1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14644-9:2012Cleanrooms and associated controlled environmentsPart 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012)BS EN ISO 14644-9
2、:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 14644-9:2012.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e L B I / 3 0 , C l e a n r o o m t e c h n o l o g y .A list of organizations represented on this c
3、ommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 64583 9 ICS 13.
4、040.35 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2012.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EURO
5、PENNE EUROPISCHE NORM EN ISO 14644-9 August 2012 ICS 13.040.35 English Version Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration (ISO 14644-9:2012) Salles propres et environnements matriss apparents - Partie 9: Classification
6、de la propret des surfaces par la concentration de particules (ISO 14644-9:2012) Reinrume und zugehrige Reinraumbereiche - Teil 9: Klassifzierung der partikulren Oberflchenreinheit (ISO 14644-9:2012) This European Standard was approved by CEN on 14 August 2012. CEN members are bound to comply with t
7、he 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 Manageme
8、nt 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 status
9、 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,
10、Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of
11、exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-9:2012: EBS EN ISO 14644-9:2012EN ISO 14644-9:2012 (E) 3 Foreword This document (EN ISO 14644-9:2012) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled
12、 environments“ in 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, a
13、nd conflicting national 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. A
14、ccording to the CEN/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, Germ
15、any, Greece, Hungary, 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 146
16、44-9:2012 without any modification. BS EN ISO 14644-9:2012ISO 14644-9:2012(E) ISO 2012 All rights reserved iiiContents Page Foreword iv Introduction . v 1 Scope 1 2 Normative references 1 3 Terms and definitions . 1 4 Abbreviated terms . 2 5 Classification system 3 5.1 ISO-SCP classification format
17、3 5.2 Designation 6 5.3 General information on surface cleanliness by particle concentration 6 6 Demonstration of compliance 6 6.1 Principle . 6 6.2 Testing 6 6.3 Test report 7 Annex A (informative) Surface characteristics 9 Annex B (informative) Descriptor for specific particle size ranges . 12 Ann
18、ex C (informative) Parameters influencing the SCP classification . 15 Annex D (informative) Measurement methods for determining surface cleanliness by particle concentration . 17 Bibliography 25 BS EN ISO 14644-9:2012ISO 14644-9:2012(E) iv ISO 2012 All rights reservedForeword ISO (the International
19、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 esta
20、blished 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 electrotechnical standardiza
21、tion. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for votin
22、g. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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
23、patent rights. ISO 14644-9 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness Part 2: Specif
24、ications for monitoring to prove continued compliance with ISO 14644-1 Part 3: Test methods Part 4: Design, construction and start-up Part 5: Operations Part 6: Vocabulary Part 7: Separative devices (clean air hoods, gloveboxes, isolators, and mini-environments) Part 8: Classification of air cleanli
25、ness by chemical concentration Part 9: Classification of surface cleanliness by particle concentration Part 10: Classification of surface cleanliness by chemical concentration Attention is also drawn to ISO 14698, Cleanrooms and associated controlled environments Biocontamination control: Part 1: Ge
26、neral principles and methods Part 2: Evaluation and interpretation of biocontamination data BS EN ISO 14644-9:2012ISO 14644-9:2012(E) ISO 2012 All rights reserved vIntroduction Cleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomp
27、lishing contamination-sensitive activities. Products and processes that benefit from the control 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 I
28、SO 14698-1 and ISO 14698-2 (biological contamination) deal exclusively with airborne particle 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 envir
29、onments. These factors are covered in some detail in other parts of ISO 14644 and ISO 14698. 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 testin
30、g, as well as procedure(s) for determining the concentration of particles on surfaces. Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptations of the testing procedures might be required. BS EN ISO 14644-9:2012BS EN ISO 14644-9:2012INTERNATIONAL STANDARD IS
31、O 14644-9:2012(E) ISO 2012 All rights reserved 1Cleanrooms and associated controlled environments Part 9: Classification of surface cleanliness by particle concentration 1 Scope This part of ISO 14644 establishes the classification of cleanliness levels on solid surfaces by particle concentration in
32、 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 associated controlled environmen
33、ts, 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 14644: requirements for th
34、e 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 statistical methods for cl
35、assification 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 the edition cited applie
36、s. 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 definitions given in ISO 14644-
37、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 BS EN ISO 14644-9:2012ISO 14644-9:2012(E) 2 ISO 2012 All rights reservedNOTE The descriptor may be applied to particle size ranges of
38、 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 method ass
39、essment 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 part
40、icles 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 acting
41、 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 1 to
42、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 an IS
43、O 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 dispersiv
44、e X-ray spectroscopy ESCA electron spectroscopy for chemical analysis ESD electrostatic discharge BS EN ISO 14644-9:2012ISO 14644-9:2012(E) ISO 2012 All rights reserved 3IR infrared (absorption spectroscopy) OPC optical particle counter PET polyethylene terephthalate SCP surface cleanliness by parti
45、cle concentration 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
46、 shall be designated 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
47、 per square metre 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
48、whole number, 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 p
49、articles at the 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. NOTE 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 t
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