oSIST prEN ISO 14644-5:2024

Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS 14644-5:2024)

ISO 14644-5:2004 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on contamination control are not considered in this part of ISO 14644 and national and local safety regulations must be observed. This document considers all classes of cleanrooms used to produce all types of products. Therefore, it is broad in application and does not address specific requirements for individual industries. Methods and programmes for routine monitoring within cleanrooms are not covered in detail in this part of ISO 14644 but reference should be made to ISO 14644-2 and ISO 14644-3 for monitoring particles, and ISO 14698-1 and ISO 14698-2 for monitoring micro-organisms.

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)

L'ISO 14644-5:2004 spécifie les exigences de base pour l'exploitation des salles propres. Elle s'adresse aux personnes qui envisagent d'utiliser et d'exploiter une salle propre. Les aspects de sécurité qui ne concernent pas directement la maîtrise de la contamination ne sont pas pris en compte dans l'ISO 14644-5:2004. Les réglementations nationales ou locales en matière de sécurité doivent être respectées. Le présent document s'applique à toutes les classes de salles propres utilisées pour la production de tous les types de produits. Le présent document a donc un vaste domaine d'application et n'aborde pas les exigences particulières de telle ou telle industrie en particulier. Les méthodes et les programmes de surveillance régulière dans les salles propres ne sont pas abordés de manière détaillée dans l'ISO 14644-5:2004. Il convient cependant de se référer à l'ISO 14644-2 et à l'ISO 14644-3 pour la surveillance des particules, ainsi qu'à l'ISO 14698-1 et à l'ISO 14698-2 pour la surveillance des micro-organismes.

Čiste sobe in podobna nadzorovana okolja – 5. del: Delovanje (ISO/DIS 14644-5:2024)

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: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 01-Jul-2024
• Due Date: 18-Nov-2024
• Ref Project: prEN ISO 14644-5 - Cleanrooms and associated controlled environments - Part 5: Operations (ISO/DIS 14644-5:2024)

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-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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.
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BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
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ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
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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)
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
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
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
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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