DIN EN ISO 14644-9-2012 Cleanrooms and associated controlled environments Part 9 Classification of surface cleanliness by particle concentration (ISO 14644-9 2012) German version E.pdf

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1、December 2012 Translation by DIN-Sprachendienst.English price group 14No 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).I

2、CS 13.040.35!$9“1929122www.din.deDDIN EN ISO 14644-9Cleanrooms and associated controlled environments Part 9: Classification of surface cleanliness by particle concentration(ISO 14644-9:2012);English version EN ISO 14644-9:2012,English translation of DIN EN ISO 14644-9:2012-12Reinrume und zugehrige

3、Reinraumbereiche Teil 9: Klassifizierung der partikulren Oberflchenreinheit (ISO 14644-9:2012);Englische Fassung EN ISO 14644-9:2012,Englische bersetzung von DIN EN ISO 14644-9:2012-12Salles propres et environnements matriss apparents Partie 9: Classification de la propret des surfaces par la concen

4、tration en particules(ISO 14644-9:2012);Version anglaise EN ISO 14644-9:2012,Traduction anglaise de DIN EN ISO 14644-9:2012-12www.beuth.deDocument comprises 32 pagesIn case of doubt, the German-language original shall be considered authoritative.11.12 DIN EN ISO 14644-9:2012-12 2 A comma is used as

5、the decimal marker. National foreword This standard 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 responsible German body invo

6、lved in its preparation was the Normenausschuss Heiz- und Raumluft-technik (Heating and Ventilation Technology Standards Committee). The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4287 DIN EN ISO 4287 ISO 4288 DIN EN ISO 4288 ISO 5725-

7、2 DIN ISO 5725 ISO 10576-1 DIN ISO 10576-1 ISO 14644-6 DIN EN ISO 14644-6 IEC 61340-5-1 DIN EN 61340-5-1 (VDE 0300-5-1) National Annex NA (informative) Bibliography DIN EN ISO 4287:2010-07, Geometrical Product Specifications (GPS) Surface texture: Profile method Terms, definitions and surface textur

8、e parameters DIN EN ISO 4288:1998-04, Geometrical Product Specifications (GPS) Surface texture: Profile method Rules and procedures for the assessment of surface texture DIN ISO 5725-2:2002-12, Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determin

9、ation of repeatability and reproducibility of a standard measurement method DIN ISO 10576-1:2009-10, Statistical methods Guidelines for the evaluation of conformity with specified requirements Part 1: General principles DIN EN ISO 14644-6:2007-10, Cleanrooms and associated controlled environments Pa

10、rt 6: Vocabulary DIN EN 61340-5-1 (VDE 0300-5-1):2008-07, Electrostatics Part 5-1: Protection of electronic devices from electrostatic phenomena General requirements EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-9 August 2012 ICS 13.040.35 English Version Cleanrooms and associated c

11、ontrolled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012) Salles propres et environnements matriss apparents - Partie 9: Classification de la propret des surfaces par la concentration de particules (ISO 14644-9:2012) Reinrume und zugehrige Re

12、inraumbereiche - Teil 9: Klassifizierung der partikulren Oberflchenreinheit This European Standard was approved by CEN on 14 August 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nationa

13、l 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 (English, French, German). A versio

14、n 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, Bulgaria, Croatia, Cyprus, Cze

15、ch 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, Switzerland, Turkey and United Kingdom. E

16、UROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-9:2012: E(ISO 1

17、4644-9:2012) Contents Page Foreword 3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Abbreviated terms .6 5 Classification system 7 5.1 ISO-SCP classification format 7 5.2 Designation 10 5.3 General information on surface cleanliness by particle concentration .10 6 D

18、emonstration of compliance 10 6.1 Principle 10 6.2 Testing 10 6.3 Test report 11 Annex A (informative) Surface characteristics 13 Annex B (informative) Descriptor for specific particle size ranges .16 Annex C (informative) Parameters influencing the SCP classification .19 Annex D (informative) Measu

19、rement methods for determining surface cleanliness by particle concentration .21 Bibliography 29 2 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) Foreword This document (EN ISO 14644-9:2012) has been prepared by Technical Committee ISO/TC 209 Cleanrooms and associated controlled environments” in

20、 collaboration with Technical Committee CEN/TC 243 “Cleanroom 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 an identical text or by endorsement, at the latest by February 2013, and conflicting na

21、tional standards shall be withdrawn at the latest by February 2013. Attention is drawn to the possibility that some 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. According to the C

22、EN/CENELEC Internal Regulations, the national standards organisations 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, Hung

23、ary, Iceland, Ireland, Italy, 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 14644-9:2012 has been approved by CEN as a EN ISO 14644-9:2012 without

24、 any modification. “ 3 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) Introduction Cleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the c

25、ontrol of contamination include those in such industries as aerospace, microelectronics, optics, nuclear, and life sciences (pharmaceuticals, medical devices, food, healthcare). ISO 14644-1 to ISO 14644-8 and ISO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne parti

26、cle and chemical contamination. Many factors, besides the classification of surface cleanliness, should be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These factors are covered in some detail in other parts of ISO 14644 and ISO 1469

