1、BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06Cleanrooms and associated controlled environmentsPart 15: Assessment of suitability for use of equipment and materials by airborne chemical concentrationBS EN ISO 1464415:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE
2、 NORM EN ISO 14644-15 December 2017 ICS 13.040.35 English Version Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017) Salles propres et environnements matriss apparents - Part
3、ie 15: valuation de laptitude lemploi des quipements et des matriaux par la dtermination de la concentration chimique aroporte (ISO 14644-15:2017) Reinrume und zugehrige Reinraumbereiche - Teil 15: Bewertung der Reinraumtauglichkeit von Gerten und Materialien anhand der chemischen Luft- und Oberflch
4、enkonzentration (ISO 14644-15:2017) This European Standard was approved by CEN on 27 October 2017. 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-t
5、o-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 version in any other language made by transla
6、tion 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, Czech Republic, Denmark, Estonia, Finland,
7、 Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDI
8、ZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-15:2017 ENational forewordThis
9、 British Standard is the UK implementation of EN ISO 1464415:2017. It is identical to ISO 1464415:2017.The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology.A list of organizations represented on this committee can be obtained on request to its sec
10、retary.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 2018 Published by BSI Standards Limited 2018ISBN 978 0 580 85502 3ICS 13.040.35Compliance with a British Standard canno
11、t confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2018.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 1464415:2017EUROPEAN STANDARD NORME EUROPENNE E
12、UROPISCHE NORM EN ISO 14644-15 December 2017 ICS 13.040.35 English Version Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017) Salles propres et environnements matriss apparen
13、ts - Partie 15: valuation de laptitude lemploi des quipements et des matriaux par la dtermination de la concentration chimique aroporte (ISO 14644-15:2017) Reinrume und zugehrige Reinraumbereiche - Teil 15: Bewertung der Reinraumtauglichkeit von Gerten und Materialien anhand der chemischen Luft- und
14、 Oberflchenkonzentration (ISO 14644-15:2017) This European Standard was approved by CEN on 27 October 2017. 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 alterat
15、ion. 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 version in any other language made b
16、y 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, Czech Republic, Denmark, Estonia,
17、 Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR
18、STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-15:2017 EBS EN ISO 14
19、64415:2017EN ISO 14644-15:2017 (E) 3 European foreword This document (EN ISO 14644-15:2017) 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
20、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 June 2018 and conflicting national standards shall be withdrawn at the latest by June 2018. Attention is drawn to the possibility that
21、some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this E
22、uropean 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, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sl
23、ovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 14644-15:2017 has been approved by CEN as EN ISO 14644-15:2017 without any modification. BS EN ISO 1464415:2017ISO 14644-15:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative reference
24、s 13 Terms and definitions . 14 Symbols 45 Test setup . 55.1 General . 55.2 Closed design 55.3 Closed design special application . 65.4 Open design . 76 Representative mode . 76.1 Equipment . 76.2 Material . 77 Visual inspection 87.1 General . 87.2 Equipment . 87.3 Material . 88 Test description . 9
25、9 Calculation of the measured concentrations 910 Calculation of specific emission rate 1010.1 Calculation of specific emission rate Closed design .1010.2 Calculation of specific emission rate Open design .1111 Assessment 1111.1 General 1111.2 Required input data . 1211.3 Calculation to determine the
26、 effect on a cleanroom or controlled zone 1211.4 Assessment of the suitability of material(s) or equipment for an existing cleanroom or controlled zone . 1312 Documentation 1312.1 General 1312.2 Common documentation requirements . 1312.3 Test documentation . 1412.4 Visual inspection 1412.4.1 Equipme
27、nt 1412.4.2 Materials 14Annex A (informative) Example calculation for suitability assessment of one equipment (existing installation) .15Annex B (informative) Example calculation for suitability assessment of wall material (existing cleanroom/clean zone installation) 17Annex C (informative) Suitabil
28、ity assessment of a combination of equipment and floor material in a cleanroom to be designed 19Bibliography .21 ISO 2017 All rights reserved iiiContents PageBS EN ISO 1464415:2017ISO 14644-15:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of nation
29、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
30、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
31、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.
32、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
33、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 voluntary nature of standards, the meaning of
34、 ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.This document was prepared by Technical Com
35、mittee ISO/TC 209, Cleanrooms and associated controlled environments.A list of all parts in the ISO 14644 series can be found on the ISO website.iv ISO 2017 All rights reservedBS EN ISO 1464415:2017ISO 14644-15:2017(E)IntroductionCleanrooms and associated controlled environments provide for the cont
36、rol of contamination to levels appropriate for accomplishing 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
37、, food, healthcare).This document addresses the cleanroom classification of air cleanliness by chemical concentration to the suitability of equipment for use in cleanrooms and associated controlled environments.Examples and suitability assessments are given in Annexes A, B and C. ISO 2017 All rights
38、 reserved vBS EN ISO 1464415:2017Cleanrooms and associated controlled environments Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration1 ScopeThis document provides requirements and guidelines for assessing the chemical airborne cleanliness of equi
39、pment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644-8).The following are outside the scope of this document: health and safety requirements; compat
40、ibility with cleaning agents and techniques; cleanability; biocontamination; specific requirements of equipment and materials for processes and products; design details of equipment.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their cont
41、ent constitutes requirements 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 14644-8:2013, Cleanrooms and associated controlled environments Part 8: Classification of
42、air cleanliness by chemical concentration (ACC)3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: ISO Online browsing platform: available at https:/ww
43、w.iso.org/obp IEC Electropedia: available at http:/www.electropedia.org/3.1air chemical contaminationany non-particulate chemical specie(s) in the air that can, by its chemical nature, adversely affect the product, process or equipmentSOURCE: ISO 14644-8:2013, 3.1.3, modified “substance” has been re
44、placed by “non-particulate chemical specie(s)”.INTERNATIONAL STANDARD ISO 14644-15:2017(E) ISO 2017 All rights reserved 1BS EN ISO 1464415:2017ISO 14644-15:2017(E)3.2air cleanliness by chemical concentrationACClevel of air cleanliness (3.5) by chemical concentration, expressed in terms of an ISO-ACC
45、 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 macromolecules of biological origin, which are judged to be particles.SOURCE: ISO 14644-8:201
46、3, 3.1.23.3breakthrough volumemaximum purge gas (3.14) volume that can be drawn through a trapping system without loss of analyte at a specific temperature3.4chemical contaminationnon-particulate substances that can have a deleterious effect on the product, process or equipmentSOURCE: ISO 14644-8:20
47、13, 3.1.13.5cleanlinesscondition not exceeding a specified level of contamination3.6cleanroomroom within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation, and retenti
48、on of particles inside the roomNote 1 to entry: The class of airborne particle concentration is specified.Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical an
49、d viable concentrations may also be specified and controlled.Note 3 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.SOURCE: ISO 14644-1:2015, 3.1.13.7cleanroom suitabilityability to maintain the critical control attributes or condition of any clean zone (3.8) when used as intendedNote 1 to entry: For the purposes of this document, the assessment is based on air chemical concentration.Note 2 to
