DIN EN ISO 14644-2-2016 Cleanrooms and associated controlled environments - Part 2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle co.pdf

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1、May 2016 English price group 12No 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!%UVw“2505184www.din.deDIN

2、EN ISO 14644-2Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015);English version EN ISO 14644-2:2015,English translation of DIN EN ISO 14644-2:2016-05Reinrume und zu

3、gehrige Reinraumbereiche Teil 2: berwachung zum Nachweis der Reinraumleistung bezglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015);Englische Fassung EN ISO 14644-2:2015,Englische bersetzung von DIN EN ISO 14644-2:2016-05Salles propres et environnements matriss apparents Partie 2

4、: Surveillance du maintien des performances de la salle propre pour la propret particulaire de lair (ISO 14644-2:2015);Version anglaise EN ISO 14644-2:2015,Traduction anglaise de DIN EN ISO 14644-2:2016-05SupersedesDIN EN ISO 14644-2:2001-02www.beuth.deDocument comprises 21 pagesDTranslation by DIN-

5、Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.05.16 DIN EN ISO 14644-2:2016-05 2 A comma is used as the decimal marker. National foreword This document (EN ISO 14644-2:2015) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associat

6、ed controlled environments” in collaboration 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 Techn

7、ology), Working Committee NA 041-02-21 AA Reinraumtechnik (SpA CEN/TC 243 und ISO/TC 209). Amendments This standard differs from DIN EN ISO 14644-2:2001-02 as follows: a) the title of the standard has been changed to read “Monitoring to provide evidence of cleanroom performance related to air cleanl

8、iness by particle concentration”; b) the former Clause 4 “Demonstration of continued compliance” has been replaced; c) a new Clause 4 “Creating, implementing and maintaining a monitoring plan” and Clause 5 “Periodic classification of air cleanliness by particle concentration” have been included; d)

9、the former informative Annex B “Guidance on the influence of risk assessment on cleanroom or clean zone tests and monitoring” has been replaced by a new informative Annex B “Considerations for setting alert and action levels”; e) the standard has been adapted to DIN EN ISO 14644-1 which has also bee

10、n revised. Previous editions DIN EN ISO 14644-2: 2001-02 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14644-2 December 2015 ICS 13.040.35 Supersedes EN ISO 14644-2:2000English Version Cleanrooms and associated controlled environments -Part2: Monitoring to provide evidence of cleanroom pe

11、rformance related to air cleanliness by particle concentration (ISO 14644-2:2015) Salles propres et environnements matriss apparents -Partie 2: Surveillance du maintien des performances de la salle propre pour la propret particulaire de lair (ISO 14644-2:2015) Reinrume und zugehrige Reinraumbereiche

12、 - Teil 2: berwachung zum Nachweis der Reinraumleistung bezglich Luftreinheit anhand der Partikelkonzentration (ISO 14644-2:2015) This European Standard was approved by CEN on 27 November 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions f

13、or 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 Management Centre or to any CEN member. This European Standard exists in thr

14、ee 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 as the official versions. CEN members are the national standards bo

15、dies 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, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia,

16、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 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldw

17、ide for CEN national Members. Ref. No. EN ISO 14644-2:2015 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Creating, implementing and maintaining a monitoring plan 74.1 Principle 74.2 Risk assessment . 74.3 Monitoring plan 84.4 Calibration 84.5 Revi

18、ew and approval 94.6 Response to a deviation during monitoring 95 Periodic classification of air cleanliness by particle concentration . 9Annex A (informative) Matters to consider when developing a monitoring plan 10Annex B (informative) Considerations for setting alert and action levels . 14Bibliog

19、raphy .19Contents PageDIN EN ISO 14644-2:2016-05 EN ISO 14644-2:2015 (E) 2Foreword .4European foreword This document (EN ISO 14644-2:2015) has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments“ in collaboration with Technical Committee CEN/TC 243 “Cle

20、anroom 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 June 2016, and conflicting national standards shall be withdrawn at the latest by June 2

21、016. 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. This document supersedes EN ISO 14644-2:2000. According to the CEN-CENELEC Intern

22、al 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, Ire

23、land, 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 14644-2:2015 has been approved by CEN as EN ISO 14644-2:2015 without any modification.

