SIST EN ISO 14644-3:2020
(Main)Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)
This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational.
The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices.
NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
Reinräume und zugehörige Reinraumbereiche - Teil 3: Prüfverfahren (ISO 14644-3:2019, korrigierte Fassung 2020-06)
Dieses Dokument umfasst Prüfverfahren zur Unterstützung des Betriebs für Reinräume und reine Bereiche, im Hinblick auf die Erfüllung von Luftreinheitsklassifizierungen, weiteren Reinheitsattributen und zugehörigen geregelten Bedingungen.
Es werden Leistungsprüfungen für zwei Arten von Reinräumen und reinen Bereichen festgelegt, solche mit turbulenzarmer Verdrängungsströmung und solche mit turbulenter Mischströmung. Es werden drei Betriebszustände betrachtet: Bereitstellung, Leerlauf, Fertigung.
Die Prüfverfahren, empfohlene Prüfgeräte und Prüfverfahren zur Bestimmung von Kenngrößen für die Leistung werden angegeben. An Stellen, an denen das Prüfverfahren durch die Art des Reinraums oder reinen Bereichs beeinflusst wird, werden alternative Verfahren vorgeschlagen.
Für einige Prüfungen werden mehrere unterschiedliche Verfahren und Geräte empfohlen, so dass verschiedenen Nutzungsarten Rechnung getragen werden kann. Soweit zwischen Kunden und Lieferanten vereinbart, können alternative, nicht in diesem Dokument beschriebene Verfahren angewendet werden. Solche Verfahren liefern nicht zwingend gleichwertige Messungen.
Dieses Dokument ist nicht auf die Messung von Produkten oder Prozessen in Reinräumen, reinen Bereichen oder SD-Modulen anwendbar.
ANMERKUNG Dieses Dokument nimmt nicht in Anspruch, mit seiner Anwendung verbundene Sicherheitsaspekte zu behandeln (z. B. beim Einsatz gefährlicher Stoffe, Arbeitsgänge und Geräte). Es liegt in der Verantwortlichkeit des Anwenders dieses Dokuments, geeignete Verhaltensregeln für den Arbeits- und Gesundheitsschutz festzulegen und vor der Anwendung zu klären, ob einschränkende Vorschriften zu berücksichtigen sind.
Salles propres et environnements maîtrisés apparentés - Partie 3: Méthodes d'essai (ISO 14644-3:2019, Version corrigée 2020-06)
Le présent document fournit des méthodes d'essai relatives au fonctionnement des salles propres et zones propres dans le but de satisfaire à la classification de propreté de l'air, aux autres attributs de propreté et aux conditions maîtrisées associées.
Des essais de performance sont spécifiés pour deux types de salles propres et de zones propres: des essais mettant en œuvre un flux d'air soit unidirectionnel, soit non unidirectionnel et dans trois états possibles d'occupation: après construction, au repos et en activité.
Les méthodes d'essai, l'appareillage d'essai recommandé ainsi que les modes opératoires d'essai permettant de déterminer les paramètres de performance sont indiqués. Quand la méthode d'essai est susceptible de modification en fonction du type de salle propre ou de zone propre dont il est question, des modes opératoires alternatifs sont proposés.
Pour certains essais, plusieurs méthodes et appareils sont recommandés afin de tenir compte des considérations spécifiques de plusieurs applications. Des méthodes alternatives ne figurant pas dans le présent document peuvent être utilisées sous réserve d'un accord entre le client et le fournisseur. Des méthodes alternatives ne fournissent pas nécessairement des mesurages équivalents.
Le présent document ne s'applique pas au mesurage effectué sur des produits ou des procédés situés dans les salles propres, les zones propres ou les dispositifs séparatifs.
NOTE Le présent document ne prétend pas traiter les aspects de sécurité associés à son utilisation (par exemple, lors de la mise en œuvre de matériaux, d'opérations et d'équipements dangereux). Il relève de la responsabilité de l'utilisateur du présent document d'établir des pratiques appropriées en matière d'hygiène et de sécurité et de déterminer l'applicabilité des limitations réglementaires avant son utilisation.
Čiste sobe in podobna nadzorovana okolja - 3. del: Preskusne metode (ISO 14644-3:2019, popravljena verzija 2020-06)
Ta dokument določa preskusne metode v podporo postopkom v čistih sobah in čistih območjih za izpolnjevanje klasifikacije čistosti zraka, drugih atributov čistosti in povezanih nadzorovanih pogojev. Preskusi učinkovitosti so določeni za dve vrsti čistih sob in čistih območij: z enosmernim pretokom zraka in z večsmernim pretokom zraka ter v treh različnih stanjih: kot pri izvajanju, pri počitku in delovanju. Podane so preskusne metode, priporočene preskusne naprave in preskusni postopki za določanje parametrov učinkovitosti. Kadar na preskusno metodo vpliva vrsta čiste sobe ali čistega območja, so predlagani nadomestni postopki. Pri nekaterih preskusih je predlaganih več različnih metod in naprav za različne končne primere. Naročnik in dobavitelj se lahko dogovorita o uporabi nadomestnih metod, ki niso vključene v ta dokument. Ni nujno, da nadomestne metode zagotovijo enakovredne meritve. Ta dokument se ne uporablja za meritve izdelkov ali postopkov v čistih sobah, čistih območjih ali naprave za ločevanje.
General Information
Relations
Overview
SIST EN ISO 14644-3:2020 (ISO 14644-3:2019, corrected 2020-06) specifies standardized test methods for assessing the performance of cleanrooms and associated controlled environments (clean zones). It supports the operation and verification needed to meet air cleanliness classification, related cleanliness attributes and controlled environmental conditions. The standard covers performance testing for two airflow types - unidirectional and non‑unidirectional - in three occupancy states: as‑built, at‑rest and operational.
Key technical topics and requirements
- Performance test scope: Methods, recommended test apparatus and procedures for determining cleanroom performance parameters.
- Airflow types and occupancy states: Alternative procedures are provided where test methods depend on airflow pattern or occupancy (unidirectional vs non‑unidirectional; as‑built, at‑rest, operational).
- Test areas covered (selected topics from the standard):
- Air pressure difference, airflow rate and airflow direction/visualization
- Recovery testing (cleanroom recovery after contamination)
- Temperature and relative humidity measurements
- Installed filter system leakage and containment leak tests
- Electrostatic/ion generator evaluation and particle deposition tests
- Segregation and supporting tests to evaluate functionality
- Test apparatus options: Several recommended methods and instruments are included to suit different end‑use considerations; alternative methods may be used by agreement between customer and supplier (note: alternative methods may not be equivalent).
- Reporting: Requirements for test reports and checklists to document test methods and results.
- Limitations: The standard is not applicable to measurement of products or specific processes conducted within cleanrooms, and it does not address safety practices related to hazardous materials or operations.
Practical applications and who uses this standard
ISO 14644-3 is used by organizations that design, build, commission, validate and operate contamination‑sensitive environments, including:
- Cleanroom designers and HVAC engineers
- Validation, quality assurance and compliance teams in pharmaceuticals, medical devices, microelectronics, aerospace, food and healthcare industries
- Facility managers, test laboratories and third‑party auditors performing performance qualification and periodic retesting
Use cases include commissioning and acceptance testing, periodic performance verification, troubleshooting airflow/containment issues, and documenting compliance with air cleanliness classes.
Related standards
- ISO 14644-1 (air cleanliness classification by particle concentration)
- ISO 14644-4 (design, construction and start‑up)
- ISO 14644-7 (separative devices)
- ISO 14644-8 / -9 / -10 (other cleanliness attributes: chemical and surface metrics)
- ISO 14644-12 and ISO 14698 (nanoscale and viable particle considerations)
Keywords: ISO 14644-3, SIST EN ISO 14644-3:2020, cleanroom test methods, air cleanliness classification, unidirectional airflow, operational qualification, filter leakage testing, clean zones.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2020
Nadomešča:
SIST EN ISO 14644-3:2006
Čiste sobe in podobna nadzorovana okolja - 3. del: Preskusne metode (ISO 14644-
3:2019, popravljena verzija 2020-06)
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-
3:2019, Corrected version 2020-06)
Reinräume und zugehörige Reinraumbereiche - Teil 3: Prüfverfahren (ISO 14644-
3:2019, korrigierte Fassung 2020-06)
Salles propres et environnements maîtrisés apparentés - Partie 3: Méthodes d'essai
(ISO 14644-3:2019, Version corrigée 2020-06)
Ta slovenski standard je istoveten z: EN ISO 14644-3:2019
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.