27、8. This part of ISO 14644 provides a classification for the determination and designation of surface cleanliness levels based on particle concentrations. This part of ISO 14644 also lists some methods of testing, as well as procedure(s) for determining the concentration of particles on surfaces. Whe

28、re regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptations of the testing procedures might be required. 4 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) 1 Scope This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by p

29、article concentration in cleanrooms and associated controlled environment applications. Recommendations on testing and measuring methods, as well as information about surface characteristics, are given in Annexes A to D. This part of ISO 14644 applies to all solid surfaces in cleanrooms and associat

30、ed controlled environments, such as walls, ceilings, floors, working environments, tools, equipment and products. The classification of surface cleanliness by particle concentration (SCP) is limited to particles between 0,05 m and 500 m. The following issues are not considered in this part of ISO 14

31、644: requirements for the cleanliness and suitability of surfaces for specific processes; procedures for the cleaning of surfaces; material characteristics; references to interactive bonding forces or generation processes that are usually time-dependent and process-dependent; selection and use of st

32、atistical methods for classification and testing; other characteristics of particles, such as electrostatic charge, ionic charges, microbiological state, etc. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only

33、the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14644-6:2007, Cleanrooms and associated controlled environments Part 6: Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definit

34、ions given in ISO 14644-6:2007 and the following apply. 3.1 descriptor for specific particle size ranges differential descriptor that expresses SCP level within specific particle size ranges 5 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) NOTE The descriptor may be applied to particle size rang

35、es of special interest or those particle size ranges that are outside the range of the classification system, and specified independently or as a supplement to the SCP classes. 3.2 direct measurement method assessment of the contamination without any intermediate steps 3.3 indirect measurement metho

36、d assessment of the contamination with intermediate steps 3.4 solid surface boundary between the solid and a second phase 3.5 surface particle solid and/or liquid matter adhered and discretely distributed on a surface of interest, excluding film-like matter that covers the whole surface NOTE Surface

37、 particles are adhered via chemical and/or physical interactions. 3.6 surface cleanliness by particle concentration SCP condition of a surface with respect to its particle concentration NOTE The surface cleanliness depends upon material and design characteristics, stress loads (complexity of loads a

38、cting on a surface) and prevailing environmental conditions, along with other factors. 3.7 surface cleanliness by particle concentration class SCP class grading number stating the maximum allowable surface concentration, in particles per square metre, for a considered size of particles (SCP Classes

39、1 to 8) 3.8 surface cleanliness by particle concentration classification SCP classification level (or the process of specifying or determining the level) that represents maximum allowable surface concentrations, in particles per square metre, for considered sizes of particles, expressed in terms of

40、an ISO SCP Class N 3.9 surface particle concentration number of individual particles per unit of surface area under consideration 4 Abbreviated terms For the purposes of this document, the following abbreviated terms apply. AFM atomic force microscopy CNC condensation nucleus counter EDX energy disp

41、ersive X-ray spectroscopy ESCA electron spectroscopy for chemical analysis ESD electrostatic discharge 6 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) IR infrared (absorption spectroscopy) OPC optical particle counter PET polyethylene terephthalate SCP surface cleanliness by particle concentrat

42、ion SEM scanning electron microscopy UV ultraviolet (spectroscopy) WDX wavelength-dispersive X-ray spectroscopy 5 Classification system 5.1 ISO-SCP classification format The class of surface cleanliness by particle concentration (SCP) in a cleanroom or associated controlled environment shall be desi

43、gnated by a classification number, N, specifying the maximum total particle concentration on surfaces permitted for a considered particle size. N shall be determined from the following equation with the maximum permitted total particle concentration on the surface, CSCP;D, in particles per square me

44、tre of surface, for each considered particle size, D: SCP;D10NCkD (1) where CSCP;Dis the maximum permitted total surface concentration, in particles per square metre of surface, of particles that are equal to or larger than the considered particle size; CSCP;Dis rounded to the nearest whole number,

45、using no more than three significant figures; N is the SCP classification number, which is limited to SCP Class 1 through SCP Class 8; SCP Class number N is represented by the measured particle diameter D, in micrometres; NOTE N refers to the exponent base 10 for the concentration of particles at th

46、e reference particle size of 1 m. D is the considered particle size, in micrometres. k is a constant 1, in micrometres. NOTE 1 The SCP class based on the particle concentration can be a time- and process-dependent value due to the dynamic characteristics of particle generation and transportation. NO

47、TE 2 Due to the complexity of statistical evaluations and readily available additional references, the selection and use of statistical methods for classification and testing are not described in this part of ISO 14644. The concentration CSCP;D, as derived from Equation (1), shall serve as the defin

48、itive value. Table 1 presents selected SCP classes and corresponding maximum cumulative permitted total surface concentrations for considered particle sizes. Figure 1 provides a representation of the selected classes in graphical form. 7 DIN EN ISO 14644-9:2012-12 EN ISO 14644-9:2012 (E) Table 1 Selected SCP classes for cleanrooms and associated controlled environments Units in particles per square metre SCP Class Particle size R 0,05 m R 0,1 m R 0,5 m R 1 m R 5 m R 10 m R 50 m R 100 m R 500