DIN EN ISO 14644-14-2017 Cleanrooms and associated controlled environments - Part 14 Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14.pdf

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1、January 2017 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).ICS 13.040.35!%_5“2605918www.din.deD

2、IN EN ISO 14644-14Cleanrooms and associated controlled environments Part 14: Assessment of suitability for use of equipment by airborne particleconcentration (ISO 1464414:2016);English version EN ISO 1464414:2016,English translation of DIN EN ISO 14644-14:2017-01Reinrume und zugehrige Reinraumbereic

3、he Teil 14: Bewertung der Reinraumtauglichkeit von Gerten durch Partikelkonzentration in der Luft (ISO 1464414:2016);Englische Fassung EN ISO 1464414:2016,Englische bersetzung von DIN EN ISO 14644-14:2017-01Salles propres et environnements matriss apparents Partie 14: valuation de laptitude lemploi

4、des quipements par la dtermination de la concentration de particules en suspension dans lair (ISO 1464414:2016);Version anglaise EN ISO 1464414:2016,Traduction anglaise de DIN EN ISO 14644-14:2017-01www.beuth.deDocument comprises 28 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the Germa

5、n-language original shall be considered authoritative.01.17 DIN EN ISO 14644-14:2017-01 2 A comma is used as the decimal marker. National foreword This document (EN ISO 14644-14:2016) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments” in collabora

6、tion with Technical Committee CEN/TC 243 “Cleanroom technology” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was DIN-Normenausschuss Heiz- und Raumlufttechnik (DIN Standards Committee Heating and Ventilation Technology), Working Committee NA 041-02-21 A

7、A Reinraumtechnik (SpA CEN/TC 243 und ISO/TC 209). The DIN Standard corresponding to the International Standard referred to in Clause 2 of this standard is as follows: ISO 14644-1 DIN EN ISO 14644-1 National Annex NA (informative) Bibliography DIN EN ISO 14644-1, Cleanrooms and associated controlled

8、 environments Part 1: Classification of air cleanliness by particle concentration VDI 2083-9.1, Clean room technology Compatibility with required cleanliness and surface cleanliness EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-14 October 2016 ICS 13.040.35 English Version Cleanroom

9、s 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 dtermination de la concentrati

10、on 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 August 2016. CEN members are bound t

11、o 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 obtained on application to the CEN-C

12、ENELEC 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 CEN-CENELEC Management Centre has

13、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, Ireland, Italy, Latvia, Lithuania, Luxe

14、mbourg, 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 Centre: Avenue Marnix 17, B-1000 Brusse

15、ls 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 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 General outline of the assessment . 85 Visual inspection 8

16、6 Assessment of suitability by airborne particle concentration measurements . 96.1 General . 96.2 Assessment procedure . 96.2.1 Overview . 96.2.2 Requirements and considerations . 106.2.3 Representative mode of operation 116.2.4 Considerations for the test environment . 116.2.5 Determination of the

17、test environment 116.2.6 Approximate identification of HPC location(s) 116.2.7 Precise determination of HPC location(s) . 126.2.8 Suitability measurement(s) . 126.2.9 Data processing 136.2.10 Reference to ISO 146441 classification system 157 Documentation 157.1 General 157.2 Common documentation req

18、uirements . 157.3 Documentation for visual inspection . 167.4 Documentation for assessment of test environment 167.5 Documentation for classification measurement .178 Statement on cleanroom suitability 17Annex A (informative) Example for data processing deriving from measurements .19Annex B (informa

19、tive) Additional optional tests 23Bibliography .26Contents PageDIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)2Foreword .4European foreword This document (EN ISO 14644-14:2016) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments” in collaborati

20、on 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 April 2017, and conflicting national standard

21、s 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 held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Interna

22、l Regulations, the national standards organizations 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, Hungary, Iceland, Irel

23、and, 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 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any modification.

24、 DIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)3 ForewordISO (the International 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.

25、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, also take part in the work. ISO collaborates closely with the Internat

26、ional 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. In particular the different approval criteria needed for the differe

27、nt 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 elements of this document may be the subject of patent rights. ISO shall n

28、ot 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 (see www.iso.org/patents).Any trade name used in this document is in

29、formation 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 adherence to the World Trade Organization (WTO) principles in the Technical

30、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, published under the general title Cleanrooms and associated controlle

31、d environments, can be found on the ISO website.DIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)4 IntroductionCleanrooms and associated controlled environments provide for the control of contamination to levels appropriate for accomplishing contaminationsensitive activities. Products and process

32、es 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 part of ISO 14644 links the cleanroom classification of air cleanliness by particle concen

33、tration to the suitability of equipment for use in cleanrooms and associated controlled environments.DIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)5 1 ScopeThis part of ISO 14644 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipm

34、ent, components and tools) for use in cleanrooms 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

35、 guidelines or restrictions, appropriate adaptation 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

36、of equipment and materials; requirements on design 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; protocol

37、s and requirements for local safety regulations.2 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

38、of the referenced document (including any amendments) 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.3.1

39、cleanlinesscondition not exceeding a specified level of contaminationDIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)6 3.2cleanroomroom within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control

40、 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 cleanliness in

41、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, 3.1.13.3cleanr

42、oom 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 number concentrat

43、ion 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: Levels of other

44、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 a cleanroom o

45、r 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, 3.1.23.5deconta

46、minationreduction 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, t

47、ools, 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 parametersDIN EN ISO 14644-14:2017-01 EN ISO 14644-14:2016 (E)7 4 General outline of the assessmentCleanroom suitability assessm

48、ent has the following outline.a) Before the assessment can be executed, the customer and supplier shall agree upon the particle size range(s), with reference to air cleanliness by particle concentration, designated by ISO Class N as given in ISO 14644-1 and item to be tested including the modes of operation(s). Each selected mode of operation sha