EN ISO 14644-3
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-3:2005
English Version
Cleanrooms and associated controlled environments - Part
3: Test methods (ISO 14644-3:2019, Corrected version
2020-06)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 3:
- Partie 3: Méthodes d'essai (ISO 14644-3:2019, Prüfverfahren (ISO 14644-3:2019, korrigierte Fassung
Version corrigée 2020-06) 2020-06)
This European Standard was approved by CEN on 24 July 2019.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 17 June 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-3:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-3:2019) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14644-3:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14644-3:2019, Corrected version 2020-06 has been approved by CEN as EN ISO 14644-
3:2019 without any modification.
INTERNATIONAL ISO
STANDARD 14644-3
Second edition
2019-08
Corrected version
2020-06
Cleanrooms and associated controlled
environments —
Part 3:
Test methods
Salles propres et environnements maîtrisés apparentés —
Partie 3: Méthodes d'essai
Reference number
ISO 14644-3:2019(E)
©
ISO 2019
ISO 14644-3:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Terms related to airborne particles . 3
3.3 Terms related to air filters and systems . 3
3.4 Terms related to airflow and other physical states . 4
3.5 Terms related to electrostatic measurement . 5
3.6 Terms related to measuring apparatus and measuring conditions . 5
3.7 Terms related to occupancy states . 6
4 Test procedures . 6
4.1 Cleanroom tests . 6
4.1.1 General. 6
4.1.2 Supporting tests . 7
4.2 Principle . 7
4.2.1 Air pressure difference test . 7
4.2.2 Airflow test . 7
4.2.3 Airflow direction test and visualization . 8
4.2.4 Recovery test . 8
4.2.5 Temperature test . 8
4.2.6 Humidity test . 8
4.2.7 Installed filter system leakage tests . 8
4.2.8 Containment leak test . . 8
4.2.9 Electrostatic and ion generator tests . 8
4.2.10 Particle deposition test . . 8
4.2.11 Segregation test . 9
5 Test reports . 9
Annex A (informative) Choice of supporting tests and checklist .10
Annex B (informative) Supporting test methods .14
Annex C (informative) Test apparatus .43
Bibliography .51
ISO 14644-3:2019(E)
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 ISO/TC 209, Cleanrooms and associated controlled environments.
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.
This second edition of ISO 14644-3 cancels and replaces the first edition (ISO 14644-3:2005), which has
been technically revised. The main changes compared to the previous edition are as follows:
— Clause B.7 has been simplified and corrected to address concerns over its complexity and noted errors;
— guidance concerning classification of air cleanliness by airborne particle concentration has been
[1]
moved to 14644-1
— the text of the whole document has been revised or clarified to aid in application.
A list of all parts in the ISO 14644 series can be found on the ISO website.
This corrected version of ISO 14644-3:2019 incorporates the following corrections:
— cross-references have been corrected in Table A.1, B.4.4, C.1, C.4.2 and C.4.3;
— the wording has been changed in B.2.1 a), Table B.2;
— old Figure B.2 has been removed.
iv © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Introduction
Cleanrooms and associated controlled environments provide control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that
benefit from the control of airborne contamination include those in such industries as aerospace,
microelectronics, pharmaceuticals, medical devices, healthcare and food.
This document sets out appropriate test methods for measuring the performance of a cleanroom, a
clean zone or an associated controlled environment, including separative devices and controlled zones,
together with all associated structures, air treatment systems, services and utilities.
NOTE Not all cleanroom parameter test procedures are shown in this document. The procedure and
apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles
[1]
are provided in ISO 14644-1, and specifications for monitoring air cleanliness by nanoscale particle
[8]
concentrations are provided in ISO 14644-12. The procedures and apparatus to characterize other parameters,
of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere
in other documents prepared by ISO/TC 209 [for example, procedures for control and measurement of viable
[3]
materials (ISO 14698 series), testing cleanroom functionality (ISO 14644-4 ), and testing of separative devices
[4]
(ISO 14644-7 )]. In addition, other standards can be considered to be applicable. Other cleanliness attribute
[5] [6]
levels can be determined using ISO 14644-8 (levels of air cleanliness by chemicals), ISO 14644-9 (levels
[7]
of surface cleanliness by particle concentration) and ISO 14644-10 (levels of surface cleanliness by chemical
concentration).
INTERNATIONAL STANDARD ISO 14644-3:2019(E)
Cleanrooms and associated controlled environments —
Part 3:
Test methods
1 Scope
This document provides test methods in support of the operation for cleanrooms and clean zones to
meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional
airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest
and operational.
The test methods, recommended test apparatus and test procedures for determining performance
parameters are provided. Where the test method is affected by the type of cleanroom or clean zone,
alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate
different end-use considerations. Alternative methods not included in this document can be used by
agreement between customer and supplier. Alternative methods do not necessarily provide equivalent
measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean
zones or separative devices.
NOTE This document does not purport to address safety considerations associated with its use (for example,
when using hazardous materials, operations and equipment). It is the responsibility of the user of this document
to establish appropriate safety and health practices and to determine the applicability of regulatory limitations
prior to use.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1 General terms
3.1.1
cleanroom
room within which the number concentration of airborne particles (3.2.1) 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 (3.2.4) is specified.
ISO 14644-3:2019(E)
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]
3.1.2
clean zone
defined space within which the number concentration of airborne particles (3.2.1) 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 (3.2.4) 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 (3.1.1) 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]
3.1.3
installation
cleanroom (3.1.1) or one or more clean zones (3.1.2), together with all associated structures, air-
treatment systems, services and utilities
[SOURCE: ISO 14644-1:2015, 3.1.3]
3.1.4
separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between
the inside and outside of a defined volume
Note 1 to entry: Some industry-specific examples of separative devices are clean air hoods, containment
enclosures, glove boxes, isolators and mini-environments.
[SOURCE: ISO 14644-7:2004, 3.17]
3.1.5
resolution
smallest change in a quantity being measured that causes a perceptible change in the corresponding
indication
Note 1 to entry: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend
on the value of a quantity being measured.
[SOURCE: ISO 14644-1:2015, 3.4.1]
3.1.6
sensitivity
quotient of the change in an indication of a measuring system and the corresponding change in a value
of the quantity being measured
2 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
3.2 Terms related to airborne particles
3.2.1
airborne particle
solid or liquid object suspended in air, viable or non-viable, sized between 1 nm and 100 µm
Note 1 to entry: For classification purposes, refer to ISO 14644-1:2015, 3.2.1.
3.2.2
count median particle diameter
median particle diameter based on the number of particles
Note 1 to entry: For the count median, one half of the particle number is contributed by the particles with a size
smaller than the count median size, and one half by particles larger than the count median size.
3.2.3
mass median particle diameter
median particle diameter based on the particle mass
Note 1 to entry: For the mass median, one half of mass of all particles is contributed by particles with a size
smaller than the mass median size, and one half by particles larger than the mass median size.
3.2.4
particle concentration
number of individual particles per unit volume of air
[SOURCE: ISO 14644-1:2015, 3.2.3]
3.2.5
particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent
to the response produced by the particle being measured
Note 1 to entry: For light-scattering airborne-particle instruments, the equivalent optical diameter is used.
