1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14644-8:2013Cleanrooms and associated controlled environmentsPart 8: Classification of air cleanliness by chemical concentration (ACC)BS EN ISO 14644-8:2013 BRITISH STA
2、NDARDNational forewordThis British Standard is the UK implementation of EN ISO 14644-8:2013. It is identical to ISO 14644-8:2013. It supersedes BS EN ISO 14644-8:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology.A list o
3、f organizations represented on this committee 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 2013. Published by BSI Standards Lim
4、ited 2013ISBN 978 0 580 75693 1 ICS 13.040.35 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 28 February 2013.Amendments issued since publicationDate Text affec
5、tedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-8 February 2013 ICS 13.040.35 Supersedes EN ISO 14644-8:2006English Version Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013) Salles propre
6、s et environnements matriss apparents - Partie 8: Classification de la propret chimique de lair (ISO 14644-8:2013) Reinrume und zugehrige Reinraumbereiche - Teil 8: Klassifizierung der Luftreinheit anhand der Chemikalienkonzentration (ACC) (ISO 14644-8:2013) This European Standard was approved by CE
7、N on 9 February 2013. 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 national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standard
8、s 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 version in any other language made by translation under the responsibility of a CEN member into its own language and notif
9、ied 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Ice
10、land, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, 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 Centr
11、e: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-8:2013: EBS EN ISO 14644-8:2013EN ISO 14644-8:2013 (E) 3 Foreword This document (EN ISO 14644-8:2013) has been prepared by Technica
12、l Committee ISO/TC 209 “Cleanroomsand associated controlled environments“ in collaboration with Technical Committee CEN/TC 243 “Cleanroomtechnology” 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
13、text or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn atthe latest by August 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC shall not be held responsib
14、le for identifying any or all such patent rights. This document supersedes EN ISO 14644-8:2006. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus
15、, CzechRepublic, 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 the United King
16、dom. Endorsement notice The text of ISO 14644-8:2013 has been approved by CEN as EN ISO 14644-8:2013 without any modification. BS EN ISO 14644-8:2013ISO 14644-8:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions .
17、13.1 General . 13.2 Contaminant categories 24 Classification 34.1 General . 34.2 ISO-ACC descriptor format . 35 Demonstration of compliance 55.1 Principle 55.2 Testing 55.3 Test report . 6Annex A (informative) Parameters for consideration 7Annex B (informative) Typical contaminants 11Annex C (inform
18、ative) Typical methods of measurement .15Annex D (informative) Consideration of specific requirements for separative devices 19Bibliography .21BS EN ISO 14644-8:2013ISO 14644-8:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bod
19、ies (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. International organization
20、s, 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.International Standards are drafted in accordance with the rules given in the IS
21、O/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 voting. Publication as an International Standard requires approval by at least 75 % of the m
22、ember 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 patent rights.ISO 14644-8 was prepared by Technical Committee ISO/TC 209, Cleanrooms and
23、 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: Specifications for testing and monitoring to prove continued compliance with ISO 146441 Part 3:
24、Test methods Part 4: Design, construction and startup Part 5: Operations Part 6: Vocabulary Part 7: Separative devices (clean air hoods, gloveboxes, isolators, minienvironments) Part 8: Classification of air cleanliness by chemical concentration (ACC) Part 9: Classification of surface cleanliness by
25、 particle concentration Part 10: Classification of surface cleanliness by chemical concentrationThis second edition cancels and replaces the first edition (ISO 14644-8:2006), which has been technically revised.iv ISO 2013 All rights reservedBS EN ISO 14644-8:2013ISO 14644-8:2013(E)IntroductionCleanr
26、ooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include those in such industries as aer
27、ospace, microelectronics, pharmaceuticals, medical devices, food, healthcare, optics, instrumentation, vacuum technology, coatings, photovoltaics, displays, LEDs, coatings, automotive and surface analysis.In some of these industries, the product or process can be sensitive to, or can be destroyed by
28、, chemical contamination resulting from chemicals that are present due to external, process, or otherwise generated sources.Within this part of ISO 14644, the presence of chemicals is expressed as air chemical contamination. Chemical contamination is a three-step event. The first step is generation
29、due to external sources such as process leakage or construction material or personnel or material outgassing. The second step is transport as airborne chemical contamination. The third step is sorption on the sensitive surface, which can be quantified as a surface chemical contamination.The generati
30、ng materials and the surfaces where sorption takes place will have a large influence on the steps of generation and sorption in addition to the actual air contamination. Thus, for these two steps, not only the contaminants but also the involved bulk and surfaces need to be defined. In order to make
