EN ISO 14644-4-2001 en Cleanrooms and associated controlled environments - Part 4 Design construction and start-up《洁净室和相关控制环境 第4部分 设计 建造和启用 ISO 14644-4-2001》.pdf

1、BRITISH STANDARD BS EN ISO 14644-4:2001 Incorporating Corrigendum No.1 Cleanrooms and associated controlled environments Part 4: Design, construction and start-up The European Standard EN ISO 14644-4:2001 has the status of a British Standard ICS 13.040.30 BS EN ISO 14644-4:2001 This British Standard

2、, having been prepared under the direction of the Sector Committee for Materials and Chemicals, was published under the authority of the Standards Committee and comes into effect on 15 September 2001 BSI 1 May 2003 ISBN 0 580 37985 X National foreword This British Standard is the official English la

3、nguage version of EN ISO 14644-4:2001. It is identical with ISO 14644-4:2001. It supersedes BS 5295-2:1989 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee LBI/30, Cleanroom technology, which has the responsibility to: A list of organizations represent

4、ed on this committee can be obtained on request to its secretary. This British Standard is one of a series, the other parts of BS EN ISO 14644 being as follows: Part 1: Classification of air cleanliness; Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

5、; Part 3: Metrology and test methods; Part 5: Operations; Part 6: Terms and definitions; Part 7: Separative enclosures (clean airhoods, gloveboxes, isolators, mini-environments); Part 8: Molecular contamination. Parts 1 and 2 have been published, while the numbering and titles of parts 3 and 5 to 8

6、were provisional at the time of publication of part 4. Attention is also drawn to BS 5295 Parts 0 and 3 and PD 6609, all updated in 2000, which will remain current documents until further Parts of BS EN ISO 14644 are published. Cross-references The British Standards which implement international or

7、European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to inclu

8、de all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee any enquiries on the int

9、erpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO tit

10、le page, pages ii to v, a blank page, pages 1 to 51, the Annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 14472 Corrigendum No. 1 1 May 200

11、3 Replacing the EN ISO foreword page and the Annex ZA pageEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO146444 April2001 ICS13.040.30 Englishversion CleanroomsandassociatedcontrolledenvironmentsPart4: Design,constructionandstartup(ISO146444:2001) Sallespropresetenvironnementsmatrissapparents P

12、artie4:Conception,constructionetmiseen fonctionnement(ISO146444:2001) ReinrumeundzugehrigeReinraumbereicheTeil4: Planung,AusfhrungundErstInbetriebnahme(ISO14644 4:2001) ThisEuropeanStandardwasapprovedbyCENon1April2001. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatethec

13、onditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German)

14、.Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Ita

15、ly,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCEN

16、nationalMembers. Ref.No.ENISO146444:2001EgaP2e INESO414464:0210 CORRECTED20030326 Foreword ThetextoftheInternationalStandardISO146444:2001hasbeenpreparedbyTechnical CommitteeISO/TC209“Cleanroomsandassociatedcontrolledenvironments“in collaborationwithTechnicalCommitteeCEN/TC243“Cleanroomtechnology“,t

17、hesecretariat ofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbyOctober2001,andconflictingnational standardsshallbewithdrawnatthelatestbyOctober2001. AccordingtotheCEN/CENELECInternalRegulations,thenatio

18、nalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom. Endorsementnotice ThetextoftheInte

19、rnationalStandardISO146444:2001wasapprovedbyCENasa EuropeanStandardwithoutanymodification. NOTE:NormativereferencestoInternationalStandardsarelistedinannexZA(normative). ENISO146444:2001Reference number ISO 14644-4:2001(E) INTERNATIONAL STANDARD ISO 14644-4 First edition 2001-04-01 Cleanrooms and as

20、sociated controlled environments Part 4: Design, construction and start-up Salles propres et environnements matriss apparents Partie 4: Conception, construction et mise en fonctionnementii ISO -446414:(1002E)iii Contents Foreword.iv Introduction.v 1 Scope 1 2 Normative references 1 3 Terms and defin

21、itions .2 4 Requirements.3 5 Planning and design4 5.1 Planning procedure .4 5.2 Design .5 6 Construction and start-up.5 7 Testing and approval.6 7.1 General6 7.2 Construction approval 6 7.3 Functional approval.6 7.4 Operational approval.6 8 Documentation.6 8.1 General6 8.2 Record of an installation.

22、6 8.3 Operational instructions .6 8.4 Instructions for performance monitoring7 8.5 Maintenance instructions .7 8.6 Maintenance record.7 8.7 Record of operation and maintenance training8 Annex A (informative) Control and segregation concepts9 Annex B (informative) Classification examples .16 Annex C

23、(informative) Approval of an installation.19 Annex D (informative) Layout of an installation.23 Annex E (informative) Construction and materials27 Annex F (informative) Environmental control of cleanrooms 32 Annex G (informative) Control of air cleanliness.35 Annex H (informative) Additional specifi

24、cation of requirements to be agreed upon between purchaser/user and designer/supplier 37 Bibliography50 ENISO146444:2001PD 62762:001 1002-70 ISB i Annex ZA (normative) Normative references to international publications with their relevant European publications.52ISO -446414:(1002E) iv Foreword ISO (

25、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 body interested in a subject for which a technical commi

26、ttee 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 Electrotechnical Commission (IEC) on all matters of electrotec

27、hnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approv

28、al by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 14644 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 14644-4

29、was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments. ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments: Part 1: Classification of air cleanliness Part 2: Specifications for testing and mo

30、nitoring to prove continued compliance with ISO 14644-1 Part 3: Metrology and test methods Part 4: Design, construction and start-up Part 5: Operations Part 6: Vocabulary Part 7: Separative enclosures (clean air hoods, glove boxes, isolators, mini-environments) Users should note that the titles list

31、ed for parts 3 and 5 to 7 are working titles at the time of the release of part 4. In the event that one or more of these parts are deleted from the work programme, the remaining parts may be renumbered. Annexes A to H of this part of ISO 14644 are for information only. ENISO146444:2001ISO -446414:(

32、1002E)v Introduction Cleanrooms and associated controlled environments provide for the control of airborne particulate contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of airborne contamination include thos

33、e in such industries as aerospace, microelectronics, pharmaceuticals, medical devices and healthcare. This part of ISO 14644 specifies the requirements for the design and construction of cleanroom facilities. It is intended for use by purchasers, suppliers and designers of cleanroom installations an

34、d provides a check list of important parameters of performance. Construction guidance is provided, including requirements for start-up and qualification. Basic elements of design and construction needed to ensure continued satisfactory operation are identified through the consideration of relevant a

35、spects of operation and maintenance. This part of ISO 14644 is one of a series of standards concerned with cleanrooms and associated subjects. Many factors besides design, construction and start-up should be considered in the operation and control of cleanrooms and other controlled environments. These are covered in some detail in other International Standards prepared by ISO/TC 209. ENISO146444:2001blank ENISO146444:2001