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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 ? Licensed Copy: sheffieldun sheffieldun, na
2、, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 14644-4:2001 This British Standard, 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 Septem
3、ber 2001 BSI 1 May 2003 ISBN 0 580 37985 X National foreword This British Standard is the official English language 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 It supersedes BS 5295-2:1989 which is withdrawn.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 Technic
4、al Committee LBI/30, Cleanroom technology, which has the responsibility to: A list of organizations represented 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
5、cleanliness; Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1; 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: Mole
6、cular contamination. Parts 1 and 2 have been published, while the numbering and titles of parts 3 and 5 to 8 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 Par
7、ts of BS EN ISO 14644 are published. Cross-references The British Standards which implement international or 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” facili
8、ty of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include 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.
9、 aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, 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
10、 comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title 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
11、was last issued. Amendments issued since publication Amd. No. DateComments 14472 Corrigendum No. 1 1 May 2003Replacing the EN ISO foreword page and the Annex ZA page Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUR
12、OPENNE EUROPISCHE NORM EN ISO 14644-4 April 2001 ICS 13.040.30 English version Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001) Salles propres et environnements matriss apparents - Partie 4: Conception, construction et mise en fonctionn
13、ement (ISO 14644-4:2001) Reinrume und zugehrige Reinraumbereiche - Teil 4: Planung, Ausfhrung und Erst-Inbetriebnahme (ISO 14644- 4:2001) This European Standard was approved by CEN on 1 April 2001. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditio
14、ns 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 Management Centre or to any CEN member. This European Standard exists in three offic
15、ial 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Bel
16、gium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre:
17、rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14644-4:2001 E Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI gaP2 e I NESO 41-
18、4464:0210 CORRECTED 2003-03-26 Foreword The text of the International Standard ISO 14644-4:2001 has been prepared by Technical Committee ISO/TC 209 “Cleanrooms and associated controlled environments“ in collaboration with Technical Committee CEN/TC 243 “Cleanroom technology“, the secretariat of whic
19、h 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 October 2001, and conflicting national standards shall be withdrawn at the latest by October 2001. According to the CEN/CENELEC In
20、ternal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerla
21、nd and the United Kingdom. Endorsement notice The text of the International Standard ISO 14644-4:2001 was approved by CEN as a European Standard without any modification. NOTE: Normative references to International Standards are listed in annex ZA (normative). EN ISO 146444:2001 Licensed Copy: sheff
22、ieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 14644-4:2001(E) INTERNATIONAL STANDARD ISO 14644-4 First edition 2001-04-01 Cleanrooms and associated controlled environments Part 4: Design, construction and start-up Salles propres et enviro
23、nnements matriss apparents Partie 4: Conception, construction et mise en fonctionnement Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c)
24、 BSI ISO -446414:(1002E) iii Contents Foreword.iv Introduction.v 1Scope 1 2Normative references1 3Terms and definitions .2 4Requirements.3 5Planning and design4 5.1Planning procedure.4 5.2Design.5 6Construction and start-up.5 7Testing and approval.6 7.1General6 7.2Construction approval 6 7.3Function
25、al approval.6 7.4Operational approval.6 8Documentation.6 8.1General6 8.2Record of an installation.6 8.3Operational instructions .6 8.4Instructions for performance monitoring7 8.5Maintenance instructions .7 8.6Maintenance record.7 8.7Record of operation and maintenance training8 Annex A (informative)
26、 Control and segregation concepts9 Annex B (informative) Classification examples.16 Annex C (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
27、Annex G (informative) Control of air cleanliness.35 Annex H (informative) Additional specification of requirements to be agreed upon between purchaser/user and designer/supplier 37 Bibliography50 EN ISO 146444:2001 PD 62762:001 1002-70 ISB i Annex ZA (normative) Normative references to international
28、 publications with their relevant European publications.52 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -446414:(1002E) iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standar
29、ds 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 has been established has the right to be represented on that committee. International organi
30、zations, 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 standardization. International Standards are drafted in accordance with the rules given in
31、 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 approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility th
32、at 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 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled environments
33、. 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 monitoring to prove continued compliance with ISO 14644-1 ?Part 3: Metrology and test methods ?Pa
34、rt 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 listed for parts 3 and 5 to 7 are working titles at the time of the release of part 4. In the
35、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. EN ISO 146444:2001 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (
36、c) BSI ISO -446414:(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 controlofairborne contami
37、nationincludethoseinsuchindustriesasaerospace,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 insta
38、llations and 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
39、 relevant aspects 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 enviro
40、nments. These are covered in some detail in other International Standards prepared by ISO/TC 209. EN ISO 146444:2001 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank EN ISO 146444:2001 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov
41、 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADRISO -446414:(1002E) ISO 1002 All rights rsedevre1 Cleanrooms and associated controlled environments Part 4: Design, construction and start-up 1Scope This part of ISO 14644 specifies requirements for the design and construc
42、tion of cleanroom installations but does not prescribe specific technological or contractual means to meet these requirements. It is intended for use by purchasers, suppliers and designers of cleanroom installations and provides a checklist of important parameters of performance. Construction guidan
43、ce 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 aspects of operation and maintenance. NOTEFurther guidance in respect of the above r
44、equirements is given in annexes A to H. Other parts of ISO 14644 may provide complementary information. Application of this part of ISO 14644 is restricted in the following: ?user requirements are represented by purchaser or specifier; ?specific processes to be accommodated in the cleanroom installa
45、tion are not specified; ?fire and safety regulations are not considered specifically; the appropriate national and local requirements should be respected; ?process media and utility services are only considered with respect to their routing between and in the different zones of cleanliness; ?regardi
46、nginitialoperationandmaintenance,onlycleanroomconstruction-specificrequirementsare considered. 2Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 14644. For dated references, subsequent amendment
47、s to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 14644 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of t
48、he normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 14644-1:1999, Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness. ISO 14644-2:2000, Cleanrooms and associated controlled envir
49、onments Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1. 1 1002:444641 OSI NEEN ISO 146444:2001 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:57:10 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO -446414:(1002E) 2 ISO 1002 All rights rsedevre ISO 14644-3:1?, Cleanrooms and associated controlled environments Part 3: Metrology and test methods. ISO 14698-1: 1), Cleanroomsandassociatedcontrolledenvironments Bioconta