SIST EN ISO 14644-4:2023

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 Gestaltung 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 Gestaltung, den Bau und die Erst-Inbetriebnahme werden detaillierte Prüflisten angegeben, die wichtige zu berücksichtigende Leistungsparameter umfassen. Es werden Gestaltungsansätze 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 den Anhängen A bis 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 Gestaltung, Konstruktion 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
• Public Enquiry End Date: 30-Dec-2021
• Publication Date: 29-Jan-2023
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Dec-2022
• Due Date: 19-Feb-2023
• Completion Date: 30-Jan-2023
• Ref Project: EN ISO 14644-4:2022 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)

Relations

• Replaces: SIST EN ISO 14644-4:2002 - Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2001)
• Effective Date: 01-Feb-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-4:2023
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
SIST EN ISO 14644-4:2023 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14644-4:2023

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SIST EN ISO 14644-4:2023


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.

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SIST EN ISO 14644-4:2023
EN ISO 14644-4:2022 (E)
Contents Page
European foreword . 3

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SIST EN ISO 14644-4:2023
EN ISO 14644-4:2022 (E)
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.


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SIST EN ISO 14644-4:2023

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SIST EN ISO 14644-4:2023
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 2022

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SIST EN ISO 14644-4:2023
ISO 14644-4:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 14644-4:2023
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 . 15
9.5.5 R ecord of training .15
Annex A (informative) Guidance on requirements .16
Annex B (informative) Guidance on design .24
Annex C (informative) Guidance on construction .45
Annex D (informative) Guidance on start-up .51
Bibliography .56
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SIST EN ISO 14644-4:2023
ISO 14644-4:2022(E)
Foreword
ISO (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
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 Electrotechnical 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 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 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 given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 243, Cleanroom technology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO 14644-4:2001), which has been
technically revised.
The main changes are as follows:
— normative content has been extended;
— the process of gathering and defining requirements has been added;
— the scope has been extended from classified cleanrooms to include additional cleanliness attributes;
— the entire text has been revised or clarified to aid its application.
A list of all parts in the ISO 14644 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 14644-4:2023
ISO 14644-4:2022(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination and, if relevant, other forms of contamination, to levels appropriate for accomplishing
contamination-sensitive activities. Products and processes that benefit from the control of airborne
contamination include those in such industries as aerospace, microelectronics, pharmaceuticals,
medical devices, food and research and development laboratories and some applications in healthcare.
Cleanrooms and associated controlled environments are classified for air cleanliness by particle
concentration (ISO 14644-1). Cleanliness attributes relating to chemicals, nanoscale particles and
viable particles (microorganisms), as well as cleanliness of surfaces, can also be considered.
This document is one of the series of International Standards concerned with cleanrooms and associated
controlled environments prepared by ISO/TC 209.
This document provides guidance for the design, construction and start-up of cleanrooms, both new
and those undergoing modification or refurbishment. In this edition, a more structured approach
is provided with separate normative sections on requirements, design, construction and start-up,
supported by four corresponding informative annexes.
For this edition, key recommendations and considerations include:
a) A structured approach with a logical sequential flow through the design, construction and start-
up stages. There will normally be reviews and iterations of the requirements, contamination
control concepts, layouts and other considerations. The final design should be reviewed against the
requirements before construction commences and when construction is complete. The operation
and performance are verified against the requirements during start-up.
b) Inclusion of other cleanliness attributes. The ISO 14644 series has parts that deal with other
cleanliness attributes, namely chemicals, nanoscale particles, macro-particles and, in ISO 14698,
viable particles (microorganisms), as well as cleanliness of surfaces. These other attributes should
be considered if relevant, bearing in mind that the primary requirement for a cleanroom or clean
zone is that it meets a classification by airborne particle concentration according to ISO 14644-1.
c) Importance of a contamination risk assessment. Assessments should be carried out to better
understand the contamination risk and its impact on the process and product and to identify the
critical control points (locations) in the cleanroom or clean zone.
d) A clear statement of requirements, namely everything needed for input into the design, including
the purpose of the cleanroom and the acceptance criteria for performance parameters. This is
critical and should be documented prior to the start of the design process.
e) Ventilation effectiveness. This revision focuses on the importance of ventilation effectiveness
through control of air-flow patterns and clean-up recovery rates. Two measures are identified: air
change effectiveness (ACE) and contaminant removal effectiveness (CRE).
f) Using air supply rate for calculations of contaminant dilution and removal. This will make it possible
to achieve energy-efficient cleanrooms while achieving the required level of air cleanliness.
g) Energy efficiency and life cycle considerations. Energy efficiency in cleanrooms is very important
and is covered by ISO 14644-16.
h) A clean build protocol. This is included to minimize contamination during construction of the
cleanroom.
Information directly relevant to cleanrooms and associated controlled environments is included in the
informative annexes. Supporting information is given in the Bibliography.
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SIST EN ISO 14644-4:2023
INTERNATIONAL STANDARD ISO 14644-4:2022(E)
Cleanrooms and associated controlled environments —
Part 4:
Design, construction and start-up
1 S cope
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.
2 Normat ive references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
ISO 14644-16, Cleanrooms and associated controlled environments — Part 16: Energy efficiency in
cleanrooms and separative devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
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SIST EN ISO 14644-4:2023
ISO 14644-4:2022(E)
3.1 General
3.1.1
air change effectiveness
ACE
ratio between the recovery rate at a location or locations in a cleanroom (3.1.4) and the overall recovery
rate of the cleanroom after a contamination event
Note 1 to entry: The recovery rate is defined and measured in accordance with ISO 14644-3.
[SOURCE: ISO 14644-16:2019, 3.2.7]
3.1.2
classification
method of assessing level of cleanliness against a specification for a cleanroom or clean zone
Note 1 to entry: Levels should be expressed in terms of an ISO Class, which represents maximum allowable
concentrations of particles in a unit volume of air.
[SOURCE: ISO 14644-1:2015, 3.1.4]
3.1.3
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: ISO 14644-15:2017, 3.5]
3.1.4
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes, such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations, might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.1.5
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes, such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations, might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
Note 4 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
[SOURCE: ISO 14644-1:2015, 3.1.2]
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SIST EN ISO 14644-4:2023
ISO 14644-4:2022(E)
3.1.6
commissioning
planned and documented series of inspections, adjustments, measurements, tests and verifications
carried out systematically to set the installation into correct technical operation as specified
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of testing
other forms of determination, such as performing alternative calculations or reviewing documents
3.1.7
contaminant
particle, chemical or microorganism that adversely affects the product or process
3.1.8
contaminant removal effectiveness
CRE
ratio of particle concentration in the air leaving the cleanroom to the average of particle concentration
in the working plane of the cleanroom, when particles entering from filtered supply air are ignored
Note 1 to entry: If the air leaves the cleanroom at more than one point then the weighted average of the particle
concentrations based on the relative flowrates can be used.
Note 2 to entry: The number and positioning of the sampling locations for determining the average particle
concentration in the wor
...

