EN ISO 14644-2-2015 en Cleanrooms and associated controlled environments - Part 2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle con.pdf

1、BSI Standards PublicationBS EN ISO 14644-2:2015Cleanrooms and associatedcontrolled environmentsPart 2: Monitoring to provide evidenceof cleanroom performance related to aircleanliness by particle concentration (ISO14644-2:2015)BS EN ISO 14644-2:2015 BRITISH STANDARDNational forewordThis British Stan

2、dard is the UK implementation of EN ISO 14644-2:2015. It supersedes BS EN ISO 14644-2:2000 which is withdrawn.BS EN ISO 14644-2:2000 gave normative information on the frequency of testing of cleanroom and clean zones to give evidence of the continued compliance with the cleanliness classes given in

3、BS EN ISO 14644-1. However, when revising BS EN ISO 14644-2 the guidance in the standard became narrower and concentrated on continuous monitoring. During the revision process of BS EN ISO 14644-2 the UK committee supported the revision work and proposed an informative annex to provide guidance on t

4、he frequency of classification testing and testing of other performance attributes. During the working group discussions these proposals were considered to be too significant a change to be included, therefore comprehensive guidance on the frequency of testing of cleanrooms and clean zones was exclu

5、ded from the standard. National Annex NA of this standard has been produced to supplement the revised BS EN ISO 14644-2:2015 and provide cleanroom users in the UK, many of whom do not need to continuously monitor their cleanrooms with automated systems, with guidance on the frequency of testing airb

6、orne particle concentrations, pressure differential monitoring, filter leak testing, air flow volumes and velocities etc. This additional information does not conflict with the requirements of the new BS EN ISO 14644-2:2015.The UK participation in its preparation was entrusted to Technical Committee

7、 LBI/30, Cleanroom technology.A list of 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 Institutio

8、n 2016. Published by BSI Standards Limited 2016ISBN 978 0 580 57301 9ICS 13.040.35Compliance 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 31 January 2016.Amendments/corr

9、igenda issued since publicationDate Text affectedEUROPEAN 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 - Part 2: Monitoring to provide evidence of cleanroom performa

10、nce 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 - Te

11、il 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 for gi

12、ving 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 three of

13、ficial 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 bodies

14、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, Spain

15、, 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 worldwide f

16、or CEN national Members. Ref. No. EN ISO 14644-2:2015 EEN ISO 14644-2:2015 (E) 3 European 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 “Cleanro

17、om 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 2016.

18、 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 Internal R

19、egulations, 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, Ireland

20、, 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. ISO

21、14644-2:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Creating, implementing and maintaining a monitoring plan 24.1 Principle 24.2 Risk assessment . 24.3 Monitoring plan 34.4 Calibration 34.5 Review and approval 44.6 Response to a deviation during mo

22、nitoring 45 Periodic classification of air cleanliness by particle concentration . 4Annex A (informative) Matters to consider when developing a monitoring plan . 5Annex B (informative) Considerations for setting alert and action levels 9Bibliography .14 ISO 2015 All rights reserved iiiContents PageB

23、S EN ISO 14644-2:2015ISO 14644-2:2015(E)ii ISO 2015 All rights reserved ISO 14644-2:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Creating, implementing and maintaining a monitoring plan 24.1 Principle 24.2 Risk assessment . 24.3 Monitoring plan 34.4

24、 Calibration 34.5 Review and approval 44.6 Response to a deviation during monitoring 45 Periodic classification of air cleanliness by particle concentration . 4Annex A (informative) Matters to consider when developing a monitoring plan . 5Annex B (informative) Considerations for setting alert and ac

25、tion levels 9Bibliography .14 ISO 2015 All rights reserved iiiContents PageBS EN ISO 14644-2:2015ISO 14644-2:2015(E)iii ISO 2015 All rights rNational Annex NA (informative) Guidance on maximum time intervals for periodic testing of cleanrooms and clean zones 15ISO 14644-2:2015(E)ForewordISO (the Int

26、ernational 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. Each member body interested in a subject for which a technical committee ha

27、s 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical

28、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 types of ISO documents should be noted. This document was drafted in acc

29、ordance 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 be held responsible for identifying any or all such patent rights. Detai

30、ls 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 information given for the convenience of users and does not constitute an end

31、orsement.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 the following URL: Foreword - Supplementary informationThe committee respo

32、nsible 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 consists of the following parts, under the general title Cleanrooms and ass

33、ociated 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: Test methods Part 4: Design, construction and start-up Part 5: Operations

34、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 concentration Part 10: Classification of surface cleanliness by chemical conce

35、ntrationAttention 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 dataiv ISO 2015 All rights reserved ISO 14644-2:2015(E)IntroductionThis revisio

36、n 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 monitoring activity provides a continuing flow of data over time, thereby providing

37、 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 from multiple instruments, enhanced knowledge of installation and process, w

38、hich 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 obtained provide evidence of cleanroom or clean zone performance related to

39、 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 procedures may be required. After a monitoring plan is initially established a

40、nd 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 and experience in use. ISO 2015 All rights reserved vBS EN ISO 14644-2:2015

41、iv ISO 2015 All rights r ISO 14644-2:2015(E)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. Each member

42、 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 International Elect

43、rotechnical 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 types of

44、 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 be held

45、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 information g

46、iven 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 the follow

47、ing 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 consists of

48、 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: Test 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