SIST EN ISO 14644-15:2026

Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2026)

This document specifies requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments that are linked to the ISO standard for air cleanliness by chemical concentration (see ISO 14644-8).
This document does not apply to the following:
health and safety requirements;
compatibility with cleaning agents and techniques;
cleanability;
biocontamination;
specific requirements of equipment and materials for processes and products;
design details of equipment.

Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der Reinraumtauglichkeit von Ausrüstungsgegenständen und Materialien anhand der chemischen Luft- und Oberflächenkonzentration (ISO 14644-15:2026)

Dieses Dokument legt Anforderungen und Richtlinien zur Bewertung der chemischen luftgetragenen Reinheit von Ausrüstungsgegenständen und Materialien fest, die für den Gebrauch in Reinräumen und zugehörigen Reinraumbereichen vorgesehen sind, die mit der ISO-Norm für Luftreinheit anhand der chemischen Konzentration (siehe ISO 14644 8) zusammenhängen.
Die folgenden Bereiche werden von diesem Dokument nicht abgedeckt:
   Gesundheits- und Sicherheitsanforderungen;
   Kompatibilität mit Reinigungsmitteln und -techniken;
   Reinigungsfähigkeit;
   Biokontamination;
   bestimmte Anforderungen an Ausrüstungsgegenstände und Materialien für Prozesse und Produkte;
   Konstruktionsdetails der Ausrüstungsgegenstände.

Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de l'aptitude à l'emploi des équipements et des matériaux par la détermination de la concentration chimique aéroportée (ISO 14644-15:2026)

Le présent document spécifie des exigences et des lignes directrices relatives à l’évaluation de la propreté chimique de l’air d’équipements et de matériaux destinés à être utilisés dans des salles propres et des environnements maîtrisés apparentés. Ces exigences et lignes directrices sont liées à la norme ISO relative à la propreté chimique de l'air (voir l’ISO 14644-8).
Le présent document ne s’applique pas aux aspects suivants:
exigences de santé et de sécurité;
compatibilité avec les agents et les techniques de nettoyage;
nettoyabilité;
biocontamination;
exigences spécifiques applicables aux équipements et matériaux en ce qui concerne des procédés et des produits;
détails de la conception des équipements.

Čiste sobe in podobna nadzorovana okolja - 15. del: Ocena ustreznosti uporabe opreme in materialov na osnovi koncentracije onesnaževal v zraku (ISO 14644-15:2026)

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jan-2026
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 10-Jun-2026
• Due Date: 15-Aug-2026
• Ref Project: EN ISO 14644-15:2026 - Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2026)

Relations

• Revises: SIST EN ISO 14644-15:2018 - Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
• Effective Date: 17-Mar-2025

Overview

SIST EN ISO 14644-15:2026 defines requirements and guidelines for assessing the suitability of equipment and materials intended for use in cleanrooms and associated controlled environments, specifically regarding airborne chemical concentration. This standard, part of the ISO 14644 series, supports organizations in evaluating whether equipment and materials contribute to or help maintain required levels of airborne chemical cleanliness, as outlined in ISO 14644-8.

By focusing on chemical emissions, this international standard provides a structured approach for determining if products are appropriate for the sensitive environments found in industries such as pharmaceuticals, microelectronics, optics, and life sciences.

Key Topics

• Chemical Airborne Cleanliness Assessment: Outlines methods to determine if equipment or materials meet airborne chemical concentration requirements for cleanroom applications.
• Emission Measurement: Specifies approaches for measuring and calculating emissions, including both closed and open test setup designs to accommodate different object sizes and operational states.
• Representative Mode of Testing: Emphasizes the need for simulating actual conditions of use for both equipment and materials during assessment.
• Visual Inspection: Highlights qualitative inspection prior to and after quantitative testing, ensuring any contamination sources are accounted for and results are documented.
• Documentation Requirements: Provides guidance on common and test-specific documentation to support traceability and compliance.

Note: The standard does not cover health and safety requirements, compatibility with cleaning agents, cleanability, biocontamination, or process-specific requirements.

