14644-1:2015(E)
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ISO 14644-1
Cleanrooms 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
2015-12-15
Contents 目录
Foreword 前言
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International 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 reprented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates cloly 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。
The procedures ud to develop this document and tho 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 document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (e www.iso/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www.iso/directives）。
Attention is drawn to the possibility that some of 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 declarations received (e www.iso/patents).
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www.iso/patents）。西班牙语翻译公司
Any trade name ud in this document is information given for the convenience of urs and does not constitute an endorment.
penang hill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。
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For an explanation on the meaning of ISO specific terms and expressions related to conformity asssment, as well as i nformation about ISO’s adhe rence to the WTO principles in the Technical Barriers to Trade (TBT) e the following URL: Foreword - Supplementary information
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。
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.
委员会负责的文件是ISO/TC 209，洁净室和相关的控制环境。
This cond edition cancels and replaces the first edition (ISO 14644-1:1999), which has been technically revid throughout.
该第二版取消并代替了第一版(ISO 14644-1:1999)，在技术上进行了彻底的修改。
新年快乐用英语怎么说ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:
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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度分级
—Part 2: Monitoring to provide evidence of cleanroom 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 devices (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)灰姑娘剧本
—第八部分：基于化学浓度的空气洁净分级（ACC）
preference—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: 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ISO 14698，洁净室和相关受控环境----微生物污染控制：
—Part 1: General principles and methods
—第一部分：总则和方法
—Part 2: Evaluation and interpretation of biocontamination data
—第二部分：微生物污染数据评价和解释
Introduction 介绍
gathererCleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-nsitive activities. Contamination 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，表面，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、医疗保健和食品行业。
This part of ISO 14644 specifies class of air cleanliness in terms of the number of particles expresd as a concentration in air volume. It also specifies the standard method of testing to determine cleanliness class, including lection of sampling locations.
ISO 14644的该部分说明将空气洁净级别为单位空气体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。英文话剧剧本
beijing travelThis edition is the result of a respon to an ISO Systematic Review and includes changes in respon to ur and expert feedback validated by international enquiry. The title has been revid t o “Classification of a ir cleanliness by particle concentr ation” to be consistent with other parts of ISO 14644. The nine ISO cleanliness class are retained with minor revisions. Table
1 defines the particle concentration at various particle sizes for the nine integer class. Table
E.1 defines the maximum particle concentration at various particle sizes for intermediate class. The u of the tables ensures better definition of the appropriate particle-size ranges for the different class. This part of ISO 14644 retains the macroparticle descriptor concept; however, consideration of nano-scale particles (formerly defined as ultrafine particles) will be addresd in a parate 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ISO 14644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子浓度。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围的更好定义。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 change is the adoption of a more consistent statistical approach to the lection and the number of sampling locations; and the evaluation of the data collected. The statistical model is bad on adaptation of the hypergeometric sampling model technique, where samples are drawn randomly without replacement 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 assumptions 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 allow the sampling to be ud 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 been
