1、BS EN ISO 14644-14:2016Cleanrooms and associatedcontrolled environmentsPart 14: Assessment of suitability foruse of equipment by airborne particleconcentration (ISO 14644-14:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 14644-14:2016 BRITISH STANDARD
2、National forewordThis British Standard is the UK implementation of EN ISO 14644-14:2016. BSI, as a member of CEN, is obliged to publish EN ISO 14644-14:2016 as a British Standard. However, attention is drawn to the fact that during the development of this European Standard, the UK committee voted ag
3、ainst its approval as a European Standard.The UK committee is of the opinion that a lack of emphasis has been placed on the importance and value of the optional “Total emission measurement method” described in informative clause B.4. In particular, this method provides important information that can
4、 be used to determine the required supply air volume in non-unidirectional airflow cleanrooms to mitigate the airborne particle load in the room. Calculated supply air volume requirements are an essential part of BS EN ISO 14644-4:2001 and the forthcoming ISO 14644-16 standard. In addition, the UK c
5、ommittee views that the method specified in clause 6 described as “measurement of air-borne particle emissions at critical locations”, should be used with caution. High levels of particle generation from some equipment can be mitigated by the use of local exhaust ventilation to prevent an adverse ef
6、fect on the room class at critical control points due to migration of airborne particles.In light of these concerns, the UK committee refers users of this standard to the paragraph at the end of clause 4 which states, “The method described in B.4 may be used to determine the aver-age total emission
7、of equipment and provides data that may be used to determine the particle load on a cleanroom”. The UK committee advises that clause B.4 be utilised to allow the customer and supplier to select this method when it is more appropriate than the method described in clause 6. The reason for this decisio
8、n should be documented when claiming conformance with BS EN ISO 14644-14:2016.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 secretary.This publication d
9、oes not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82493 7ICS 13.040.35Compliance with a British Standard cannot confer immunity from le
10、gal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-14 October 2016 ICS 13.04
11、0.35 English Version Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016) Salles propres et environnements matriss apparents - Partie 14: valuation de laptitude lemploi des quipements par la
12、 dtermination de la concentration de particules en suspension dans lair (ISO 14644-14:2016) Reinrume und zugehrige Reinraumbereiche - Teil 14: Bewertung der Reinraumtauglichkeit von Gerten durch Partikelkonzentration in der Luft (ISO 14644-14:2016) This European Standard was approved by CEN on 13 Au
13、gust 2016. 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 standards may be ob
14、tained 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 notified to the
15、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, Iceland, Irela
16、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, 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 Centr
17、e: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-14:2016 EBS EN ISO 14644-14:2016EN ISO 14644-14:2016 (E) 3 European foreword This document (EN ISO 14644-14:2016) has been prepared
18、 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 by BSI. This European Standard shall be given the status of a national standard, either by publication o
19、f an identical text or by endorsement, at the latest by April 2017, and conflicting national standards shall be withdrawn at the latest by April 2017. 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
20、 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 European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Est
21、onia, 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 Kingdom. Endorsement notice The
22、 text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any modification. BS EN ISO 14644-14:2016ISO 14644-14:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 General outline of the assessment . 35 Visual inspection 36 Assess
23、ment of suitability by airborne particle concentration measurements . 46.1 General . 46.2 Assessment procedure . 46.2.1 Overview . 46.2.2 Requirements and considerations 56.2.3 Representative mode of operation . 66.2.4 Considerations for the test environment 66.2.5 Determination of the test environm
24、ent . 66.2.6 Approximate identification of HPC location(s) . 66.2.7 Precise determination of HPC location(s) 76.2.8 Suitability measurement(s) 76.2.9 Data processing . 86.2.10 Reference to ISO 146441 classification system 107 Documentation 107.1 General 107.2 Common documentation requirements . 107.
25、3 Documentation for visual inspection . 117.4 Documentation for assessment of test environment 117.5 Documentation for classification measurement .128 Statement on cleanroom suitability 12Annex A (informative) Example for data processing deriving from measurements .14Annex B (informative) Additional
26、 optional tests 18Bibliography .21 ISO 2016 All rights reserved iiiContents PageBS EN ISO 14644-14:2016ISO 14644-14:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International
27、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 organizations, governmental and non-governmental, in liaison with ISO, al
28、so 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 for its further maintenance are described in the ISO/IEC Directives, Part 1.
29、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.org/directives).Attention is drawn to the possibility that some of the elemen
30、ts 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 be in the Introduction and/or on the ISO list of patent declarations received
31、(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 meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherenc
32、e to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.A list of all part in the ISO 14644 series, p
33、ublished under the general title Cleanrooms and associated controlled environments, can be found on the ISO website.iv ISO 2016 All rights reservedBS EN ISO 14644-14:2016ISO 14644-14:2016(E)IntroductionCleanrooms and associated controlled environments provide for the control of contamination to leve
34、ls appropriate for accomplishing contaminationsensitive 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 and healthcare).This pa
35、rt of ISO 14644 links the cleanroom classification of air cleanliness by particle concentration to the suitability of equipment for use in cleanrooms and associated controlled environments. ISO 2016 All rights reserved vBS EN ISO 14644-14:2016BS EN ISO 14644-14:2016Cleanrooms and associated controll
36、ed environments Part 14: Assessment of suitability for use of equipment by airborne particle concentration1 ScopeThis part of ISO 14644 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms
37、and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 146441. Particle sizes range from 0,1 m to equal to or larger than 5 m (given in ISO 14644-1).NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptati
38、on of the assessment methodology can be required.The following items are not covered by this part of ISO 14644: assessment of suitability with respect to biocontamination; testing for suitability of decontamination agents and techniques; cleanability of equipment and materials; requirements on desig
39、n of equipment and selection of materials; physical properties of materials (e.g. electrostatic, thermal properties); optimizing performance of equipment for specific process applications; selection and use of statistical methods for testing; protocols and requirements for local safety regulations.2
40、 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendme
41、nts) applies.ISO 14644-1:2015, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1cleanlinesscondition not exceeding a specified le
42、vel of contaminationINTERNATIONAL STANDARD ISO 14644-14:2016(E) ISO 2016 All rights reserved 1BS EN ISO 14644-14:2016ISO 14644-14:2016(E)3.2cleanroomroom within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a man
43、ner to control the introduction, generation and retention 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 c
44、leanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.SOURCE: ISO 14644-1:2015,
45、3.1.13.3cleanroom suitabilityability to maintain the critical control attributes or condition of any clean zone when used as intendedNote 1 to entry: For the purposes of this part of ISO 14644, the assessment is based on airborne particle concentration.3.4clean zonedefined space within which the num
46、ber concentration of airborne particles is controlled and classified, and which is constructed and operated in a manner to control the introduction, generation and retention of contaminants inside the spaceNote 1 to entry: The class of airborne particle concentration is specified.Note 2 to entry: Le
47、vels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified and controlled.Note 3 to entry: A clean zone(s) can be a defined space within
48、 a cleanroom or might be achieved by a separative device. Such a device can be located inside or outside a cleanroom.Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity, pressure, vibration and electrostatic.SOURCE: ISO 14644-1:2015, 3
49、.1.23.5decontaminationreduction of unwanted matter to a defined levelSOURCE: ISO 14644-7:2004, 3.73.6equipmentsystem designed for specific function(s), integrating materials, components and/or controlsEXAMPLE Testing and manufacturing equipment and machinery, equipment for transport and handling, storage units, tools, furniture, doors, ceilings, Information Technology (IT) hardware and handling robots.3.7test environmentspace in which the test is carried out, described by a set of parameters2 ISO 2016 All rights reservedBS EN I
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