Applications

The practical application of ISO 14644-15 spans a range of contamination-sensitive industries:

• Pharmaceutical Manufacturing: Ensures equipment and materials do not release chemical contaminants that could compromise product integrity.
• Semiconductor and Microelectronics: Assists in controlling airborne molecular contamination (AMC) during highly sensitive fabrication processes.
• Healthcare and Medical Devices: Supports compliance with stringent cleanliness norms in environment-critical installations.
• Aerospace and Optics: Used in environments where even trace airborne chemical contaminants can impact performance or product quality.
• Food Technology and Packaging: Applies to environments requiring rigorous control of airborne chemical substances to maintain product safety.

By implementing this standard, organizations can:

• Evaluate new and existing equipment or materials for suitability in designated clean zones or cleanrooms
• Ensure continued compliance with regulated chemical air cleanliness levels
• Generate thorough documentation and evidence for customers, regulatory bodies, and internal quality assurance

Related Standards

Understanding SIST EN ISO 14644-15:2026 is enhanced by reference to related standards in the ISO 14644 family:

• ISO 14644-1: Classification of air cleanliness by particle concentration
• ISO 14644-8: Assessment of air cleanliness by chemical concentration - provides the foundational levels and measurement strategies referenced in Part 15
• ISO 14644-14: Assessment of suitability for use of equipment and materials with respect to particle cleanliness
• ISO 16000-6 and ISO 16017-1: Techniques for VOC sampling and analysis, referenced for understanding methods in chemical emission measurement

Summary

SIST EN ISO 14644-15:2026 delivers a comprehensive framework for assessing the chemical cleanliness of equipment and materials, contributing to the maintenance of cleanroom environments. By following its methodologies for emission measurement, representative testing, and documentation, organizations can ensure compliance, reduce contamination risk, and maintain the integrity of sensitive processes and products.

Relevant keywords: cleanrooms, airborne chemical concentration, emission measurement, equipment suitability, material assessment, ISO 14644 series, controlled environments, chemical cleanliness, contamination control, documentation, pharmaceutical manufacturing, microelectronics.

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 14644-15:2026
01-januar-2026
Čiste sobe in podobna nadzorovana okolja - 15. del: Ocena ustreznosti uporabe
opreme in materialov na osnovi koncentracije onesnaževal v zraku (ISO/FDIS
14644-15:2025)
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability
for use of equipment and materials by airborne chemical concentration (ISO/FDIS 14644
-15:2025)
Reinräume und zugehörige Reinraumbereiche - Teil 15: Bewertung der
Reinraumtauglichkeit von Ausrüstungsgegenständen und Materialien anhand der
chemischen Luft- und Oberflächenkonzentration (ISO/FDIS 14644-15:2025)
Salles propres et environnements maîtrisés apparentés - Partie 15: Évaluation de
l'aptitude à l'emploi des équipements et des matériaux par la détermination de la
concentration chimique aéroportée (ISO/FDIS 14644-15:2025)
Ta slovenski standard je istoveten z: prEN ISO 14644-15
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-15:2026 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 14644-15:2026
oSIST prEN ISO 14644-15:2026
FINAL DRAFT
International
Standard
ISO/FDIS 14644-15
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 15:
2025-11-14
Assessment of suitability for use
Voting terminates on:
of equipment and materials by
2026-02-06
airborne chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de l'aptitude à l'emploi des équipements et
des matériaux par la détermination de la concentration chimique
aéroportée
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 14644-15:2025(en) © ISO 2025

oSIST prEN ISO 14644-15:2026
FINAL DRAFT
ISO/FDIS 14644-15:2025(en)
International
Standard
ISO/FDIS 14644-15
ISO/TC 209
Cleanrooms and associated
Secretariat: ANSI
controlled environments —
Voting begins on:
Part 15:
Assessment of suitability for use
Voting terminates on:
of equipment and materials by
airborne chemical concentration
Salles propres et environnements maîtrisés apparentés —
Partie 15: Évaluation de l'aptitude à l'emploi des équipements et
des matériaux par la détermination de la concentration chimique
aéroportée
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 14644-15:2025(en) © ISO 2025

