EN ISO 14644-4:2022

Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)

This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE       Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
—    specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
—    fire and safety regulations;
—    ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.

Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-Inbetriebnahme (ISO 14644-4:2022)

Dieses Dokument legt den Prozess der Erstellung eines Reinraums von den Anforderungen über Planung und Ausführung bis zur Erst-Inbetriebnahme fest. Es ist für neue sowie modernisierte oder umgebaute Reinraumanlagen anwendbar. Es schreibt keine spezifischen technischen oder vertraglichen Maßnahmen vor, um diese Anforderungen zu erreichen. Es ist für Anwender, Projektmanager, Planer, Auftraggeber, Lieferanten, Erbauer und Leistungsprüfer von Reinraumanlagen gedacht. Der wichtigste Aspekt bei Reinräumen ist die Konzentration der luftgetragenen Partikel. Für die Anforderungen, die Planung, die Ausführung und die Erst-Inbetriebnahme werden detaillierte Prüflisten angegeben, die wichtige zu berücksichtigende Leistungsparameter umfassen. Es werden Planungsansätze bezüglich des Energiemanagements zur Unterstützung einer energieeffizienten Reinraumplanung bestimmt. Es wird eine Anleitung zur Ausführung einschließlich der Anforderungen für die Erst-Inbetriebnahme und Verifizierung gegeben. Ein grundlegender Bestandteil dieses Dokuments ist die Betrachtung der Aspekte (einschließlich Instandhaltung), die helfen werden, einen fortlaufenden und zufriedenstellenden Betrieb während der gesamten Nutzungsdauer des Reinraums sicherstellen.
ANMERKUNG   Weitere Anleitungen sind in Anhang A bis Anhang D enthalten. ISO 14644 1, ISO 14644 2, ISO 14644 8, ISO 14644 9, ISO 14644 10, ISO 14644 12 und ISO 14644 17 enthalten ergänzende Informationen. ISO 14644 7 bietet eine Anleitung zu Planung, Ausführung und den Anforderungen an SD-Module (Reinlufthauben, Handschuhboxen, Isolatoren und Minienvironments).
Die folgenden Themen werden in diesem Dokument angesprochen, aber nicht behandelt:
   spezielle betriebliche Aktivitäten, zu integrierende Prozesse und Prozesseinrichtungen in der Reinraumanlage;
   Brandschutz- und Sicherheitsvorschriften;
   laufende Betriebs-, Reinigungs- und Instandhaltungsaktivitäten, die in ISO 14644 5 behandelt werden.

Salles propres et environnements maîtrisés apparentés - Partie 4: Conception, construction et mise en service (ISO 14644-4:2022)

Le présent document spécifie le processus de création d’une salle propre allant des exigences jusqu’à la conception, la construction et la mise en service. Il s’applique aux installations de salles propres nouvelles, rénovées ou modifiées. Il ne prescrit pas de moyens technologiques ou contractuels spécifiques pour satisfaire à ces exigences. Il est destiné aux utilisateurs, prescripteurs, concepteurs, acheteurs, fournisseurs, constructeurs et vérificateurs des performances d’installations de salles propres. La principale considération en matière de propreté est la concentration particulaire de l’air. Des listes de contrôle détaillées sont fournies pour les différentes étapes: les exigences, la conception, la construction et la mise en service. Celles-ci comprennent les paramètres de performance importants à prendre en compte. Des approches de conception basées sur le management de l’énergie sont identifiées afin de permettre une conception de salle propre efficace sur le plan énergétique. Des recommandations en matière de construction sont fournies, incluant des exigences pour la mise en service et la vérification. L’un des principaux éléments du présent document concerne les aspects à prendre en considération, maintenance comprise, qui sont destinés à garantir un fonctionnement constant satisfaisant pendant tout le cycle de vie de la salle propre.
NOTE            D’autres recommandations sont données dans les Annexes A à D. L’ISO 14644-1, l’ISO 14644-2, l’ISO 14644-8, l’ISO 14644-9, l’ISO 14644-10, l’ISO 14644-12 et l’ISO 14644-17 fournissent des informations complémentaires. L’ISO 14644-7 propose des recommandations relatives à la conception, à la construction et aux exigences spécifiques des dispositifs séparatifs (postes à air propre, boîtes à gants, isolateurs et mini‑environnements).
Les sujets suivants sont mentionnés, mais non traités dans le présent document:
—     des activités opérationnelles spécifiques, des procédés spécifiques et équipements de procédé à héberger dans l’installation de salle propre;
—     réglementations de sécurité et de protection incendie;
—     activités courantes d’exploitation, de nettoyage et de maintenance, traitées dans l’ISO14644-5.

Čiste sobe in podobna nadzorovana okolja - 4. del: Načrtovanje, izdelava in začetek obratovanja (ISO 14644-4:2022)

Ta dokument določa postopek vzpostavitve čiste sobe od zahtev do načrtovanja, izdelave in začetka obratovanja. Uporablja se za nove, prenovljene in spremenjene objekte s čistimi sobami. Ne predpisuje določenih tehnoloških ali pogodbenih načinov za doseganje teh zahtev. Namenjen je uporabnikom, specifikatorjem, načrtovalcem, kupcem, dobaviteljem, gradbenikom in preveriteljem učinkovitosti objektov s čistimi sobami. Najpomembnejši vidik čistosti je koncentracija lebdečih delcev. Na voljo so podrobni kontrolni seznami za zahteve, načrtovanje, izdelavo in začetek obratovanja, vključno s pomembnimi parametri delovanja, ki jih je treba upoštevati. Opredeljeni so pristopi za načrtovanje upravljanja z energijo, ki podpirajo energetsko učinkovito zasnovo čiste sobe. Podane so smernice glede izdelave, vključno z zahtevami za začetek obratovanja in preverjanje. Osnovni element tega dokumenta je upoštevanje vidikov, vključno z vzdrževanjem, ki bodo pomagali zagotoviti nadaljnje zadovoljivo delovanje v celotnem življenjskem ciklu čiste sobe.
OPOMBA: Nadaljnja navodila so v dodatkih A do D.V standardih ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 in ISO 14644-17 so podane dodatne informacije. Standard ISO 14644-7 vsebuje navodila glede načrtovanja, izdelave in zahtev za ločevalne naprave (nape za čist zrak, predali za rokavice, izolatorji in mini okolja).
Naslednje vsebine so omenjene, vendar v tem dokumentu niso obravnavane:
– specifične operativne dejavnosti, procese, ki jih je treba prilagoditi, in procesno opremo v objektih s čistimi sobami;
– predpisi o požarni varnosti;
– obstoječe operativne dejavnosti ter dejavnosti čiščenja in vzdrževanja, ki so zajete v standardu ISO 14644-5.

General Information

• Status: Published
• Publication Date: 06-Dec-2022
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 07-Dec-2022
• Completion Date: 07-Dec-2022
• Ref Project: SIST EN ISO 14644-4:2023 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)

Relations

• Replaces: EN ISO 14644-4:2001 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
• Effective Date: 14-Nov-2018

Standards Content (Sample)

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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
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 .
...