SLOVENSKI STANDARD
oSIST prEN ISO 14644-4:2021
01-december-2021
Čiste sobe in podobna nadzorovana okolja - 4. del: Konstruiranje, izdelava in
zagon (ISO/DIS 14644-4:2021)
Cleanrooms and associated controlled environments - Part 4: Design, construction and
start-up (ISO/DIS 14644-4:2021)
Reinräume und zugehörige Reinraumbereiche - Teil 4: Planung, Ausführung und Erst-
Inbetriebnahme (ISO/DIS 14644 4:2021)
Salles propres et environnements maîtrisés apparentés - Partie 4 : Conception,
construction et mise en fonctionnement (ISO/DIS 14644-4:2021)
Ta slovenski standard je istoveten z: prEN ISO 14644
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-4:2021 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 14644-4:2021

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oSIST prEN ISO 14644-4:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-4
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-10-11 2022-01-03
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 fonctionnement
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-4:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021

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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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oSIST prEN ISO 14644-4:2021
ISO/DIS 14644-4:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 General . 2
3.2 Installation . 5
4 Abbreviations. 6
5 General . 6
6 Requirements . 9
6.1 Cleanroom requirements . 9
6.2 Other requirements .10
6.3 Documentation .10
7 Design .10
7.1 General .10
7.2 Conceptual Design.11
7.3 Basic Design .11
7.4 Detailed Design .12
7.5 Change management .12
8 Construction .13
8.1 General .13
8.2 Construction plan .13
8.2.1 General.13
8.2.2 Schedule .13
8.2.3 Quality Plan .13
8.2.4 Clean Build Protocol .13
8.3 Construction verification .14
8.4 Documentation .14
9 Start-up .14
9.1 General .14
9.2 Commissioning .15
9.2.1 General.15
9.2.2 Setting to Work .15
9.2.3 Operational and performance verifications .15
9.3 Training .15
9.4 Handover .15
9.5 Documentation .15
9.5.1 Commissioning documentation .15
9.5.2 Performance monitoring instructions.15
9.5.3 Maintenance instructions .16
9.5.4 Maintenance record .16
9.5.5 Record of training .16
Annex A (informative) Guidance on requirements .17
Annex B (informative) Guidance on design .26
Annex C (informative) Guidance on construction .47
Annex D (informative) Guidance on start-up .54
Bibliography .59
© ISO 2021 – All rights reserved iii