ii
oSIST prEN ISO 14644-15:2026
ISO/FDIS 14644-15:2025(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols . 4
5 Test setup . 4
5.1 General .4
5.2 Closed design .5
5.3 Closed design special application .6
5.4 Open design .7
6 Representative mode . 7
6.1 Equipment .7
6.2 Material .7
7 Visual inspection . 8
7.1 General .8
7.2 Equipment .8
7.3 Material .8
8 Test description . 9
9 Calculation of the measured concentrations . 9
10 Calculation of specific emission rate . 10
10.1 Calculation of specific emission rate — Closed design.10
10.2 Calculation of specific emission rate — Open design .10
11 Assessment . .11
11.1 General .11
11.2 Required input data .11
11.3 Calculation to determine the effect on a cleanroom or controlled zone . 12
11.4 Assessment of the suitability of material(s) or equipment for an existing cleanroom or
controlled zone . 12
12 Documentation .12
12.1 General . 12
12.2 Common documentation requirements . 13
12.3 Test documentation . . 13
12.4 Visual inspection . 13
12.4.1 Equipment . 13
12.4.2 Materials . 13
Annex A (informative) Example calculation for suitability assessment of one equipment
(existing installation) . 14
Annex B (informative) Example calculation for suitability assessment of wall material (existing
cleanroom/clean zone installation) .16
Annex C (informative) Suitability assessment of a combination of equipment and floor material
in a cleanroom to be designed . 17
Bibliography . 19

iii
oSIST prEN ISO 14644-15:2026
ISO/FDIS 14644-15:2025(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 14644-15:2017), of which it constitutes a
minor revision. The changes are as follows:
— term class (classification, classified) changed to level or assessment where appropriate and Introduction
reworded to accommodate the change;
— phrase “has to be” changed to “shall be”;
— updated ‘document titles’ and ‘Source’ dates where appropriate;
— removed references not mentioned in the text from the bibliography;
— minor editorial changes.
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 14644-15:2026
ISO/FDIS 14644-15:2025(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 industries such as aerospace, microelectronics, optics, nuclear,
and life sciences (pharmaceuticals, medical devices, food, healthcare).
The assessment of suitability of equipment for use in cleanrooms and associated controlled environments
is related to the assessment of air cleanliness for chemical contamination. Examples and suitability
assessments are given in Annexes A, B and C.

v
oSIST prEN ISO 14644-15:2026
oSIST prEN ISO 14644-15:2026
FINAL DRAFT International Standard ISO/FDIS 14644-15:2025(en)
Cleanrooms and associated controlled environments —
Part 15:
Assessment of suitability for use of equipment and materials
by airborne chemical concentration
1 Scope
This document specifies requirements and guidelines for assessing the chemical airborne cleanliness
of equipment and materials which are foreseen to be used in cleanrooms and associated controlled
environments that are linked to the ISO standard for air cleanliness by chemical concentration (see
ISO 14644-8).
This document does not apply to the following:
— health and safety requirements;
— compatibility with cleaning agents and techniques;
— cleanability;
— biocontamination;
— specific requirements of equipment and materials for processes and products;
— design details of equipment.
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 14644-8:2022, Cleanrooms and associated controlled environments — Part 8: Assessment of air cleanliness
by chemical concentration (ACC)
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/

oSIST prEN ISO 14644-15:2026
ISO/FDIS 14644-15:2025(en)
3.1
air cleanliness by chemical concentration
ACC
quantity of chemicals detected in the air, expressed in terms of an ISO-ACC level N, which represents the
maximum allowable concentration of a given chemical species or a group of chemical species, expressed in
grams per cubic metre
Note 1 to entry: This definition does not include macromolecules of biological origin, which are judged to be particles.
[SOURCE: ISO 14644-8:2022, 3.1.2]
3.2
breakthrough volume
maximum purge gas (3.12) volume that can be drawn through a trapping system without loss of analyte at a
specific temperature
3.3
chemical contamination
non-particulate substances that can have a deleterious effect on the product, process or equipment
[SOURCE: ISO 14644-8:2022, 3.1.1]
3.4
cleanliness
condition not exceeding a specified level of contamination
3.5
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 may also be specified
and controlled.
Note 3 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature, humidity,
pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.1]
3.6
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 may also be specified
and controlled.
Note 3 to entry: A clean zone(s) may be a defined space within a cleanroom or may be achieved by a separative device.
Such a device may be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters may also be controlled as required, e.g. temperature, humidity,
pressure, vibration and electrostatic.
[SOURCE: ISO 14644-1:2015, 3.1.2]

