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 zur Sicherstellung des effizienten Reinraumbetriebs innerhalb der festgelegten Reinheitsgrade fest. Das Betriebssteuerungsprogramm beinhaltet das Management des Zutritts und Verlassens von Personal, und Materialien sowie der Reinigung, Instandhaltung und Überwachung.
Dieses Dokument legt die betrieblichen Anforderungen bzgl. Folgenden fest:
   Die 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.
In diesem Dokument sind zu folgenden Themen zusätzliche Informationen zu finden:
   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: Not Published
• Public Enquiry End Date: 08-Sep-2024
• 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
• 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
oSIST prEN ISO 14644-5:2024
01-september-2024
Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO/DIS 14644-
5:2024)
Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS
14644-5:2024)
Reinräume und zugehörige Reinraumbereiche - Teil 5: Betrieb (ISO/DIS 14644-5:2024)
Salles propres et environnements maîtrisés apparentés - Partie 5: Exploitation (ISO/DIS
14644-5:2024)
Ta slovenski standard je istoveten z: prEN ISO 14644-5
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-5:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 14644-5:2024
oSIST prEN ISO 14644-5:2024
DRAFT
International
Standard
ISO/DIS 14644-5
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 5: 2024-06-17
Operations
Voting terminates on:
2024-09-09
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 14644-5:2024(en)
oSIST prEN ISO 14644-5:2024
DRAFT
ISO/DIS 14644-5:2024(en)
International
Standard
ISO/DIS 14644-5
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 5:
Operations
Voting terminates on:
Salles propres et environnements maîtrisés apparentés —
Partie 5: Exploitation
ICS: ISO ics
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 14644-5:2024(en)
ii
oSIST prEN ISO 14644-5:2024
ISO/DIS 14644-5:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Abbreviations . 4
5 General . 5
6 Impact assessment . 6
7 Operations Control . 7
7.1 Introduction .7
7.2 Operations control programme .7
7.2.1 General .7
7.2.2 Elements of the OCP.7
7.2.3 Additional considerations for the operations control programme .7
7.3 Materials Flow .8
7.3.1 General .8
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 .9
7.4 Personnel management programme . .9
7.4.1 Requirements and restrictions .9
7.4.2 Gowning programme .10
7.4.3 Training .10
7.5 Cleaning programme .11
7.5.1 General .11
7.5.2 Requirements for the cleaning programme . 12
7.5.3 Special cleaning . 12
7.6 Maintenance programme . 13
8 Monitoring programme .13
Annex A (informative) Personnel Management .15
Annex B (informative) Gowning . 17
Annex C (informative) Training . 19
Annex D (informative) Cleaning .21
Bibliography .25

iii
oSIST prEN ISO 14644-5:2024
ISO/DIS 14644-5:2024(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 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 Standardisation (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 14644-5:2004), which has been technically
revised. New normative content includes development of an impact assessment, development of an
Operations Control Programme and the associated programmes that support cleanroom operation, and
improved information concerning the movement of goods and materials into and out of the cleanrooms.
Informative sections have been condensed so as not to duplicate information available in books and papers.
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
oSIST prEN ISO 14644-5:2024
ISO/DIS 14644-5:2024(en)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to air and
surface cleanliness levels appropriate for accomplishing contamination-sensitive activities.
Consistent quality depends, in part, on cleanliness. Defined cleanliness levels for all c
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