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Foreword
ISO (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
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 Electrotechnical 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 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 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 given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
This second edition cancels and replaces the first edition (ISO 14644-4:2001), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— Normative part is extended
— The process of gathering and defining requirements is included
— Scope is extended from classified cleanrooms to additional cleanliness attributes
— The text of the whole document has been revised or clarified to aid in application
A list of all parts in the ISO 14644 series and the ISO 14698 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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Introduction
Cleanrooms and associated controlled environments provide for the control of airborne particulate
contamination and, if relevant, other forms of contamination, to levels appropriate for accomplishing
contamination-sensitive activities. Products and processes that benefit from the control of airborne
contamination include those in such industries as aerospace, microelectronics, pharmaceuticals,
medical devices, food and research and development laboratories and some applications in healthcare.
Cleanrooms and associated controlled environments are classified for air cleanliness by particle
concentration (ISO 14644-1). Cleanliness attributes relating to chemicals, nano-scale particles and
viable particles (microorganisms) as well as cleanliness of surfaces can also be considered.
This part of ISO 14644 is one of the series of International Standards concerned with cleanrooms and
associated controlled environments prepared by ISO/TC 209.
This part, Part 4, provides guidance for the design, construction and start-up of cleanrooms, both
new and those undergoing modification or refurbishment. In this edition of Part 4, a more structured
approach is provided with separate normative sections on requirements, design, construction and
start-up, supported by four corresponding informative annexes.
For this edition, key recommendations and considerations include:
a) A structured approach with a logical sequential flow through the design, construction and start
up stages. There will normally be reviews and iterations of the requirements, contamination
control concepts, layouts and other considerations. The final design should be reviewed against the
requirements before construction commences and when construction is complete. The operation
and performance is verified against the requirements during start-up.
b) Inclusion of other cleanliness attributes. The ISO 14644 series has parts that deal with other
cleanliness attributes, namely chemicals, nano-scale particles, macro-particles and, in ISO 14698,
viable particles (microorganisms) as well as cleanliness of surfaces. These other attributes should
be considered if relevant, bearing in mind that the primary requirement for a cleanroom or clean
zone is that it meets a classification by airborne particle concentration according to ISO 14644-1.
c) Importance of a contamination risk assessment. Assessments should be carried out to better
understand the contamination risk and its impact on the process and product and to identify the
critical control points in the cleanroom or clean zone
d) A clear statement of requirements in terms of what users want to do and achieve along with
acceptance criteria for performance parameters. This is critical and should be captured prior to the
start of the design process.
e) Ventilation effectiveness. This revision focusses on the importance of ventilation effectiveness
through control of air flow patterns and clean up recovery rates. Two measures are identified: air
change effectiveness and contaminant removal effectiveness.
f) Using air supply rate for calculations of contaminant removal. This will make it possible to achieve
energy-efficient cleanrooms whilst achieving the required level of contamination.
g) Energy efficiency and lifecycle considerations. Energy efficiency in cleanrooms is very important
and is covered by ISO 14644 part 16.
h) A clean build protocol. This is included to minimise contamination during construction of the
cleanroom.
An ISO standard is not a textbook. Therefore only directly relevant information to “Cleanrooms and
associated controlled environments” is included in the informative annexes. Supporting information is
given in the Bibliography.
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oSIST prEN ISO 14644-4:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 14644-4:2021(E)
Cleanrooms and associated controlled environments —
Part 4:
Design, construction and start-up
1 Scope
This part of ISO 14644 specifies the process for creating a cleanroom from requirements through
to its design, construction and start-up. It applies to new and refurbished or 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 various stages including 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 standard is consideration of aspects including maintenance that will ensure continued
satisfactory operation for the entire lifecycle of the cleanroom.
NOTE Further guidance in respect of the above requirements is given in annexes A to D. Normative
parts 1, 2, 8, 9, 10, 12 and 17 of ISO 14644 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 standard:
— Specific operational activities, processes to be accommodated and process equipment in the
cleanroom installation
— Fire and safety regulations. The appropriate national and local regulations shall be respected and
addressed during the design as appropriate.