[SOURCE: ISO 14644-1:2015, 3.2.2]
3.2.6
particle size distribution
cumulative distribution of particle concentration (3.2.4) as a function of particle size (3.2.5)
[SOURCE: ISO 14644-1:2015, 3.2.4]
3.2.7
test aerosol
gaseous suspension of solid and/or liquid particles with known and controlled size distribution and
concentration
3.3 Terms related to air filters and systems
3.3.1
aerosol challenge
challenging of a filter or an installed filter system (3.3.6) by test aerosol (3.2.7)
3.3.2
designated leak
maximum allowable penetration, which is determined by agreement between customer and supplier,
through a leak (3.3.8), detectable during scanning (3.3.9) of a filter installation (3.1.3) with light-
scattering airborne-particle counters (LSAPC) or aerosol photometers (3.6.2)
ISO 14644-3:2019(E)
3.3.3
dilution system
system wherein aerosol is mixed with particle-free dilution air in a known volumetric ratio to reduce
concentration
3.3.4
filter system
assembly composed of filter, frame and other support mechanism or other housing
3.3.5
final filter
filter in a final position before the air enters the cleanroom (3.1.1) or clean zone (3.1.2)
3.3.6
installed filter system
filter system (3.3.4) mounted in the ceiling, wall, apparatus or duct
3.3.7
installed filter system leakage test
test performed to confirm that the filters are properly installed by verifying that there is absence of
bypass leakage of the filter installation (3.1.3), and that the filters and the grid system are free of defects
and leaks (3.3.8)
3.3.8
leak
penetration of contaminants that exceed an expected value of downstream
concentration through lack of integrity or defects
3.3.9
scanning
method for disclosing leaks (3.3.8) in filters and parts of units, whereby the probe inlet of an aerosol
photometer (3.6.2) or a light-scattering airborne-particle counter is moved in overlapping strokes
across the defined test area
3.4 Terms related to airflow and other physical states
3.4.1
air change rate
air exchange rate
rate expressing number of air changes per unit of time and calculated by dividing the volume of air
delivered in the unit of time by the volume of the cleanroom (3.1.1) or clean zone (3.1.2)
3.4.2
measuring plane
cross-sectional area for testing or measuring a performance parameter such as the airflow velocity
3.4.3
non-unidirectional airflow
air distribution where the supply air entering the cleanroom (3.1.1) or clean zone (3.1.2) mixes with the
internal air by means of induction
[SOURCE: ISO 14644-1:2015, 3.2.8]
3.4.4
supply air volume flow rate
air volume per unit of time supplied into a cleanroom (3.1.1) or clean zone (3.1.2) from final filters (3.3.5)
or air ducts
4 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
3.4.5
total air volume flow rate
air volume per unit of time that passes through a section of a cleanroom (3.1.1) or clean zone (3.1.2)
3.4.6
unidirectional airflow
controlled airflow through the entire cross-section of a cleanroom (3.1.1) or a clean zone (3.1.2) with a
steady velocity and airstreams that are considered to be parallel
[SOURCE: ISO 14644-1:2015, 3.2.7]
3.4.7
uniformity of velocity
unidirectional airflow (3.4.6) pattern in which the point-to-point readings of velocity (speed and
direction of airflow) are within a defined percentage of the average airflow velocity
3.5 Terms related to electrostatic measurement
3.5.1
discharge time
time required to reduce the voltage to the level, positive or negative, to which an isolated conductive
monitoring plate was originally charged
3.5.2
offset voltage
voltage that accumulates on an initially uncharged isolated conductive plate when that plate is exposed
to an ionized air environment
3.5.3
static-dissipative property
capability for reducing electrostatic charge on work or product surface, as a result of conduction or
other mechanism to a specific value or nominal zero charge level
3.5.4
surface voltage level
positive or negative voltage level of electrostatic charging on work or product surface, as indicated by
use of suitable apparatus
3.6 Terms related to measuring apparatus and measuring conditions
3.6.1
aerosol generator
apparatus capable of generating particulate matter having appropriate size range (e.g. 0,05 µm to
2 µm) at a constant concentration, which can be produced by thermal, hydraulic, pneumatic, acoustic or
electrostatic means
3.6.2
aerosol photometer
light-scattering airborne particle (3.2.1) mass concentration measuring apparatus, which uses a
forward-scattered-light optical chamber to make measurements
3.6.3
airflow capture hood with measuring device
device with apparatus to completely cover the filter or air diffuser, and collect the air to directly
measure the air volume flow rate
ISO 14644-3:2019(E)
3.6.4
LSAPC
light scattering airborne particle counter
apparatus capable of counting and sizing single airborne particles (3.2.1) and reporting size data in
terms of equivalent optical diameter
Note 1 to entry: The specifications for a particle counter are given in ISO 21501-4.
[SOURCE: ISO 14644-1:2015, 3.5.1, modified — The term "light scattering discrete airborne particle
counter" has been removed. Note 1 to entry has been reworded.]
3.6.5
witness plate
material of defined surface area used in lieu of direct evaluation of a specific surface that is either
inaccessible or too sensitive to be handled
3.7 Terms related to occupancy states
3.7.1
as-built
condition where the cleanroom (3.1.1) or clean zone (3.1.2) is complete with all services connected and
functioning but with no equipment, furniture, materials or personnel present
[SOURCE: ISO 14644-1:2015, 3.3.1]
3.7.2
at-rest
condition where the cleanroom (3.1.1) or clean zone (3.1.2) is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present
[SOURCE: ISO 14644-1:2015, 3.3.2]
3.7.3
operational
agreed condition where the cleanroom (3.1.1) or clean zone (3.1.2) is functioning in the specified
manner, with equipment operating and with the specified number of personnel present
[SOURCE: ISO 14644-1:2015, 3.3.3]
4 Test procedures
4.1 Cleanroom tests
4.1.1 General
[1]
ISO 14644-1 shall be carried out in order to classify a cleanroom or clean zone by airborne particle
concentration. Additional cleanliness attributes should be chosen if required (see Table 1).
NOTE Each standard contains specifications for test methods based on the characteristics of specific
attributes, guidance on evaluating the test data and specifications for test apparatus.
Table 1 — Cleanliness attribute tests for cleanrooms and clean zones
General description Referenced in
[6]
Levels of surface cleanliness by particle concentration ISO 14644-9
[5]
Levels of air cleanliness by chemical concentration ISO 14644-8
[7]
Levels of surface cleanliness by chemical concentration ISO 14644-10
[8]
Monitoring air cleanliness by nanoscale particle concentration ISO 14644-12
6 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
4.1.2 Supporting tests
Table 2 lists other appropriate tests that can be used for measuring the performance of a cleanroom or
clean zone installation. These tests may be applied in each of the three designated occupancy states;
refer to details in Annex B for suggested applications. These tests may not be all-inclusive. Also, they
may not all be required for any given project. Tests and test methods should be selected in a manner
agreed between the customer and supplier. Selected tests can also be repeated on a regular basis as
part of routine monitoring or periodic testing. Guidelines for the selection of tests and a checklist of
tests are given in Annex A. Test methods are outlined in Annex B.
NOTE The test methods described in Annex B are in outline form only. Specific methods can be developed to
meet the needs of the particular application.
Table 2 — Supporting tests
Reference in ISO 14644-3
Supporting tests
Principle Procedure Apparatus
Air pressure difference test 4.2.1 B.1 C.2
Airflow test 4.2.2 B.2 C.3
Airflow direction test and visualization 4.2.3 B.3 C.4
Recovery test 4.2.4 B.4 C.5
Temperature test 4.2.5 B.5 C.6
Humidity test 4.2.6 B.6 C.7
Installed filter system leakage test 4.2.7 B.7 C.8
Containment leak test 4.2.8 B.8 C.9
Electrostatic and ion generator tests 4.2.9 B.9 C.10
a
Particle deposition test 4.2.10 B.10 C.11
Segregation test 4.2.11 B.11 C.12
NOTE These supporting tests are not presented in order of importance or chronological order. The order in which tests
are performed can be based on the requirements of a specific document or after agreement between the customer and
supplier.
a
The particle deposition test can also be considered a test for cleanroom performance in the operational state.
4.2 Principle
4.2.1 Air pressure difference test
The purpose of the air pressure difference test is to verify the capability of the cleanroom air movement
system to maintain the specified pressure differential between the cleanroom and its surroundings.
The air pressure difference test should be performed after the cleanroom has met the acceptance
criteria for airflow velocity or air volume flow rate, uniformity of velocity and other applicable tests.
Details of the air pressure difference test are given in B.1.
4.2.2 Airflow test
This test is performed to measure the supply airflow introduced into both unidirectional and non-
unidirectional cleanrooms or clean zones. In unidirectional applications, the supply airflow velocity can
be measured with individual point readings to allow for the measurement of velocity and determination
of uniformity of velocity. The average of the individual velocity point readings may be used to calculate
the supply airflow volume and air change rate (air changes per hour). In non-unidirectional applications,
individual velocity point readings are typically not required as uniformity of velocity is generally
not necessary. In these cases, airflow volume readings may be measured directly and then used in
calculating the air change rate (air changes per hour) for the cleanroom or clean zone. Test procedures
for the airflow test are given in B.2.
