SIST EN ISO 14644-5:2025

Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)

This document specifies requirements for the establishment of an operations control programme (OCP) to ensure efficient cleanroom operation within specified cleanliness levels. The OCP includes management of personnel, entry and exit of personnel and materials, cleaning, maintenance and monitoring.
This document specifies operational requirements that relate to:
—     providing a system that specifies policies and operational procedures for maintaining cleanliness levels;
—     training of personnel;
—     transferring, installing and maintaining stationary equipment;
—     transferring material and portable equipment into and out of the cleanroom;
—     maintaining a personnel management programme that includes a gowning programme;
—     maintaining a cleaning programme that addresses special cleaning;
—     maintaining a cleanroom maintenance programme;
—     establishing an appropriate monitoring programme.
This document gives additional information in annexes for:
—     personnel management;
—     gowning;
—     training;
—     cleaning.
This document does not specifically address biocontamination control. For details on this topic, see ISO 14698-1 and ISO 14698-2.
This document does not apply to the following topics:
—     aspects of health and safety management that have no direct bearing on contamination control;
—     specific requirements for individual industries;
—     specific requirements for equipment and materials used or associated with processes and products;
—     design details of equipment;
—     cleaning agent compatibility with cleanroom materials.

Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2025)

Dieses Dokument legt Anforderungen an die Entwicklung eines Betriebssteuerungsprogramms (OCP) zur Sicherstellung des effizienten Reinraumbetriebs innerhalb der festgelegten Reinheitsgrade fest. Das OCP beinhaltet das Management von Personal, Betreten und Verlassen von Personal und Materialien, sowie Reinigung, Instandhaltung und Überwachung.
Dieses Dokument legt die betrieblichen Anforderungen bzgl. Folgenden fest:
   Bereitstellung eines Systems, das Methoden und Betriebsverfahrensanweisungen für die Aufrechterhaltung von Reinheitsgraden festlegt;
   Schulung von Personal;
   Übergabe, Installation und Instandhaltung ortsfester Ausrüstung;
   Übergabe von Material und tragbarer Ausrüstung in den und aus dem Reinraum;
   Aufrechterhaltung eines Personalmanagement-Programms, das ein Umkleideprogramm beinhaltet;
   Aufrechterhaltung eines Reinigungsprogramms, das Spezialreinigungen beinhaltet;
   Aufrechterhaltung eines Instandhaltungsprogramms für Reinräume;
   Erstellung eines geeigneten Überwachungsprogramms.
Dieses Dokument enthält in den Anhängen zusätzliche Informationen zu:
   Personalmanagement;
   Umkleiden;
   Schulung;
   Reinigung.
Die Biokontaminationskontrolle wird in diesem Dokument nicht spezifisch behandelt. Nähere Angaben zu diesem Thema sind in ISO 14698 1 und ISO 14698 2 zu finden.
Die folgenden Themen sind nicht Gegenstand dieses Dokuments:
   Aspekte des Gesundheits- und Sicherheitsmanagements, die keine direkte Bedeutung für die Kontaminationskontrolle haben;
   spezifische Anforderungen an einzelne Industrien;
   spezifische Anforderungen an Ausrüstung und Materialien, die für Prozesse und Produkte verwendet werden oder damit verbunden sind;
   Gestaltungsdetails der Ausrüstung;
   Kompatibilität von Reinigungsmitteln mit Reinraum-Materialien.

Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO 14644-5:2025)

Le présent document spécifie les exigences relatives à la mise en place d’un programme de maîtrise de l’exploitation (OCP, Operations Control Programme) afin de garantir une exploitation efficace des salles propres qui respecte les niveaux de propreté définis. L’OCP comprend la gestion du personnel, l’entrée et la sortie du personnel et des matières, le nettoyage, la maintenance et la surveillance.
Le présent document spécifie les exigences opérationnelles concernant:
—     la mise à disposition d’un système spécifiant des stratégies et des procédures opérationnelles permettant de maintenir les niveaux de propreté;
—     la formation du personnel;
—     le transfert, l’installation et la maintenance du matériel fixe;
—     le transfert des matières et du matériel mobile à l’intérieur et à l’extérieur de la salle propre;
—     la tenue à jour d’un programme de gestion du personnel comportant un programme d’habillage;
—     la tenue à jour d’un programme de nettoyage prévoyant un nettoyage spécial;
—     la tenue à jour d’un programme de maintenance de la salle propre;
—     la mise en place d’un programme de surveillance approprié.
Le présent document donne des informations supplémentaires en annexes pour:
—     la gestion du personnel;
—     l’habillage;
—     la formation;
—     le nettoyage.
Le présent document ne traite pas spécifiquement de la maîtrise de la biocontamination. Pour des détails à ce propos, voir l’ISO 14698-1 et l’ISO 14698-2.
Le présent document ne s’applique pas aux sujets suivants:
—     les aspects de gestion de la santé et de la sécurité qui ne concernent pas directement la maîtrise de la contamination;
—     les exigences propres à certaines industries;
—     les exigences spécifiques relatives au matériel et aux matières utilisés ou associés aux procédés et aux produits;
—     les détails de conception des équipements;
—     la compatibilité des produits de nettoyage avec les matériaux de la salle propre.

Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2025)

General Information

• Status: Published
• Public Enquiry End Date: 08-Sep-2024
• Publication Date: 22-Jul-2025
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 16-Jun-2025
• Due Date: 21-Aug-2025
• Completion Date: 23-Jul-2025
• Ref Project: EN ISO 14644-5:2025 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2025)

Relations

• Revises: SIST EN ISO 14644-5:2005 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
• Effective Date: 13-Dec-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2025
Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO 14644-5:2025)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-
5:2025)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO 14644-5:2025)
Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO
14644-5:2025)
Ta slovenski standard je istoveten z: EN ISO 14644-5:2025
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 14644-5
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-5:2004
English Version
Cleanrooms and associated controlled environments - Part
5: Operations (ISO 14644-5:2025)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 5:
- Partie 5: Exploitation (ISO 14644-5:2025) Betrieb (ISO 14644-5:2025)
This European Standard was approved by CEN on 25 May 2025.

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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-5:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-5:2025) 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 December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
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 14644-5:2004.
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 14644-5:2025 has been approved by CEN as EN ISO 14644-5:2025 without any
modification.
International
Standard
ISO 14644-5
Second edition
Cleanrooms and associated
2025-05
controlled environments —
Part 5:
Operations
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
Reference number
ISO 14644-5:2025(en) © ISO 2025

ISO 14644-5:2025(en)
© ISO 2025
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 14644-5:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviations . 4
5 General . 4
6 Impact assessment . 5
7 Operations Control . 6
7.1 General .6
7.2 Operations control programme .6
7.2.1 General .6
7.2.2 Elements of the OCP.7
7.2.3 Additional considerations for the operations control programme .7
7.3 Materials Flow .7
7.3.1 General .7
7.3.2 Incoming materials and components .8
7.3.3 Finished goods.8
7.3.4 Waste removal .8
7.3.5 Transfer of maintenance tools and test equipment .8
7.3.6 Transfer and installation of large or stationary equipment .8
7.4 Personnel management programme . .8
7.4.1 Requirements and restrictions .8
7.4.2 Gowning programme .9
7.4.3 Training .10
7.5 Cleaning programme .11
7.5.1 General .11
7.5.2 Requirements for the cleaning programme .11
7.5.3 Special cleaning . 12
7.6 Maintenance programme . 12
8 Monitoring programme .13
Annex A (informative) Personnel management . 14
Annex B (informative) Gowning . 16
Annex C (informative) Training .18
Annex D (informative) Cleaning .20
Bibliography .24

iii
ISO 14644-5:2025(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of t
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