分规定了洁净室和洁净区、以及ISOl4644-7定义的隔离装置中的空气洁净度等级 是根据空气中悬浮粒子浓度来划分的。Only particle populations having cumulative distributions based on threshold (lower limit) particle sizes ranging from 0,1 m to 5 m are considered for

41、classification purposes.只有在0m-0.5m的阈值(低于阈值)粒径范围内呈累积分布的粒子群体才可供分级用。The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations.光散射(离散

42、)空气粒子计数器(LSAPC)的使用是确定晶浮粒子浓度的基础，在设计的取样点， 等丁和超过规定的粒径。This part of ISO 14644 does not provide for classification of particle populations that are outside the specified lower threshold particle-size range, 0,1 m to 5 m. Concentrations of ultrafine particles (particles smaller than 0,1 m) will be address

43、ed in a separate standard to specify air cleanliness by nano-scale particles. An M descriptor (see Annex C) may be used to quantify populations of macroparticles (particles larger than 5 m).ISoI4644本部分并不提供超出规定的低于阈值的粒径范围，即0.1m-5m粒子数的分级。超细粒 子浓度(小丁01m的粒子)将在纳米级颗粒专门的空气洁净度的单独标准中进行描述。一个M描 述符(见附录C)用于量化大颗粒群(

44、粒子超过5m)。This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, viable or other nature of airborne particles.ISc)14644本部分不能破用于表征物理、化学、放射性、生存性或其他空气粒子特性。2 Normative references 引用标准The following documents, in whole or in part, are normatively referenced in this docum

45、ent and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.以卜文件，整体或部分，在本文中被规范的参考并成为必要的应用。对于参考日期，仅引用的版本 适用。对无限期的参考文件，适用参考文件最新的版本(包含最新的修订)。ISO 14644-2:2015

46、, Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentrationISO14644-2： 2015洁净室和相关的受控环境第二部分：通过粒子浓度对空气洁净度行关的洁净 室性能提供证据的监测ISO 14644-7, Cleanrooms and associated controlled environments Part 7: S

47、eparative devices (clean air hoods, gloveboxes, isolators and mini-environments)ISO14644-7,洁净室和相关的受控环境一第七部分：隔离装置(洁净空气罩、手套箱、隔离器和 微型环境)3 Terms and definitions 3 术语和定义For the purposes of this document, the following terms and definitions apply.本文所用术语和定义描述如下。3.1 General 通贝 IJ3.1.1Cleanroom洁净室room within

48、 which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the room房间中悬浮粒子浓度的数量是受控的和有级别的，以某种方式对房间进行设计、建造和使用，以控 制室内粒子的引入、产生和滞留。Note 1 to entry: The class of airborne particle concentration is specified.注1：指定惹浮粒子浓度分级.Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also