ISO 14644-3:2019(E)
4.2.3 Airflow direction test and visualization
The purpose of this test is to demonstrate that the airflow direction and its uniformity of velocity
conform to the design and performance specifications. The airflow direction test can be conducted
in the at-rest state to determine the basic cleanroom airflow patterns and can be repeated in the
operational state simulating actual operations. Procedures for this test are given in B.3.
4.2.4 Recovery test
The recovery test is performed to determine whether the cleanroom or clean zone is capable of
returning to a specified cleanliness level within a finite time, after being exposed briefly to a source of
airborne particulate challenge. This test is not recommended for unidirectional airflow. The procedure
for this test is given in B.4. When an artificial aerosol is used, the risk of residue contamination of the
cleanroom or clean zone should be considered.
4.2.5 Temperature test
The purpose of this test is to verify the air temperature levels are within the control limits over the time
period specified by the customer for the area being tested. Procedures for these tests are given in B.5.
4.2.6 Humidity test
The purpose of this test is to verify moisture (expressed as relative humidity or dew point) levels are
within the control limits over the time period specified by the customer for the area being tested.
Procedures for these tests are given in B.6.
4.2.7 Installed filter system leakage tests
These tests are performed to confirm that the final high efficiency air filter system is properly installed
by verifying the absence of bypass leakage in the air filter installation, and that the filters are free of
defects (small holes and other damage in the filter medium, frame, seal and leaks in the filter bank
framework). These tests are not used to determine the efficiency of the filter medium. The tests are
performed by introducing an aerosol challenge upstream of the filters and scanning downstream of the
filters and support frame or sampling in a downstream duct. Leak detection methods are given in B.7.
4.2.8 Containment leak test
This test is performed to determine if there is intrusion of unfiltered air into the cleanroom or clean
zone(s) from outside the cleanroom or clean zone enclosure(s) through joints, seams, doorways and
pressurized ceilings. The procedure for this test is given in B.8.
4.2.9 Electrostatic and ion generator tests
The purpose of these tests is to evaluate electrostatic voltage levels on objects, static-dissipative
properties of materials and the performance of ion generators (i.e. ionizers) used for electrostatic
control in cleanrooms or clean zones. Electrostatic testing is performed to evaluate the electrostatic
voltage level on work and product surfaces, and the static dissipative properties of floors, workbench
tops, etc. The ion generator test is performed to evaluate the ionizer performance in eliminating static
charges on surfaces. Procedures for these tests are given in B.9.
4.2.10 Particle deposition test
The purpose of this test is to verify the quantity and size of particles deposited from the air in the
cleanroom onto a surface over an agreed period of time. Procedures for this test are given in B.10.
8 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
4.2.11 Segregation test
The purpose of this test is to assess the separation effectiveness achieved by a specific airflow,
challenging the lesser classified area with particles and determining the particle concentration in the
protected area at the other side of the segregation. Procedures for this test are given in B.11.
5 Test reports
The result of each test shall be recorded in a test report, and the test report shall include the following
information:
a) the name and address of the testing organization, and the date on which the test was performed;
b) a reference to this document (ISO 14644-3:2019);
c) clear identification of the physical location of the cleanroom or clean zone tested (including
reference to adjacent areas if necessary), and specific designations for coordinates of all sampling
locations;
d) the specified designation criteria for the cleanroom or clean zone, including the ISO classification,
the relevant occupancy state(s), and the considered particle size(s);
e) the details of the test method used, with any special conditions relating to the test or departures
from the test method, and identification of the test apparatus and its current calibration certificate;
f) the test result, including data reported as specifically required in the relevant clause of Annex B,
and a statement regarding compliance with the claimed designation;
g) any other specific requirements defined relevant to the clause of Annex B for particular tests.
ISO 14644-3:2019(E)
Annex A
(informative)
Choice of supporting tests and checklist
A.1 General
Special care should be taken when determining the sequence for carrying out tests for cleanroom, clean
zone or controlled zone performance.
The selection and sequence of tests should be determined between customer and supplier and should
detect noncompliance at the earliest stage possible and not compromise other tests in the sequence.
A.2 Test checklist
Table A.1 provides a checklist of tests and apparatus.
Table A.1 — Checklist of supporting tests
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Air pressure dif- B.1 Electronic micro- C.2.2
ference manometer
Inclined manometer C.2.3
Mechanical differen- C.2.4
tial pressure gauge
Airflow B.2 C.3
Uniformity of B.2.2.2 Thermal anemometer C.3.1.2
velocity within
Three-dimensional C.3.1.3
the cleanroom or
ultrasonic anemome-
clean zone (for
ter, or equivalent
unidirectional
Vane-type anemom- C.3.1.4
airflow)
eter
Tube array C.3.1.6
Supply airflow B.2.2.3 Thermal anemometer C.3.1.2
velocity (for
Three-dimensional C.3.1.3
unidirectional
ultrasonic anemome-
airflow)
ter, or equivalent
Vane-type anemom- C.3.1.4
eter
Tube array C.3.1.6
Supply air volume B.2.2.4 Thermal anemometer C.3.1.2
flow rate meas-
Three-dimensional C.3.1.3
ured by filter
ultrasonic anemome-
face velocity (for
ter, or equivalent
unidirectional
Vane-type anemom- C.3.1.4
airflow)
eter
Tube array C.3.1.6
10 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Table A.1 (continued)
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Supply air volume B.2.2.5 Orifice meter C.3.2.3
flow rate in air
Venturi meter C.3.2.4
ducts (for unidi-
Pitot-static tubes and C.3.1.5
rectional airflow)
manometer
Thermal anemometer C.3.1.2
Supply air volume B.2.3.2 Airflow capture hood C.3.2.2
flow rate meas- with measuring device
ured at the inlet
(for non- unidi-
rectional airflow
installation)
Supply air volume B.2.3.3 Thermal anemometer C.3.1.2
flow rate calcu-
Three-dimensional C.3.1.3
lated from filter
ultrasonic anemome-
face velocity (for
ter, or equivalent
non-unidirection-
Vane-type anemom- C.3.1.4
al airflow i)
eter
Supply air vol- B.2.3.4 Orifice meter C.3.2.3
ume flow rate
Venturi meter C.3.2.4
in air ducts (for
Pitot-static tubes and C.3.1.5
non-unidirection-
manometer
al airflow)
Thermal anemometer C.3.1.2
Airflow direction B.3 Tracers C.4.4.1
and visualization
Thermal anemometer C.4.2
Three-dimensional C.4.3
ultrasonic anemome-
ter, or equivalent
Aerosol generator C.4.4
Ultrasonic nebulizer C.4.4.2
Fog generator C.4.4.3
Recovery B.4 Light-scattering C.5.1
airborne-particle
counter (LSAPC
Aerosol generator C.5.2
Aerosol source sub- C.5.3
stances
Dilution system, C.5.4
equipment
Thermometer C.6
Temperature B.5 Expansion Thermom- C.6 a)
eter
Electrical Thermom- C.6 b)
eter
Thermomanometers C.6 c)
Humidity B.6 Dewpoint hygrometer C.7 a)
Electrical conductivity C.7 b)
variation hygrometer
ISO 14644-3:2019(E)
Table A.1 (continued)
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Installed filter B.7 C.8
system leakage
Installed filter B.7.2 Aerosol photometer C.8.1
system leakage
Aerosol generator C.8.3
scan test with an
Test aerosol source C.8.4
aerosol photom-
substances
eter
Installed filter sys- B.7.3 Light-scattering C.8.2
tem leakage scan airborne- particle
test with a LSAPC counter (LSAPC)
Aerosol generator C.8.3
Test aerosol source C.8.4
substances
Dilution system, C.8.5
equipment
Overall leak test B.7.4 Aerosol photometer C.8.1
of filters mount-
Light-scattering C.8.2
ed in ducts or
airborne- particle
air-handling units
counter (LSAPC)
Aerosol generator C.8.3
Test aerosol source C.8.4
substances
Dilution system, C.8.5
equipment (LSAPC
method only)
Containment leak B.8 C.9
Light-scattering B.8.2.1 Light-scattering C.9.1
airborne-particle airborne-particle
counter (LSAPC) counter (LSAPC)
method
Aerosol generator C.9.2
Test aerosol source C.9.3
substances
Dilution system, C.9.4
equipment
Aerosol photome- B.8.2.2 Aerosol generator C.9.2
ter method
Test aerosol source C.9.3
substances
Aerosol photometer C.9.5
Electrostatic and B.9 C.10
ion generator
Electrostatic B.9.2.1 Electrostatic voltme- C.10.1
ter
High r
...
