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SLOVENSKI STANDARD
01-marec-2023
Nadomešča:
SIST EN ISO 14644-4:2002
Čiste sobe in podobna nadzorovana okolja - 4. del: Načrtovanje, izdelava in
začetek obratovanja (ISO 14644-4:2022)
Cleanrooms and associated controlled environments - Part 4: Design, construction and
start-up (ISO 14644-4:2022)
Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-
Inbetriebnahme (ISO 14644-4:2022)
Salles propres et environnements maîtrisés apparentés - Partie 4: Conception,
construction et mise en service (ISO 14644-4:2022)
Ta slovenski standard je istoveten z: EN ISO 14644-4:2022
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 14644-4
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-4:2001
English Version
Cleanrooms and associated controlled environments - Part
4: Design, construction and start-up (ISO 14644-4:2022)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 4:
- Partie 4: Conception, construction et mise en service Planung, Ausführung und Erst-Inbetriebnahme (ISO
(ISO 14644-4:2022) 14644-4:2022)
This European Standard was approved by CEN on 14 November 2022.
CEN members are bound to 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-CENELEC 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-4:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-4:2022) 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 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 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14644-4:2001.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal 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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 14644-4:2022 has been approved by CEN as EN ISO 14644-4:2022 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-4
Second edition
2022-11
Cleanrooms and associated controlled
environments —
Part 4:
Design, construction and start-up
Salles propres et environnements maîtrisés apparentés —
Partie 4: Conception, construction et mise en service
Reference number
ISO 14644-4:2022(E)
ISO 14644-4:2022(E)
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: [email protected]
Website: www.iso.org
Published in Switzerland
ii
ISO 14644-4:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 S c op e . 1
2 Nor m at i ve r ef er enc e s . 1
3 Terms and definitions . 1
3.1 G eneral . 2
3 . 2 I n s t a l l at ion . 5
4 Abbr ev i at ed t er m s . 5
5 G ener a l . 6
6 R e qu i r ement s . 7
6.1 C leanroom requirements . 7
6.2 O ther requirements . 9
6 . 3 D o c u ment at ion . 9
7 D e sig n . 9
7.1 G eneral . 9
7. 2 C onc ep t u a l de s i g n . . . 10
7. 3 Ba s ic de s i g n . 10
7.4 D e t a i le d de s i g n . 11
7. 5 C ha n g e ma nag ement . 11
8 C on s t r uc t ion .12
8.1 General .12
8 . 2 C on s t r uc t ion pl a n .12
8.2.1 General .12
8 . 2. 2 S c he du le . 12
8.2.3 Quality plan .12
8.2.4 C lean build protocol .12
8.3 Construction verification .13
8 .4 D o c u ment at ion . 13
9 S t a r t-up .13
9.1 G eneral .13
9. 2 C om m i s s ion i n g . 14
9.2.1 G eneral . 14
9.2.2 S etting to work . 14
9.2.3 Functional and performance verifications . 14
9. 3 Tr a in in g . 14
9.4 Ha ndover . 14
9. 5 D o c u ment at ion . 14
9. 5 .1 C om m i s s ion i n g do c u ment at ion . 14
9. 5 . 2 Per f or m a nc e -mon it or i n g i n s t r uc t ion s . 15
9. 5 . 3 M a i nt en a nc e i n s t r uc t ion s . 15
9. 5 .4 M a i nt en a nce r e cor d .
...