oSIST prEN ISO 14644-15:2026
ISO/FDIS 14644-15:2025(en)
3.7
controlled zone
designated space in which the concentration of at least one contamination category (particles, chemical,
biocontamination) in air and/or on surfaces is controlled and specified and which is constructed and used in
a manner to minimize the introduction and impact of contamination
Note 1 to entry: Levels of cleanliness attributes such as chemical and viable concentrations in the air or cleanliness in
terms of particle, chemical and viable concentrations on surfaces may be specified by class(es).
Note 2 to entry: Other relevant parameters may also be controlled as necessary, e.g. temperature, humidity and
pressure, vibration and electrostatic.
Note 3 to entry: A controlled zone can be a defined space within a cleanroom or may be achieved by a separative
device. Such a device may be located inside or outside a cleanroom.
3.8
emission
contaminants that are discharged into the environment
[SOURCE: ISO 2889:2023, 3.30]
Note 1 to entry: For the purposes of this document, only chemical emission is considered.
3.9
emission rate
rate describing the mass of one or more volatile chemical(s) emitted from the equipment or material per
time unit
3.10
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; IT hardware; handling robots.
[SOURCE: ISO 14644-14:2025, 3.6]
3.11
material
single substance or composite
Note 1 to entry: It might be necessary to provide material in a representative form to enable testing.
3.12
purge gas
gas or gas mixture to carry contaminant to a defined outlet
Note 1 to entry: In a controlled or clean zone (3.6) or a cleanroom (3.5), filtered air might be used as purge gas.
Note 2 to entry: A test environment (3.16) might be purged with air or other gases or gas mixtures to carry the
contaminant to a trapping system or measurement device.
3.13
representative form
material sample produced to represent the intrinsic physical and chemical properties of an object
3.14
representative mode
mode of operation that reflects the intended use of the equipment

oSIST prEN ISO 14644-15:2026
ISO/FDIS 14644-15:2025(en)
3.15
specific emission rate
normalized mass flow of chemical contaminants emitted from a test object
Note 1 to entry: Material-specific emission rate (3.9) is based on surface area.
Note 2 to entry: Equipment-specific emission rate is based on one single unit of equipment.
3.16
test environment
space in which the test is carried out, described by a set of parameters
[SOURCE: ISO 14644-14:2025, 3.7]
4 Symbols
Symbol Meaning Unit
p Background concentration in the test environment without the test g/m
b
object
p Concentration in the test environment with the test object g/m
o
p Chemical mass concentration in the cleanroom/controlled zone g/m
c
p Chemical mass concentration of the make up air g/m
m
F Sampling flow rate background measurement m /s
b
F Sampling flow rate object measurement m /s
o
m Total sampled mass emitted from the test environment with test g
o
object
m Total sampled mass emitted from the test environment without test g
b
object
t Sampling duration object measurement s
o
t Sampling duration background measurement s
b
x Specific metric related to the test object m for materials
“unit” for equipment
x Quantity related to the assessed object m for materials
“unit” for equipment
q Specific emission rate of the test object g/(m s) or g/(unit · s)
o
n Air change rate through the test environment 1/s
t
n Make up air change rate 1/s
m
n Recirculated air change rate 1/s
r
V Volume of air in the cleanroom/ controlled zone m
c
V Volume of the test environment m
t
α Specified efficiency of the chemical filtration system —
5 Test setup
5.1 General
The test setup shall be designed for collecting representative samples of contaminants within the test
environment in order to assess specific emission rates from equipment and/or materials. It can be designed
as closed (see Figure 1), closed special application (see Figure 2) or open (see Figure 3).
Closed design is used for low specific emission rates and is the preferred method. Lar
...