SLOVENSKI STANDARD
01-januar-2020
Nadomešča:
SIST EN ISO 14644-3:2006
Čiste sobe in podobna nadzorovana okolja - 3. del: Preskusne metode (ISO 14644-
3:2019)
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-
3:2019)
Reinräume und zugehörige Reinraumbereiche - Teil 3: Prüfverfahren (ISO 14644-
3:2019)
Salles propres et environnements maîtrisés apparentés - Partie 3: Méthodes d'essai
(ISO 14644-3:2019)
Ta slovenski standard je istoveten z: EN ISO 14644-3:2019
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.
EN ISO 14644-3
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2019
EUROPÄISCHE NORM
ICS 13.040.35 Supersedes EN ISO 14644-3:2005
English Version
Cleanrooms and associated controlled environments - Part
3: Test methods (ISO 14644-3:2019)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil 3:
- Partie 3: Méthodes d'essai (ISO 14644-3:2019) Prüfverfahren (ISO 14644-3:2019)
This European Standard was approved by CEN on 24 July 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-3:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 14644-3:2019) has been prepared by Technical Committee ISO/TC 209
"Cleanrooms and associated controlled environments" in collaboration with Technical Committee
CEN/TC 243 “Cleanroom technology” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2020, and conflicting national standards shall be
withdrawn at the latest by April 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14644-3:2005.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 14644-3:2019 has been approved by CEN as EN ISO 14644-3:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-3
Second edition
2019-08
Cleanrooms and associated controlled
environments —
Part 3:
Test methods
Salles propres et environnements maîtrisés apparentés —
Partie 3: Méthodes d'essai
Reference number
ISO 14644-3:2019(E)
©
ISO 2019
ISO 14644-3:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Terms related to airborne particles . 3
3.3 Terms related to air filters and systems . 3
3.4 Terms related to airflow and other physical states . 4
3.5 Terms related to electrostatic measurement . 5
3.6 Terms related to measuring apparatus and measuring conditions . 5
3.7 Terms related to occupancy states . 6
4 Test procedures . 6
4.1 Cleanroom tests . 6
4.1.1 General. 6
4.1.2 Supporting tests . 7
4.2 Principle . 7
4.2.1 Air pressure difference test . 7
4.2.2 Airflow test . 7
4.2.3 Airflow direction test and visualization . 8
4.2.4 Recovery test . 8
4.2.5 Temperature test . 8
4.2.6 Humidity test . 8
4.2.7 Installed filter system leakage tests . 8
4.2.8 Containment leak test . . 8
4.2.9 Electrostatic and ion generator tests . 8
4.2.10 Particle deposition test . . 8
4.2.11 Segregation test . 9
5 Test reports . 9
Annex A (informative) Choice of supporting tests and checklist .10
Annex B (informative) Supporting test methods .14
Annex C (informative) Test apparatus .44
Bibliography .52
ISO 14644-3:2019(E)
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 ISO/TC 209, Cleanrooms and associated controlled environments.
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.
This second edition of ISO 14644-3 cancels and replaces the first edition (ISO 14644-3:2005), which has
been technically revised. The main changes compared to the previous edition are as follows:
— Clause B.7 has been simplified and corrected to address concerns over its complexity and noted errors;
— guidance concerning classification of air cleanliness by airborne particle concentration has been
[1]
moved to 14644-1
— the text of the whole document has been revised or clarified to aid in application.
A list of all parts in the ISO 14644 series can be found on the ISO website.
iv © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Introduction
Cleanrooms and associated controlled environments provide control of contamination to levels
appropriate for accomplishing contamination-sensitive activities. Products and processes that
benefit from the control of airborne contamination include those in such industries as aerospace,
microelectronics, pharmaceuticals, medical devices, healthcare and food.
This document sets out appropriate test methods for measuring the performance of a cleanroom, a
clean zone or an associated controlled environment, including separative devices and controlled zones,
together with all associated structures, air treatment systems, services and utilities.
NOTE Not all cleanroom parameter test procedures are shown in this document. The procedure and
apparatus for the test carried out for the air cleanliness classes by particle concentration and for macroparticles
[1]
are provided in ISO 14644-1, and specifications for monitoring air cleanliness by nanoscale particle
[8]
concentrations are provided in ISO 14644-12. The procedures and apparatus to characterize other parameters,
of concern in cleanrooms and clean zones used for specific products or processes, are discussed elsewhere
in other documents prepared by ISO/TC 209 [for example, procedures for control and measurement of viable
[3]
materials (ISO 14698 series), testing cleanroom functionality (ISO 14644-4 ), and testing of separative devices
[4]
(ISO 14644-7 )]. In addition, other standards can be considered to be applicable. Other cleanliness attribute
[5] [6]
levels can be determined using ISO 14644-8 (levels of air cleanliness by chemicals), ISO 14644-9 (levels
[7]
of surface cleanliness by particle concentration) and ISO 14644-10 (levels of surface cleanliness by chemical
concentration).
INTERNATIONAL STANDARD ISO 14644-3:2019(E)
Cleanrooms and associated controlled environments —
Part 3:
Test methods
1 Scope
This document provides test methods in support of the operation for cleanrooms and clean zones to
meet air cleanliness classification, other cleanliness attributes and related controlled conditions.
Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional
airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest
and operational.
The test methods, recommended test apparatus and test procedures for determining performance
parameters are provided. Where the test method is affected by the type of cleanroom or clean zone,
alternative procedures are suggested.
For some of the tests, several different methods and apparatus are recommended to accommodate
different end-use considerations. Alternative methods not included in this document can be used by
agreement between customer and supplier. Alternative methods do not necessarily provide equivalent
measurements.
This document is not applicable to the measurement of products or of processes in cleanrooms, clean
zones or separative devices.
NOTE This document does not purport to address safety considerations associated with its use (for example,
when using hazardous materials, operations and equipment). It is the responsibility of the user of this document
to establish appropriate safety and health practices and to determine the applicability of regulatory limitations
prior to use.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1 General terms
3.1.1
cleanroom
room within which the number concentration of airborne particles (3.2.1) 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 (3.2.4) is specified.
ISO 14644-3:2019(E)
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]
3.1.2
clean zone
defined space within which the number concentration of airborne particles (3.2.1) 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 (3.2.4) 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 (3.1.1) 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]
3.1.3
installation
cleanroom (3.1.1) or one or more clean zones (3.1.2), together with all associated structures, air-
treatment systems, services and utilities
[SOURCE: ISO 14644-1:2015, 3.1.3]
3.1.4
separative device
equipment utilizing constructional and dynamic means to create assured levels of separation between
the inside and outside of a defined volume
Note 1 to entry: Some industry-specific examples of separative devices are clean air hoods, containment
enclosures, glove boxes, isolators and mini-environments.
[SOURCE: ISO 14644-7:2004, 3.17]
3.1.5
resolution
smallest change in a quantity being measured that causes a perceptible change in the corresponding
indication
Note 1 to entry: Resolution can depend on, for example, noise (internal or external) or friction. It may also depend
on the value of a quantity being measured.
[SOURCE: ISO 14644-1:2015, 3.4.1]
3.1.6
sensitivity
quotient of the change in an indication of a measuring system and the corresponding change in a value
of the quantity being measured
2 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
3.2 Terms related to airborne particles
3.2.1
airborne particle
solid or liquid object suspended in air, viable or non-viable, sized between 1 nm and 100 µm
Note 1 to entry: For classification purposes, refer to ISO 14644-1:2015, 3.2.1.
3.2.2
count median particle diameter
median particle diameter based on the number of particles
Note 1 to entry: For the count median, one half of the particle number is contributed by the particles with a size
smaller than the count median size, and one half by particles larger than the count median size.
3.2.3
mass median particle diameter
median particle diameter based on the particle mass
Note 1 to entry: For the mass median, one half of mass of all particles is contributed by particles with a size
smaller than the mass median size, and one half by particles larger than the mass median size.
