prEN ISO 14644-14
(Main)Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO/FDIS 14644-14:2025)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO/FDIS 14644-14:2025)
ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
- assessment of suitability with respect to biocontamination;
- testing for suitability of decontamination agents and techniques;
- cleanability of equipment and materials;
- requirements on design of equipment and selection of materials;
- physical properties of materials (e.g. electrostatic, thermal properties);
- optimizing performance of equipment for specific process applications;
- selection and use of statistical methods for testing;
- protocols and requirements for local safety regulations.
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO/FDIS 14644-14:2025)
Dieses Dokument legt eine Methodik zur Bewertung der Reinraumtauglichkeit von Geräten (z. B. Maschinen, Messgeräte, Prozessausrüstung, Komponenten und Werkzeuge) für die Anwendung in Reinräumen und zugehörigen kontrollierten Bereichen in Bezug auf die luftgetragene Partikelreinheit nach den Festlegungen in ISO 14644 1 fest. Der Partikelgrößenbereich reicht von 0,1 µm bis gleich oder größer als 5 µm (in ISO 14644 1 angegeben).
ANMERKUNG Sofern die zuständigen Behörden ergänzende Richtlinien oder Einschränkungen vorgeben, können geeignete Anpassungen der Methodik zur Bewertung erforderlich sein.
Dieses Dokument ist nicht für Folgendes anwendbar:
Bewertung der Tauglichkeit in Bezug auf die Biokontamination;
Prüfung zur Tauglichkeit von Dekontaminationsmitteln und -techniken;
Reinigungsfähigkeit der Geräte und Materialien;
Anforderungen an die konstruktive Auslegung von Geräten und die Auswahl von Materialien;
physikalische Materialeigenschaften (z. B. elektrostatische, thermische Eigenschaften);
Optimierung der Geräteleistung für spezifische Prozessanwendungen;
Auswahl und Anwendung statistischer Verfahren für die Prüfung;
Protokolle und Anforderungen hinsichtlich regionaler Sicherheitsvorschriften.
Salles propres et environnements maîtrisés apparentés - Partie 14: Évaluation de l'aptitude à l'emploi des équipements par la détermination de la concentration de particules en suspension dans l'air (ISO/FDIS 14644-14:2025)
ISO 14644-14:2016 définit une méthodologie pour évaluer l'aptitude de l'équipement (par exemple, machines, équipements de mesure, équipements de procédé, composants, outils) à être employé dans les salles propres et les environnements maîtrisés apparentés, pour ce qui concerne la propreté particulaire de l'air telle que spécifiée dans l'ISO 14644‑1. La taille des particules varie de 0,1 µm à 5 µm ou plus (indiquée dans l'ISO 14644‑1).
NOTE Lorsque les instances réglementaires imposent des lignes directrices ou des restrictions supplémentaires, il peut s'avérer nécessaire d'adapter la méthodologie d'évaluation en conséquence.
Les éléments suivants ne sont pas traités dans l'ISO 14644-14:2016:
- l'évaluation de l'aptitude à l'emploi par rapport à la biocontamination;
- les essais d'aptitude à l'emploi des agents et des techniques de décontamination;
- la nettoyabilité des équipements et matériaux;
- les exigences relatives à la conception de l'équipement et à la sélection des matériaux;
- les propriétés physiques des matériaux (par exemple, propriétés électrostatiques, thermiques);
- l'optimisation des performances de l'équipement pour des applications de procédé particulières;
- la sélection et l'utilisation de méthodes statistiques pour les essais;
- les protocoles et exigences relatifs à la réglementation locale sur la sécurité.
Čiste sobe in podobna nadzorovana okolja - 14. del: Ocena ustreznosti uporabe opreme na podlagi koncentracije lebdečih delcev (ISO/FDIS 14644-14:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2025
Čiste sobe in podobna nadzorovana okolja - 14. del: Ocena ustreznosti uporabe
opreme na podlagi koncentracije lebdečih delcev (ISO/FDIS 14644-14:2025)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO/FDIS 14644-14:2025)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO/FDIS
14644-14:2025)
Salles propres et environnements maîtrisés apparentés - Partie 14: Évaluation de
l'aptitude à l'emploi des équipements par la détermination de la concentration de
particules en suspension dans l'air (ISO/FDIS 14644-14:2025)
Ta slovenski standard je istoveten z: prEN ISO 14644-14
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.
FINAL DRAFT
International
Standard
ISO/FDIS 14644-14
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 14:
Assessment of suitability for use
Voting terminates on:
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l'aptitude à l'emploi des équipements
par la détermination de la concentration de particules en
suspension dans l'air
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WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 14644-14:2025(en) © ISO 2025
FINAL DRAFT
ISO/FDIS 14644-14:2025(en)
International
Standard
ISO/FDIS 14644-14
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 14:
Assessment of suitability for use
Voting terminates on:
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l'aptitude à l'emploi des équipements
par la détermination de la concentration de particules en
suspension dans l'air
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 SUPPOR TING DOCUMENTATION.
© ISO 2025
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO/FDIS 14644-14:2025(en) © ISO 2025
ii
ISO/FDIS 14644-14:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General outline of the assessment . 3
5 Visual inspection . 3
6 Assessment of suitability by airborne particle concentration measurements. 4
6.1 General .4
6.2 Assessment procedure .4
6.2.1 Overview .4
6.2.2 Requirements and considerations .5
6.2.3 Representative mode of operation .6
6.2.4 Considerations for the test environment .6
6.2.5 Determination of the test environment .6
6.2.6 Approximate identification of HPC location(s) .6
6.2.7 Precise determination of HPC location(s) .7
6.2.8 Suitability measurement(s) .7
6.2.9 Data processing .8
6.2.10 Reference to ISO 14644-1 classification system .9
7 Documentation . 10
7.1 General .10
7.2 Common documentation requirements .10
7.3 Documentation for visual inspection .10
7.4 Documentation for assessment of test environment .11
7.5 Documentation for classification measurement .11
8 Statement on cleanroom suitability .12
Annex A (informative) Example for data processing deriving from measurements .13
Annex B (informative) Additional optional tests . 17
Bibliography .20
iii
ISO/FDIS 14644-14:2025(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 this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 14644-14:2016), of which it constitutes a
minor revision. The changes are as follows:
— updated reference document;
— corrected title in Bibliography;
— removed references that are not mentioned in the text from the Bibliography.
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/FDIS 14644-14:2025(en)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from
the control of contamination include those in such industries as aerospace, microelectronics, optics, nuclear
and life sciences (pharmaceuticals, medical devices, food and healthcare).
This part of the ISO 14644 series links the cleanroom classification of air cleanliness by particle concentration
to the suitability of equipment for use in cleanrooms and associated controlled environments.
v
FINAL DRAFT International Standard ISO/FDIS 14644-14:2025(en)
Cleanrooms and associated controlled environments —
Part 14:
Assessment of suitability for use of equipment by airborne
particle concentration
1 Scope
This document specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring
equipment, process equipment, components and tools) for use in cleanrooms and associated controlled
environments, with respect to airborne particle cleanliness as specified in ISO 14644-1. Particle sizes range
from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644-1).
NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the
assessment methodology can be required.
This document is not applic
...
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