24、DIN EN ISO 14644-2:2016-05 EN ISO 14644-2:2015 (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. Ea

25、ch 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 Internatio

26、nal 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 different

27、 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 not

28、 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 info

29、rmation 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 WTO principles in the Technical Barriers to Trade (TBT) see t

30、he following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled environments.This second edition cancels and replaces the first edition (ISO 14644-2:2000), which has been technically revised throughout.ISO 14644 co

31、nsists of the following parts, under the general title Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness by particle concentration Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration Part 3: T

32、est methods Part 4: Design, construction and start-up Part 5: Operations Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) Part 8: Classification of air cleanliness by chemical concentration (ACC) Part 9: Classification of surface cleanliness by particle conce

33、ntration Part 10: Classification of surface cleanliness by chemical concentrationAttention is also drawn to ISO 14698, Cleanrooms and associated controlled environments Bio-contamination control: Part 1: General principles and methods Part 2: Evaluation and interpretation of bio-contamination dataDI

34、N EN ISO 14644-2:2016-05 EN ISO 14644-2:2015 (E) 4 IntroductionThis revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with ISO 14644-1:2015, 5.1. The monitori

35、ng activity provides a continuing flow of data over time, thereby providing a more detailed view of the performance of the installation.Potential benefits gained from monitoring are faster response to adverse events and conditions, ability to develop trends from data over time, integration of data f

36、rom multiple instruments, enhanced knowledge of installation and process, which allows for more effective risk assessment, and improved control of operational costs and product losses.ISO 14644-2 specifies the requirements of a monitoring plan, based on risk assessment of the intended use. The data

37、obtained provide evidence of cleanroom or clean zone performance related to air cleanliness by particle concentration.In some circumstances, relevant regulatory agencies may impose supplementary policies, requirements or restrictions. In such situations, appropriate adaptations of the monitoring pro

38、cedures may be required. After a monitoring plan is initially established and implemented, it may be necessary to revise the plan when significant changes are made to the installation or process requirements. It is also prudent to conduct periodic reviews of a monitoring plan based on data obtained

39、and experience in use.DIN EN ISO 14644-2:2016-05 EN ISO 14644-2:2015 (E) 5 1 ScopeThis part of ISO 14644 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration, based upon parameters that measure or affect air

40、borne particle concentration.This part of ISO 14644 does not address condition monitoring of aspects such as vibration or general maintenance of the engineering systems. It does not provide for monitoring of particle populations that are outside the specified lower threshold particle-size range, 0,1

41、 m to 5 m. Concentrations of ultrafine particles (particles smaller than 0,1m) will be addressed in a separate standard.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, onl

42、y the edition cited applies. For undated references, the latest edition 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

43、purposes of this document, the terms and definitions given in ISO 14644-1 and the following apply:3.1testprocedure undertaken in accordance with a defined method to determine the performance of an installation or an element thereof3.2monitoringobservations made by measurement in accordance with a de

44、fined method and plan to provide evidence of the performance of an installationNote 1 to entry: Monitoring may be continuous, sequential or periodic; and if periodic, the frequency shall be specified.Note 2 to entry: This information may be used to detect trends in operational state and to provide p

45、rocess support.3.3action levellevel of a parameter set by the user which, when exceeded, requires immediate intervention, including investigation of cause, and corrective actionDIN EN ISO 14644-2:2016-05 EN ISO 14644-2:2015 (E) 6 3.4alert levellevel of a parameter set by the user giving early warnin

46、g of a drift from normal conditions, which, when exceeded, should result in increased attention or corrective action4 Creating, implementing and maintaining a monitoring plan4.1 PrincipleIn order to gain assurance that a cleanroom or clean zone is performing adequately by delivering the required con

47、trol of air cleanliness by particle concentration, a monitoring plan shall be created, implemented and maintained.A monitoring plan shall take into account the level of air cleanliness required, critical locations and performance attributes of the cleanroom or clean zone that affect the performance

48、of the installation. The following steps shall be included in the creation, implementation and maintenance of the monitoring plan: use appropriate risk assessment tools to understand, evaluate and document the risk of adverse contamination events; develop a written monitoring plan; review and approve the plan; implement the plan by performing the monitoring; analyse the data derived from the monitoring activity, undertake trend analysis