3.2.4
particle concentration
number of individual particles per unit volume of air
[SOURCE: ISO 14644-1:2015, 3.2.3]
3.2.5
particle size
diameter of a sphere that produces a response, by a given particle-sizing instrument, that is equivalent
to the response produced by the particle being measured
Note 1 to entry: For light-scattering airborne-particle instruments, the equivalent optical diameter is used.
[SOURCE: ISO 14644-1:2015, 3.2.2]
3.2.6
particle size distribution
cumulative distribution of particle concentration (3.2.4) as a function of particle size (3.2.5)
[SOURCE: ISO 14644-1:2015, 3.2.4]
3.2.7
test aerosol
gaseous suspension of solid and/or liquid particles with known and controlled size distribution and
concentration
3.3 Terms related to air filters and systems
3.3.1
aerosol challenge
challenging of a filter or an installed filter system (3.3.6) by test aerosol (3.2.7)
3.3.2
designated leak
maximum allowable penetration, which is determined by agreement between customer and supplier,
through a leak (3.3.8), detectable during scanning (3.3.9) of a filter installation (3.1.3) with light-
scattering airborne-particle counters (LSAPC) or aerosol photometers (3.6.2)
ISO 14644-3:2019(E)
3.3.3
dilution system
system wherein aerosol is mixed with particle-free dilution air in a known volumetric ratio to reduce
concentration
3.3.4
filter system
assembly composed of filter, frame and other support mechanism or other housing
3.3.5
final filter
filter in a final position before the air enters the cleanroom (3.1.1) or clean zone (3.1.2)
3.3.6
installed filter system
filter system (3.3.4) mounted in the ceiling, wall, apparatus or duct
3.3.7
installed filter system leakage test
test performed to confirm that the filters are properly installed by verifying that there is absence of
bypass leakage of the filter installation (3.1.3), and that the filters and the grid system are free of defects
and leaks (3.3.8)
3.3.8
leak
penetration of contaminants that exceed an expected value of downstream
concentration through lack of integrity or defects
3.3.9
scanning
method for disclosing leaks (3.3.8) in filters and parts of units, whereby the probe inlet of an aerosol
photometer (3.6.2) or a light-scattering airborne-particle counter is moved in overlapping strokes
across the defined test area
3.4 Terms related to airflow and other physical states
3.4.1
air change rate
air exchange rate
rate expressing number of air changes per unit of time and calculated by dividing the volume of air
delivered in the unit of time by the volume of the cleanroom (3.1.1) or clean zone (3.1.2)
3.4.2
measuring plane
cross-sectional area for testing or measuring a performance parameter such as the airflow velocity
3.4.3
non-unidirectional airflow
air distribution where the supply air entering the cleanroom (3.1.1) or clean zone (3.1.2) mixes with the
internal air by means of induction
[SOURCE: ISO 14644-1:2015, 3.2.8]
3.4.4
supply air volume flow rate
air volume per unit of time supplied into a cleanroom (3.1.1) or clean zone (3.1.2) from final filters (3.3.5)
or air ducts
4 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
3.4.5
total air volume flow rate
air volume per unit of time that passes through a section of a cleanroom (3.1.1) or clean zone (3.1.2)
3.4.6
unidirectional airflow
controlled airflow through the entire cross-section of a cleanroom (3.1.1) or a clean zone (3.1.2) with a
steady velocity and airstreams that are considered to be parallel
[SOURCE: ISO 14644-1:2015, 3.2.7]
3.4.7
uniformity of velocity
unidirectional airflow (3.4.6) pattern in which the point-to-point readings of velocity (speed and
direction of airflow) are within a defined percentage of the average airflow velocity
3.5 Terms related to electrostatic measurement
3.5.1
discharge time
time required to reduce the voltage to the level, positive or negative, to which an isolated conductive
monitoring plate was originally charged
3.5.2
offset voltage
voltage that accumulates on an initially uncharged isolated conductive plate when that plate is exposed
to an ionized air environment
3.5.3
static-dissipative property
capability for reducing electrostatic charge on work or product surface, as a result of conduction or
other mechanism to a specific value or nominal zero charge level
3.5.4
surface voltage level
positive or negative voltage level of electrostatic charging on work or product surface, as indicated by
use of suitable apparatus
3.6 Terms related to measuring apparatus and measuring conditions
3.6.1
aerosol generator
apparatus capable of generating particulate matter having appropriate size range (e.g. 0,05 µm to
2 µm) at a constant concentration, which can be produced by thermal, hydraulic, pneumatic, acoustic or
electrostatic means
3.6.2
aerosol photometer
light-scattering airborne particle (3.2.1) mass concentration measuring apparatus, which uses a
forward-scattered-light optical chamber to make measurements
3.6.3
airflow capture hood with measuring device
device with apparatus to completely cover the filter or air diffuser, and collect the air to directly
measure the air volume flow rate
ISO 14644-3:2019(E)
3.6.4
LSAPC
light scattering airborne particle counter
apparatus capable of counting and sizing single airborne particles (3.2.1) and reporting size data in
terms of equivalent optical diameter
Note 1 to entry: The specifications for a particle counter are given in ISO 21501-4.
[SOURCE: ISO 14644-1:2015, 3.5.1, modified — The term "light scattering discrete airborne particle
counter" has been removed. Note 1 to entry has been reworded.]
3.6.5
witness plate
material of defined surface area used in lieu of direct evaluation of a specific surface that is either
inaccessible or too sensitive to be handled
3.7 Terms related to occupancy states
3.7.1
as-built
condition where the cleanroom (3.1.1) or clean zone (3.1.2) is complete with all services connected and
functioning but with no equipment, furniture, materials or personnel present
[SOURCE: ISO 14644-1:2015, 3.3.1]
3.7.2
at-rest
condition where the cleanroom (3.1.1) or clean zone (3.1.2) is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present
[SOURCE: ISO 14644-1:2015, 3.3.2]
3.7.3
operational
agreed condition where the cleanroom (3.1.1) or clean zone (3.1.2) is functioning in the specified
manner, with equipment operating and with the specified number of personnel present
[SOURCE: ISO 14644-1:2015, 3.3.3]
4 Test procedures
4.1 Cleanroom tests
4.1.1 General
[1]
ISO 14644-1 shall be carried out in order to classify a cleanroom or clean zone by airborne particle
concentration. Additional cleanliness attributes should be chosen if required (see Table 1).
NOTE Each standard contains specifications for test methods based on the characteristics of specific
attributes, guidance on evaluating the test data and specifications for test apparatus.
Table 1 — Cleanliness attribute tests for cleanrooms and clean zones
General description Referenced in
[6]
Levels of surface cleanliness by particle concentration ISO 14644-9
[5]
Levels of air cleanliness by chemical concentration ISO 14644-8
[7]
Levels of surface cleanliness by chemical concentration ISO 14644-10
[8]
Monitoring air cleanliness by nanoscale particle concentration ISO 14644-12
6 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
4.1.2 Supporting tests
Table 2 lists other appropriate tests that can be used for measuring the performance of a cleanroom or
clean zone installation. These tests may be applied in each of the three designated occupancy states;
refer to details in Annex B for suggested applications. These tests may not be all-inclusive. Also, they
may not all be required for any given project. Tests and test methods should be selected in a manner
agreed between the customer and supplier. Selected tests can also be repeated on a regular basis as
part of routine monitoring or periodic testing. Guidelines for the selection of tests and a checklist of
tests are given in Annex A. Test methods are outlined in Annex B.
NOTE The test methods described in Annex B are in outline form only. Specific methods can be developed to
meet the needs of the particular application.
Table 2 — Supporting tests
Reference in ISO 14644-3
Supporting tests
Principle Procedure Apparatus
Air pressure difference test 4.2.1 B.1 C.2
Airflow test 4.2.2 B.2 C.3
Airflow direction test and visualization 4.2.3 B.3 C.4
Recovery test 4.2.4 B.4 C.5
Temperature test 4.2.5 B.5 C.6
Humidity test 4.2.6 B.6 C.7
Installed filter system leakage test 4.2.7 B.7 C.8
Containment leak test 4.2.8 B.8 C.9
Electrostatic and ion generator tests 4.2.9 B.9 C.10
a
Particle deposition test 4.2.10 B.10 C.11
Segregation test 4.2.11 B.11 C.12
NOTE These supporting tests are not presented in order of importance or chronological order. The order in which tests
are performed can be based on the requirements of a specific document or after agreement between the customer and
supplier.
a
The particle deposition test can also be considered a test for cleanroom performance in the operational state.
