ISO 14644-4:2022

Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up

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.

Salles propres et environnements maîtrisés apparentés — Partie 4: Conception, construction et mise en service

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.

General Information

• Status: Published
• Publication Date: 27-Nov-2022
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: ISO/TC 209 - Cleanrooms and associated controlled environments
• Drafting Committee: ISO/TC 209/WG 4 - Design and construction
• Current Stage: 6060 - International Standard published
• Start Date: 28-Nov-2022
• Due Date: 26-Oct-2022
• Completion Date: 28-Nov-2022

Relations

• Consolidates: ISO 14404-3:2017 - Calculation method of carbon dioxide emission intensity from iron and steel production — Part 3: Steel plant with electric arc furnace (EAF) and coal-based or gas-based direct reduction iron (DRI) facility
• Effective Date: 06-Jun-2022
• Revises: ISO 14644-4:2001 - Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
• Effective Date: 10-Dec-2016

Standards Content (Sample)

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 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
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ISO copyright office
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Published in Switzerland
ii
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
iii
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.
iv
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 pro
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