— On-going operation, cleaning and maintenance activities, which are covered by ISO14644-5
2 Normative 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 amendments 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 the normative document
referred to applies. Members of ISO and IEC maintain registers of currently valid International
Standards.
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
ISO 14644-2, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence
of cleanroom performance related to air cleanliness by particle concentration
ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Test methods
ISO 14644-16, Cleanrooms and associated controlled environments — Part 16: Energy efficiency in
cleanrooms and separative devices
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In case where there are air cleanliness requirements with respect to chemicals, nano scale particles
or viable particles (microorganisms), or where there are particle deposition rate requirements, the
associated document should be used as a normative reference:
ISO 14644-8, Cleanrooms and associated controlled environments — Part 8: Classification of air cleanliness
by chemical concentration (ACC)
ISO 14644-12, Cleanrooms and associated controlled environments — Part 12: Specifications for
monitoring air cleanliness by nanoscale particle concentration
ISO 14698-1, Cleanrooms and associated controlled environments — Biocontamination control — Part 1:
General principles and methods
ISO 14698-2, Cleanrooms and associated controlled environments — Biocontamination control — Part 2:
Evaluation and interpretation of biocontamination data
In cases where there are surface cleanliness requirements with respect to particles or chemicals the
following additional standards should be used as a normative reference:
ISO 14644-9, Cleanrooms and associated controlled environments — Part 9: Classification of surface
cleanliness by particle concentration
ISO 14644-10, Cleanrooms and associated controlled environments — Part 10: Classification of surface
cleanliness by chemical concentration
ISO 14644-17, Cleanrooms and associated controlled environments — Part 17: Particle deposition rate
applications
3 Terms and definitions
For the purposes of this part of ISO 14644 the following terms and definitions apply:
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General
3.1.1
Air change effectiveness
ACE
ratio between the recovery rate at a location or locations in a cleanroom (3.1.4) and the overall recovery
rate of the cleanroom after a contamination event
[1]
Note 1 to entry: The recovery rate is defined and measured in accordance with ISO 14644-3 .
[SOURCE: ISO 14644-16:2019. 3.2.7]
3.1.2
classification
method of assessing level of cleanliness against a specification for a cleanroom or clean zone
Note 1 to entry: Levels should be expressed in terms of an ISO Class, which represents maximum allowable
concentrations of particles in a unit volume of air.
[SOURCE: ISO 14644-1:2015, 3.1.4]
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3.1.3
cleanliness
condition not exceeding a specified level of contamination
[SOURCE: 14644-15:2017, 3.5]
3.1.4
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.1.5
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.1.6
commissioning
planned and documented series of inspections, adjustments, measurements, tests and verifications
carried out systematically to set the installation into correct technical operation as specified
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of testing
other forms of determination such as performing alternative calculations or reviewing documents
3.1.7
contaminant
any particle, chemical or microorganism that adversely affects the product or process
3.1.8
contaminant removal effectiveness
CRE
ratio of particle concentration in the air leaving the cleanroom to the average of particle concentration
in the working plane of the cleanroom, when particles entering from filtered supply air are ignored
Note 1 to entry: If the air leaves the cleanroom at more than one point then the weighted average of the particle
concentrations based on the relative flowrates can be used
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Note 2 to entry: The number and positioning of the sampling locations for determining the average particle
concentration in the working plane of the cleanroom can be based on the method given in 14644-1:2015
Note 3 to entry: The local particle concentration is dependent on the airflow pattern in the cleanroom and may
vary significantly in the cleanroom. CRE in a sub-area of interest in the cleanroom may be calculated by selecting
a single sampling location considered to be representative of the characteristics of the sub-area of interest
Note 4 to entry: Particles may be replaced by another airborne contaminant
[SOURCE: ISO 14644-16:2019, 3.2.5, modified — definition revised and Notes 1 to 3 to entry added].
3.1.9
customer
person or organisation that could or does receive a product or a service that is intended for or required
by this person or organisation
EXAMPLE Consumer, client, end-user, retailer, receiver of product or service from an internal process
beneficiary and purchaser.
Note 1 to entry: A customer can be internal or external to the organisation.
[SOURCE: ISO 9001-2015, 3.2.4]
3.1.10
non-unidirectional airflow
air distribution where the supply air entering the cleanroom or clean zone mixes with the internal air
by means of induction
[SOURCE: ISO 14644-1:2015, 3.2.8]
3.1.11
particle
minute piece of matter with defined physical boundaries
[SOURCE: ISO 14644-1:2015, 3.2.1]
3.1.12
setting to work
activities to bring a system from a static state into correct operation
3.1.13
source strength
number of airborne particles or other airborne contaminants considered
...