4.2 Principle
4.2.1 Air pressure difference test
The purpose of the air pressure difference test is to verify the capability of the cleanroom air movement
system to maintain the specified pressure differential between the cleanroom and its surroundings.
The air pressure difference test should be performed after the cleanroom has met the acceptance
criteria for airflow velocity or air volume flow rate, uniformity of velocity and other applicable tests.
Details of the air pressure difference test are given in B.1.
4.2.2 Airflow test
This test is performed to measure the supply airflow introduced into both unidirectional and non-
unidirectional cleanrooms or clean zones. In unidirectional applications, the supply airflow velocity can
be measured with individual point readings to allow for the measurement of velocity and determination
of uniformity of velocity. The average of the individual velocity point readings may be used to calculate
the supply airflow volume and air change rate (air changes per hour). In non-unidirectional applications,
individual velocity point readings are typically not required as uniformity of velocity is generally
not necessary. In these cases, airflow volume readings may be measured directly and then used in
calculating the air change rate (air changes per hour) for the cleanroom or clean zone. Test procedures
for the airflow test are given in B.2.
ISO 14644-3:2019(E)
4.2.3 Airflow direction test and visualization
The purpose of this test is to demonstrate that the airflow direction and its uniformity of velocity
conform to the design and performance specifications. The airflow direction test can be conducted
in the at-rest state to determine the basic cleanroom airflow patterns and can be repeated in the
operational state simulating actual operations. Procedures for this test are given in B.3.
4.2.4 Recovery test
The recovery test is performed to determine whether the cleanroom or clean zone is capable of
returning to a specified cleanliness level within a finite time, after being exposed briefly to a source of
airborne particulate challenge. This test is not recommended for unidirectional airflow. The procedure
for this test is given in B.4. When an artificial aerosol is used, the risk of residue contamination of the
cleanroom or clean zone should be considered.
4.2.5 Temperature test
The purpose of this test is to verify the air temperature levels are within the control limits over the time
period specified by the customer for the area being tested. Procedures for these tests are given in B.5.
4.2.6 Humidity test
The purpose of this test is to verify moisture (expressed as relative humidity or dew point) levels are
within the control limits over the time period specified by the customer for the area being tested.
Procedures for these tests are given in B.6.
4.2.7 Installed filter system leakage tests
These tests are performed to confirm that the final high efficiency air filter system is properly installed
by verifying the absence of bypass leakage in the air filter installation, and that the filters are free of
defects (small holes and other damage in the filter medium, frame, seal and leaks in the filter bank
framework). These tests are not used to determine the efficiency of the filter medium. The tests are
performed by introducing an aerosol challenge upstream of the filters and scanning downstream of the
filters and support frame or sampling in a downstream duct. Leak detection methods are given in B.7.
4.2.8 Containment leak test
This test is performed to determine if there is intrusion of unfiltered air into the cleanroom or clean
zone(s) from outside the cleanroom or clean zone enclosure(s) through joints, seams, doorways and
pressurized ceilings. The procedure for this test is given in B.8.
4.2.9 Electrostatic and ion generator tests
The purpose of these tests is to evaluate electrostatic voltage levels on objects, static-dissipative
properties of materials and the performance of ion generators (i.e. ionizers) used for electrostatic
control in cleanrooms or clean zones. Electrostatic testing is performed to evaluate the electrostatic
voltage level on work and product surfaces, and the static dissipative properties of floors, workbench
tops, etc. The ion generator test is performed to evaluate the ionizer performance in eliminating static
charges on surfaces. Procedures for these tests are given in B.9.
4.2.10 Particle deposition test
The purpose of this test is to verify the quantity and size of particles deposited from the air in the
cleanroom onto a surface over an agreed period of time. Procedures for this test are given in B.10.
8 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
4.2.11 Segregation test
The purpose of this test is to assess the separation effectiveness achieved by a specific airflow,
challenging the lesser classified area with particles and determining the particle concentration in the
protected area at the other side of the segregation. Procedures for this test are given in B.11.
5 Test reports
The result of each test shall be recorded in a test report, and the test report shall include the following
information:
a) the name and address of the testing organization, and the date on which the test was performed;
b) a reference to this document (ISO 14644-3:2019);
c) clear identification of the physical location of the cleanroom or clean zone tested (including
reference to adjacent areas if necessary), and specific designations for coordinates of all sampling
locations;
d) the specified designation criteria for the cleanroom or clean zone, including the ISO classification,
the relevant occupancy state(s), and the considered particle size(s);
e) the details of the test method used, with any special conditions relating to the test or departures
from the test method, and identification of the test apparatus and its current calibration certificate;
f) the test result, including data reported as specifically required in the relevant clause of Annex B,
and a statement regarding compliance with the claimed designation;
g) any other specific requirements defined relevant to the clause of Annex B for particular tests.
ISO 14644-3:2019(E)
Annex A
(informative)
Choice of supporting tests and checklist
A.1 General
Special care should be taken when determining the sequence for carrying out tests for cleanroom, clean
zone or controlled zone performance.
The selection and sequence of tests should be determined between customer and supplier and should
detect noncompliance at the earliest stage possible and not compromise other tests in the sequence.
A.2 Test checklist
Table A.1 provides a checklist of tests and apparatus.
Table A.1 — Checklist of supporting tests
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Air pressure dif- B.1 Electronic micro- C.2.2
ference manometer
Inclined manometer C.2.3
Mechanical differen- C.2.4
tial pressure gauge
Airflow B.2 C.3
Uniformity of B.2.2.2 Thermal anemometer C.3.1.1
velocity within
Three-dimensional C.3.1.2
the cleanroom or
ultrasonic anemome-
clean zone (for
ter, or equivalent
unidirectional
Vane-type anemom- C.3.1.3
airflow)
eter
Tube array C.3.1.5
Supply airflow B.2.2.3 Thermal anemometer C.3.1.1
velocity (for
Three-dimensional C.3.1.2
unidirectional
ultrasonic anemome-
airflow)
ter, or equivalent
Vane-type anemom- C.3.1.3
eter
Tube array C.3.1.5
Supply air volume B.2.2.4 Thermal anemometer C.3.1.1
flow rate meas-
Three-dimensional C.3.1.2
ured by filter
ultrasonic anemome-
face velocity (for
ter, or equivalent
unidirectional
Vane-type anemom- C.3.1.3
airflow)
eter
Tube array C.3.1.5
10 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Table A.1 (continued)
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Supply air volume B.2.2.5 Orifice meter C.3.2.3
flow rate in air
Venturi meter C.3.2.4
ducts (for unidi-
Pitot-static tubes and C.3.1.4
rectional airflow)
manometer
Thermal anemometer C.3.1.1
Supply air volume B.2.3.2 Airflow capture hood C.3.2.2
flow rate meas- with measuring device
ured at the inlet
(for non- unidi-
rectional airflow
installation)
Supply air volume B.2.3.3 Thermal anemometer C.3.1.1
flow rate calcu-
Three-dimensional C.3.1.2
lated from filter
ultrasonic anemome-
face velocity (for
ter, or equivalent
non-unidirection-
Vane-type anemom- C.3.1.3
al airflow i)
eter
Supply air vol- B.2.3.4 Orifice meter C.3.2.3
ume flow rate
Venturi meter C.3.2.4
in air ducts (for
Pitot-static tubes and C.3.1.4
non-unidirection-
manometer
al airflow)
Thermal anemometer C.3.1.1
Airflow direction B.3 Tracers C.4.4.1
and visualization
Thermal anemometer C.4.2
Three-dimensional C.4.3
ultrasonic anemome-
ter, or equivalent
Aerosol generator C.4.4
Ultrasonic nebulizer C.4.4.2
Fog generator C.4.4.3
Recovery B.4 Light-scattering C.5.1
airborne-particle
counter (LSAPC
Aerosol generator C.5.2
Aerosol source sub- C.5.3
stances
Dilution system, C.5.4
equipment
Thermometer C.6
Temperature B.5 Expansion Thermom- C.6 a)
eter
Electrical Thermom- C.6 b)
eter
Thermomanometers C.6 c)
Humidity B.6 Dewpoint hygrometer C.7 a)
Electrical conductivity C.7 b)
variation hygrometer
ISO 14644-3:2019(E)
Table A.1 (continued)
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Installed filter B.7 C.8
system leakage
Installed filter B.7.2 Aerosol photometer C.8.1
system leakage
Aerosol generator C.8.3
scan test with an
Test aerosol source C.8.4
aerosol photom-
substances
eter
Installed filter sys- B.7.3 Light-scattering C.8.2
tem leakage scan airborne- particle
test with a LSAPC counter (LSAPC)
Aerosol generator C.8.3
Test aerosol source C.8.4
substances
Dilution system, C.8.5
equipment
Overall leak test B.7.4 Aerosol photometer C.8.1
of filters mount-
Light-scattering C.8.2
ed in ducts or
airborne- particle
air-handling units
counter (LSAPC)
Aerosol generator C.8.3
Test aerosol source C.8.4
substances
Dilution system, C.8.5
equipment (LSAPC
method only)
Containment leak B.8 C.9
Light-scattering B.8.2.1 Light-scattering C.9.1
airborne-particle airborne-particle
counter (LSAPC) counter (LSAPC)
method
Aerosol generator C.9.2
Test aerosol source C.9.3
substances
Dilution system, C.9.4
equipment
Aerosol photome- B.8.2.2 Aerosol generator C.9.2
ter method
Test aerosol source C.9.3
substances
Aerosol photometer C.9.5
Electrostatic and B.9 C.10
ion generator
Electrostatic B.9.2.1 Electrostatic voltme- C.10.1
ter
High resistance ohm- C.10.2
meter
Charged plate monitor C.10.3
12 © ISO 2019 – All rights reserved
ISO 14644-3:2019(E)
Table A.1 (continued)
Selection of Test procedure Test pro- Selection Test apparatus Apparatus Comments
test procedure cedure of test ap- reference
a b
and sequence reference paratus
Ion generator B.9.2.2 Electrostatic voltme- C.10.1
ter
High resistance ohm- C.10.2
meter
Charged plate monitor C.10.3
Particle deposition B.10 Witness plate material C.11.1
Wafer surface scanner C.11.2
Particle fallout aero- C.11.3
sol
...
