DIN EN ISO 14644-1-2016 Cleanrooms and associated controlled environments - Part 1 Classification of air cleanliness by particle concentration (ISO 14644-1 2015) German version EN .pdf

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1、June 2016 English price group 20No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 13.040.35!%VpN“2517743www.din.deDIN

2、 EN ISO 14644-1Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015);English version EN ISO 14644-1:2015,English translation of DIN EN ISO 14644-1:2016-06Reinrume und zugehrige Reinraumbereiche Teil 1: Klassifizierung

3、 der Luftreinheit anhand der Partikelkonzentration (ISO 14644-1:2015);Englische Fassung EN ISO 14644-1:2015,Englische bersetzung von DIN EN ISO 14644-1:2016-06Salles propres et environnements matriss apparents Partie 1: Classification de la propret de lair (ISO 14644-1:2015);Version anglaise EN ISO

4、14644-1:2015,Traduction anglaise de DIN EN ISO 14644-1:2016-06SupersedesDIN EN ISO 14644-1:1999-07www.beuth.deDocument comprises 45 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.07.16DIN EN ISO 14644-1:2016-06 2 A comma is us

5、ed as the decimal marker. National 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 Committee CEN/TC 243 “Cleanroom technology” (Secretariat: BSI, United Kingdom). The

6、responsible German body involved in its preparation was DIN-Normenausschuss Heiz- und Raumlufttechnik (DIN Standards Committee Heating and Ventilation Technology), Working Committee NA 041-02-21 AA Reinraumtechnik (SpA CEN/TC 243 und ISO/TC 209). Amendments This standard differs from DIN EN ISO 1464

7、4-1:1999-07 as follows: a) the title has been changed to read “Classification of air cleanliness by particle concentration”; b) normative references have been included; c) a new Annex E “Specification of intermediate decimal cleanliness classes and particle size thresholds” has been added; d) a new

8、Annex F “Test instruments” has been added; e) Table 1 “ISO Classes of air cleanliness by particle concentration” giving the maximum allowable concentrations for particles of different sizes within the new cleanliness classes has been added; f) the determination of the maximum particle concentration

9、for intermediate classes by means of a formula has been specified; g) a more consistent statistical approach for the selection and number of sampling locations and the evaluation of data has been introduced. Previous editions DIN EN ISO 14644-1: 1999-07 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE N

10、ORM EN ISO 14644-1 December 2015 ICS 13.040.35 Supersedes EN ISO 14644-1:1999English Version Cleanrooms 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: Class

11、ification de la propret particulaire de lair (ISO 14644-1:2015) Reinrume und zugehrige Reinraumbereiche - 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

12、the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard 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 Managem

13、ent Centre or to any CEN member. This European Standard exists in three official versions (English, 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 statu

14、s as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

15、 Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, 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 Al

16、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-1:2015 EContents Page European foreword .3Introduction 51 Scope . 72 Normative references 73 Terms and definitions . 73.1 General . 73.2 Airborne particles 83.3 Occupancy states .

17、 93.4 Testing instrumentation (see Annex F) . 93.5 Instrument specifications . 104 Classification 104.1 Occupancy state(s) . 104.2 Particle size(s) 104.3 ISO Class number . 104.4 Designation . 114.5 Intermediate decimal cleanliness classes and particle size thresholds 115 Demonstration of compliance

18、 . 125.1 Principle . 125.2 Testing . 125.3 Airborne particle concentration evaluation . 125.4 Test report 12Annex A (normative) Reference method for classification of air cleanliness by particle concentration 14Annex B (informative) Examples of classification calculations 19Annex C (informative) Cou

19、nting and sizing of airborne macroparticles 28Annex D (informative) Sequential sampling procedure .33Annex E (informative) Specification of intermediate decimal cleanliness classes and particle size thresholds 40Annex F (informative) Test instruments .42Bibliography .43Foreword .42 EN ISO 14644-1:20

20、15 (E) DIN EN ISO 14644-1:2016-06European 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 Committee CEN/TC 243 “Cleanroom technology” the secretariat of which is held

21、by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 2016. Attention is drawn to the possibility that some

22、 of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14644-1:1999. According to the CEN-CENELEC Internal Regulations, the national standards organizations

23、 of the following 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, Latvia, Lithuania, Luxembourg, Malta, N

24、etherlands, 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 any modification. 3EN ISO 14644-1:2015 (E)DIN EN ISO 14644-1:2016-06Fo

25、rewordISO (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 tech

26、nical committee has been established has the right to be represented on that committee. International 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

27、 electrotechnical standardization.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 document

28、was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.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 pa

29、tent 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 (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not

30、 constitute an endorsement.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 informationT

31、he committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.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

32、Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness by particle concentration Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Part 3: Test methods Part 4: Design, construction and start-up P

33、art 5: Operations Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) 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

34、 by chemical concentrationAttention is also drawn to ISO 14698, Cleanrooms and associated controlled environments Biocontamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of biocontamination data4 EN ISO 14644-1:2015 (E) DIN EN ISO 14644-1:2016-06Introdu

35、ctionCleanrooms and associated controlled environments provide for the control of 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

36、applications in industries such as aerospace, microelectronics, pharmaceuticals, 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 t

37、esting to determine cleanliness class, including selection of sampling locations.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

38、cleanliness by particle concentration” 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 concent

39、ration at various particle sizes for intermediate 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 (formerl

40、y defined as ultrafine particles) will be addressed in a separate standard.The most 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 adaptati

41、on 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 co

42、mply 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 f

43、ollow the same normal distribution across the room, this assumption has now been 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 co

44、nsistently in ISO 14644-1:1999. The minimum number of sampling locations required 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. A

45、n assumption is made that the area immediately surrounding each sampling location 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 s

46、ampling location is placed within each grid section, so as to be representative of 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 disp

47、osition and airflow systems should be considered when selecting sampling locations. 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 an

48、nexes concerning testing and test instruments have been included from ISO 14644-3:2005.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.Th

49、e 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.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 of chemical concentration, may 5EN ISO 14644-1:2015 (E)DIN EN ISO 14644-1:2016-06be monitored and the