prEN ISO 14644-14

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
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.
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
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 applicable to the following items:
— 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/

ISO/FDIS 14644-14:2025(en)
3.1
cleanliness
condition not exceeding a specified level of contamination
3.2
cleanroom
room within which the number concentration of airborne particles is controlled and classified, and which
is designed, constructed and operated in a manner to control the introduction, generation and retention of
particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air,
and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified
and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity,
pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.3
cleanroom suitability
ability to maintain the critical control attributes or condition of any clean zone when used as intended
Note 1 to entry: For the purposes of this part of ISO 14644, the assessment is based on airborne particle concentration.
3.4
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention of
contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the air,
and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be specified
and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative device.
Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature, humidity,
pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]
3.5
decontamination
reduction of unwanted matter to a defined level
[SOURCE: ISO 14644-7:2004, 3.7]
3.6
equipment
system designed for specific function(s), integrating materials, components and/or controls
EXAMPLE Testing and manufacturing equipment and machinery, equipment for transport and handling, storage
units, tools, furniture, doors, ceilings, Information Technology (IT) hardware and handling robots.
3.7
test environment
space in which the test is carried out, described by a set of parameters

ISO/FDIS 14644-14:2025(en)
4 General outline of the assessment
Cleanroom suitability assessment has the following outline.
a) Before the assessment can be executed, the customer and supplier shall agree upon the particle size
range(s), with reference to air cleanliness by particle concentration, designated by ISO Class N as
given in ISO 14644-1 and item to be tested including the modes of operation(s). Each selected mode of
operation shall be assessed separately.
b) A short description regarding how the equipment will be used in routine operation (with operating
parameters) shall be given to promote setting the appropriate testing condition and parameters.
c) Visual inspection (see Clause 5).
d) The procedure described in Clause 6 shall be used in order to establish a link to the ISO 14644-1
classification system.
e) Execution of measurements (see 6.2).
f) The data gathered will be processed and the results linked to the ISO classification system (see 6.2.9
and 6.2.10).
g) The results obtained shall conclude the equipment’s cleanroom suitability; the statement shall follow
the defined designation (see Clause 8).
Additional optional tests (not linked to ISO class N), such as total emission of particles or operational life
cycle test, are described in Annex B.
The method described in B.4 may be used to determine the average total emission of equipment and provides
data that may be used to determine the particle load on a cleanroom.
5 Visual inspection
Visual inspection of the equipment shall be carried out before and after any measurement-based assessment.
The visual inspection shall ensure that all packaging has been removed and that the equipment is undamaged
and that it is correctly assembled and appropriately connected to its required utilities.
Visual surface cleanliness shall be qualitatively assessed such that any subsequent quantifiable tests shall
not be compromised. This part of the visual inspection can include assessment for particles, surface films or
inappropriately located lubricants.
The objectives of this inspection are the following:
— identify contamination, such as particles and films originated from manufacturing, packaging,
transportation or initial assembly;
— identify contamination that has withstood any prior decontamination process.
It is not intended that this inspection will provide a measurement of surface cleanliness.
Depending on the location of the contamination, the results from visual inspection shall be
— recorded and available for comparison with the post-test visual inspection of surface cleanliness, and
— used as basis to direct a repeat or improved decontamination process.
Detection efficiency of visible contamination on equipment will depend upon the following factors:
— the accessibility and orientation of the surface to be inspected;
— the materials used for equipment construction, their surface condition and treatment;

ISO/FDIS 14644-14:2025(en)
— the viewing parameters (e.g. illumination, field of view, vision magnification, viewing distance).
6 Assessment of suitability by airborne particle concentration measurements
6.1 General
The objective of Clause 6 is to describe a suitability methodology using measurement of airborne particle
emissions at critical locations. By including measurement locations at, or close to, the locations of high
particle concentration (HPC), the intended use of the application is reflected.
This assessment methodology enables a link to the classification system of ISO 14644-1, in one or more
particle size ranges to be established.
In order to assess the cleanroom suitability of equipment, it is intended that the location(s) with HPC emitted
by the equipment be identified and included in the final suitability measurement. Since the size distribution
of the emitted particles is not known in advance, it is required that more than one particle size range is
measured. Ideally, three widely spread particle size ranges should be selected.
Subsequently, the particle concentrations thus determined from equipment assessment are compared with
the air cleanliness by particle concentration limits for ISO Class N as specified in ISO 14644-1.
For the equipment to be tested, it shall be ensured that cleanroom compliant design principles have been
incorporated. These principles include, but are not limited to, the following:
— selection of appropriate materials and surface finishes;
— avoidance of static air zones;
— design principles for cleanability;
— considerations for maintenance.
This measurement methodology is not intended to determine overall emission rates for the equipment
under test.
6.2 Assessment procedure
6.2.1 Overview
The flowchart in Figure 1 gives an overview of the necessary assessment steps.

ISO/FDIS 14644-14:2025(en)
Figure 1 — Overview of the assessment procedure
6.2.2 Requirements and considerations
When defining the scope of the suitability assessment, aspects that could influence the assessment results
shall be considered, for example (but not limited to):
— variability between the same type of equipment;
— pre-conditioning of the equipment to be tested (accumulated operating hours);
— running-in of equipment.
The test environment shall be agreed upon before testing (see 6.2.4 and 6.2.5).

ISO/FDIS 14644-14:2025(en)
6.2.3 Representative mode of operation
A representative mode of operation of equipment shall be defined, which ensures that particle emission
sources are detected. The mode of operation shall reflect the intended use of the equipment. If the equipment
can be operated in different modes of operation (e.g. with or without product), it shall be decided which of
these different modes form part of the assessment. Equipment parameters of operation shall be defined and
agreed upon before testing.
If standardized procedures exist, these procedures shall be taken into consideration. For non-standardized
handling, the manner of handling chosen shall be documented, and reasons for this choice shall be given.
6.2.4 Considerations for the test environment
The objective of these tests is to characterize and select a test environment prior to installing the equipment
that is to undergo assessment for cleanroom suitability.
Consideration should be given to whether all or some pre-tests are conducted at more than one measuring
plane. An illustration of selected measurement plane(s) may be added.
Information on measurement test methods and equipment can be obtained from ISO 14644-1 and
ISO 14644-3. The following shall be considered.
— Airborne particle concentration measurement: The aim is to confirm that the test environment is at least
one ISO class N (as given in ISO 14644-1) cleaner than the cleanroom or clean zone within which the
equipment is intended to be used.
— Airflow velocity measurement: Guidance range for vertical velocity should be in the range of 0,3 m/s to
0,5 m/s.
— Temperature: Guidance range should be 18 °C to 25 °C.
— Humidity: Guidance range should be 30 % RH to 70 % RH.
Additional informative pre-tests can include the following:
— airflow direction test and visualization;
— electrostatic and ion generator test;
— particle deposition test.
The results of the considerations shall be used for the determination of the test environment (see 6.2.5).
6.2.5 Determination of the test environment
The test environment shall provide a background level at least one ISO Class N (as given in ISO 14644-1)
cleaner than the cleanroom or clean zone in which the equipment is intended to be used.
NOTE Testing of equipment for ISO Class 1
...