31、a standard generally applicable to any type of cleanroom or associated controlled environment, air chemical cleanliness (ACC) has been chosen for the classification.This part of ISO 14644 assigns ISO classification levels to be used to specify the level of ACC within a cleanroom and associated contr
32、olled environment, where the product or process is deemed to be at risk from air chemical contamination.For classification purposes, this part of ISO 14644 is limited to a designated range of ACC and provides standard protocols for specifying such levels with regard to chemical compounds, methods of
33、 test and analysis, and time weighted factors.Informative annexes are contained in this part of ISO 14644 covering: parameters for consideration: Annex A; typical contaminating chemicals and substances: Annex B; typical methods of measurement and analysis: Annex C; considerations of specific require
34、ments for separative devices: Annex D.This part of ISO 14644 is one of a series of standards concerned with cleanrooms and contamination control. Many factors besides ACC need to be considered in the design, specification, operation and control of cleanrooms and other controlled environments. These
35、are covered in some detail in other parts of the International Standards prepared by ISO/TC 209, including ISO 14698 (all parts).4In some circumstances, relevant regulatory agencies can impose supplementary policies or restrictions. In such situations, appropriate adaptations of this part of ISO 146
36、44 can be required. ISO 2013 All rights reserved vBS EN ISO 14644-8:2013BS EN ISO 14644-8:2013Cleanrooms and associated controlled environments Part 8: Classification of air cleanliness by chemical concentration (ACC)1 ScopeThis part of ISO 14644 establishes the classification of air chemical cleanl
37、iness (ACC) in cleanrooms and associated controlled environments, in terms of airborne concentrations of specific chemical substances (individual, group or category) and provides a protocol to include test methods, analysis and time-weighted factors within the specification for classification.This p
38、art of ISO 14644 currently considers only concentrations of air chemical contaminants between 100and 1012g/m3under cleanroom operational conditions.This part of ISO 14644 is not relevant for application in those industries, processes or productions where the presence of airborne chemical substances
39、is not considered a risk to the product or process.It is not the intention of this part of ISO 14644 to describe the nature of air chemical contaminants.This part of ISO 14644 does not give a classification of surface chemical contamination.2 Normative referencesThe following referenced documents ar
40、e indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 14644-6, Cleanrooms and associated controlled environments Part 6: Vocabulary3 Term
41、s and definitionsFor the purposes of this document, the terms and definitions given in ISO 14644-6 and the following apply.3.1 General3.1.1chemical contaminationnon-particulate substances that can have a deleterious effect on the product, process or equipment3.1.2air cleanliness by chemical concentr
42、ationACClevel of air cleanliness by chemical concentration, expressed in terms of an ISO-ACC Class N, which represents the maximum allowable concentration of a given chemical species or a group of chemical species, expressed in grams per cubic metreNote 1 to entry: This definition does not include m
43、acromolecules of biological origin, which are judged to be particles.3.1.3air chemical contaminationany substance in the air that can, by its chemical nature, adversely affect the product, process or equipmentINTERNATIONAL STANDARD ISO 14644-8:2013(E) ISO 2013 All rights reserved 1BS EN ISO 14644-8:
44、2013ISO 14644-8:2013(E)3.1.4surface cleanliness by chemical concentrationSCCcondition of the surface cleanliness with respect to its chemical concentration3.1.5surface chemical contaminationany substance on the surface that can, by its chemical nature, adversely affect the product, process or equipm
45、ent3.1.6contaminant categorycommon name for a group of compounds with a specific and similar deleterious effect when deposited on the surface of interest3.1.7outgassingrelease of chemical substances in the gaseous or vapour state from a material3.1.8air cleanliness by chemical concentration (ACC) cl
46、assgrading number stating the maximum allowable concentration of a given chemical species or a group of chemical species in grams per cubic metreNote 1 to entry: The maximum allowable concentrations are defined in Table 1 or determined by the equation for N in 4.2.Note 2 to entry: Classification in
47、accordance with this part of ISO 14644 is limited to the range from 0 (the class with the lowest allowable cleanliness) to 12 (the cleanest specified class).Note 3 to entry: The ACC class number is only valid in connection with the ACC descriptor that specifies to which chemical species or group of
48、chemical species it is related.Note 4 to entry: The negative sign of the air chemical cleanliness classes (1 to 12) is an integral part of the ACC class number N and must always be given. An air chemical cleanliness class without the negative sign (with the exception of the class 0) is not allowed.N
49、ote 5 to entry: Intermediate ISO classification numbers may be specified, with 0,1 being the smallest permitted increment.3.2 Contaminant categories3.2.1acidsubstance whose chemical reaction characteristic is to establish new bonds by the acceptance of electron pairs3.2.2basesubstance whose chemical reaction characteristic is to establish new bonds by the donation of electron pairs3.2.3biotoxiccontaminant substance that is obnoxious to the development and preservation of the life of organisms, microorganisms, tissues or individual cells
