1、BSI Standards PublicationBS EN ISO 14644-1:2015Cleanrooms and associatedcontrolled environmentsPart 1: Classification of air cleanliness byparticle concentrationBS EN ISO 14644-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 14644-1:2015.It supersedes
2、 BS EN ISO 14644-1:1999 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee LBI/30, Cleanroom technology.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the ne
3、cessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 57297 5ICS 13.040.35Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard wa
4、s published under the authority of theStandards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 14644-1 December 2015 ICS 13.040.35 Supersedes EN ISO 14644-1:1999English Version C
5、leanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) Salles propres et environnements matriss apparents - Partie 1: Classification de la propret particulaire de lair (ISO 14644-1:2015) Reinrume und zugehrige Reinrau
6、mbereiche - Teil 1: Klassifizierung der Luftreinheit anhand der Partikelkonzentration (ISO 14644-1:2015) This European Standard was approved by CEN on 27 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European S
7、tandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (Eng
8、lish, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,
9、 Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan
10、d, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Memb
11、ers. Ref. No. EN ISO 14644-1:2015 EBS EN ISO 14644-1:2015EN ISO 14644-1:2015 (E) 3 European foreword This document (EN ISO 14644-1:2015) has been prepared by Technical Committee ISO/TC 209“Cleanrooms and associated controlled environments“ in collaboration with Technical CommitteeCEN/TC 243 “Cleanro
12、om technology” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of anidentical text or by endorsement, at the latest by June 2016, and conflicting national standards shall bewithdrawn at the latest by June 2016. A
13、ttention is drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes EN ISO 14644-1:1999. According to the CEN-CENELEC Internal Regul
14、ations, the national standards organizations of thefollowing countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,France, Germany, Greece, Hungary, Iceland, Ireland, Italy
15、, Latvia, Lithuania, Luxembourg, Malta,Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,Turkey and the United Kingdom. Endorsement notice The text of ISO 14644-1:2015 has been approved by CEN as EN ISO 14644-1:2015 without anymodification. BS EN ISO 1464
16、4-1:2015ISO 14644-1:2015(E)Foreword ivIntroductionv1 Scope . 12 Normative references 13 Terms and definitions. 13.1 General . 13.2 Airborne particles 23.3 Occupancy states . 33.4 Testing instrumentation (see Annex F) . 33.5 Instrument specifications 44 Classification 44.1 Occupancy state(s) 44.2 Par
17、ticle size(s) . 44.3 ISO Class number 44.4 Designation 54.5 Intermediate decimal cleanliness classes and particle size thresholds . 55 Demonstration of compliance 65.1 Principle 65.2 Testing 65.3 Airborne particle concentration evaluation 6Annex5.4 Test report . 6A (normative) Reference method for c
18、lassification of air cleanliness by particle concentration 8Annex B (informative) Examples of classification calculations.13Annex C (informative) Counting and sizing of airborne macroparticles.22Annex D (informative) Sequential sampling procedure27Annex E (informative) Specification of intermediate
19、decimal cleanliness classes and particle size thresholds34Annex F (informative) Test instruments36Bibliography.37 ISO 2015 All rights reserved iiiContents PageBS EN ISO 14644-1:2015ISO 14644-1:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of nation
20、al 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 represented on that committee. Internatio
21、nal organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended
22、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 (see www.iso.
23、org/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 b
24、e in the Introduction and/or on the ISO list of patent declarations received (see 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.For an explanation on the meaning of ISO specific terms and expressions
25、 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 informationThe committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlledenvi
26、ronments.This second edition cancels and replaces the first edition (ISO 14644-1:1999), which has been technically revised throughout.ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlledenvironments: Part 1: Classification of air cleanliness by part
27、icle concentration Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particleconcentration Part 3: Test methods Part 4: Design, construction and start-up Part 5: Operations Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environ
28、ments) Part 8: Classification of air cleanliness by chemical concentration (ACC) Part 9: Classification of surface cleanliness by particle concentration Part 10: Classification of surface cleanliness by chemical concentrationAttention is also drawn to ISO 14698, Cleanrooms and associated controlled
29、environments Biocontamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of biocontamination dataiv ISO 2015 All rights reservedBS EN ISO 14644-1:2015ISO 14644-1:2015(E)IntroductionCleanrooms and associated controlled environments provide for the control of
30、 contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be beneficial for protection of product or process integrity in applications in industries such as aerospace, microelectronics, pharmaceuticals,
31、medical devices, healthcare and food.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.
32、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” to be consistent with other parts of ISO 1
33、4644. 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 intermediate classes. The use of these table
34、s 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 be addressed in a separate standard.The mo
35、st significant 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 random
36、ly 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 cl
37、eanliness. 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
38、discarded to allow 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
39、 has been changed, 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
40、 has a homogeneous 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 o
41、f that grid section.It is assumed for practical purposes that the locations are chosen representatively; a “representative” location (see A.4.2) means that features such as cleanroom or clean zone layout, equipment disposition and airflow systems should be considered when selecting sampling location
42、s. Additional sampling locations may be added to the minimum number of sampling locations.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
43、:2005.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.The revised version of this part of ISO 14644 now includes all matters related to c
44、lassification 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.Cleanrooms may also be characterized by attributes in addition to the classification of air cleanliness by partic
45、le concentration. Other attributes, such as air cleanliness in terms of chemical concentration, may ISO 2015 All rights reserved vBS EN ISO 14644-1:2015ISO 14644-1:2015(E)be monitored and the attributes grade or level may be designated along with the classification of the ISO Class of cleanliness. T
46、hese additional attributes do not suffice alone to classify a cleanroom or clean zone.vi ISO 2015 All rights reservedBS EN ISO 14644-1:2015INTERNATIONAL STANDARD ISO 14644-1:2015(E)Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration1
47、ScopeThis part of ISO 14644 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7.Only particle populations having cumulative distributions based on threshold (lower limit) parti
48、cle sizes ranging from 0,1 m to 5 m are considered for classification purposes.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 lo
49、cations.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 addressed 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).This part of ISO 14644 cannot be used to characterize the physical, chemical, radiological, via
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