Frequently Asked Questions
SIST EN ISO 14644-3:2020 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)". This standard covers: This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational. The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices. NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions. Performance tests are specified for two types of cleanrooms and clean zones: those with unidirectional airflow and those with non-unidirectional airflow, in three possible occupancy states: as-built, at-rest and operational. The test methods, recommended test apparatus and test procedures for determining performance parameters are provided. Where the test method is affected by the type of cleanroom or clean zone, alternative procedures are suggested. For some of the tests, several different methods and apparatus are recommended to accommodate different end-use considerations. Alternative methods not included in this document can be used by agreement between customer and supplier. Alternative methods do not necessarily provide equivalent measurements. This document is not applicable to the measurement of products or of processes in cleanrooms, clean zones or separative devices. NOTE This document does not purport to address safety considerations associated with its use (for example, when using hazardous materials, operations and equipment). It is the responsibility of the user of this document to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.
SIST EN ISO 14644-3:2020 is classified under the following ICS (International Classification for Standards) categories: 13.040.35 - Cleanrooms and associated controlled environments. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 14644-3:2020 has the following relationships with other standards: It is inter standard links to SIST EN ISO 14644-3:2006, SIST EN ISO 14644-3:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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SIST EN ISO 14644-3:2020은 청정실 및 관련 제어 환경에 대한 테스트 방법을 제공하는 표준으로, 공기 청정도 분류, 기타 청정 속성 및 관련 제어 조건을 충족하기 위한 운영 지원을 목적으로 합니다. 이 표준의 주요 강점은 청정실 및 청정 구역을 위해 정의된 성능 테스트 방법이 유일한 방향성 공기 흐름을 가지는 청정실과 비유일적인 방향성 공기 흐름을 가지는 청정실 두 가지 유형에 대해 세분화되어 있다는 점입니다. 세 가지 점유 상태인 구축 상태, 휴식 상태 및 운영 상태에 따라 테스트를 수행할 수 있는 방법을 명시하고 있습니다. 이 문서는 성능 파라미터를 결정하기 위한 추천 테스트 장비 및 절차를 제공하며, 청정실 또는 청정 구역의 유형에 따라 테스트 방법이 영향을 받을 때 대체 절차를 제시합니다. 특정 테스트의 경우, 다양한 최종 사용 고려 사항을 수용하기 위해 여러 다른 방법과 장비를 추천하고 있습니다. 고객과 공급자 간의 합의가 있을 경우, 문서에 포함되지 않은 대체 방법을 사용할 수 있으나, 이러한 대체 방법이 반드시 동등한 측정을 제공하는 것은 아닙니다. 또한, SIST EN ISO 14644-3:2020 문서는 청정실, 청정 구역 또는 분리 장치 내 제품이나 프로세스의 측정에는 적용되지 않으며, 안전 고려사항을 다루고 있지 않음을 명확히 하고 있습니다. 사용자에게는 적절한 안전 및 건강 관행을 수립할 책임이 있으며, 사용 전에 규제 제한의 적용 가능성을 확인하는 것도 중요합니다. 이 표준은 청정실 운영의 일관성과 신뢰성을 보장하기 위한 주요 기준을 제공하며, 청정 환경을 유지하기 위한 표준화된 테스트 방법론을 통해 연구 및 산업 분야에서의 응용 가능성을 크게 확장합니다.
SIST EN ISO 14644-3:2020は、クリーンルームおよび関連する制御環境におけるテスト方法についての重要な標準であり、特に空気の清浄度分類やその他の清浄性属性、関連する制御条件を満たすための運用を支援する役割を果たしています。この標準は、ユニダイレクショナルフローとノンユニダイレクショナルフローの二種類のクリーンルームおよびクリーンゾーンの性能テストを規定しており、実際の設計状態、静止状態、運用状態の三つの占有状態における検査が可能です。 この標準の強みは、具体的な性能パラメータを決定するためのテスト方法、推奨されるテスト装置、およびテスト手順を詳細に提供している点です。また、クリーンルームやクリーンゾーンの種類に応じて異なる手順を示唆することで、多様なニーズに対応できる柔軟性を持っています。さらに、一部のテストにおいては、様々なエンドユースの考慮に応じて複数の異なる方法と装置を推奨しているため、利用者は自身の特定の条件に最適なアプローチを選択できるという利点があります。 しかし、重要なのは、この文書がクリーンルーム、クリーンゾーン、または分離装置における製品やプロセスの測定には適用されないことです。使用者は、使用する際の安全性および健康に関する適切な慣行を確立し、規制の制約を考慮する責任があります。これにより、標準の適切な適用が促進され、産業界におけるクリーンルーム環境の品質保証に寄与しています。
The SIST EN ISO 14644-3:2020 standard is a comprehensive document that delineates crucial test methods essential for maintaining the operational integrity of cleanrooms and controlled environments. Its scope is expressly focused on ensuring that these environments can meet prescribed air cleanliness classifications and cleanliness attributes while adhering to specified controlled conditions. One of the notable strengths of this standard is its detailed categorization of performance tests tailored to two distinct types of cleanrooms: those utilizing unidirectional airflow and those employing non-unidirectional airflow. By addressing these different airflow types, the document captures a wide array of operational settings, thus enhancing its relevance to various industries involved in cleanroom operations. Furthermore, the standard accounts for three different occupancy states-as-built, at-rest, and operational-allowing for a nuanced understanding of how cleanrooms perform under different conditions. The provision of recommended test apparatus and procedures is another significant advantage of the SIST EN ISO 14644-3:2020. This includes a range of methods, which affords flexibility for users to adapt testing to their specific needs while considering varied end-use requirements. By suggesting alternative procedures where conventional methods may not be adequate due to the type of cleanroom or clean zone, the standard not only enhances testing versatility but also supports the critical requirement for precision in cleanroom management. Moreover, the document's acknowledgment of the potential for alternative methods, although not exhaustively covered, emphasizes a collaborative approach between customers and suppliers to satisfy specific testing needs. However, it's crucial to note that alternative methods might not yield equivalent measurement outcomes, which underscores the importance of adhering to the prescribed methodologies where provided. One limitation worth noting is that the document specifically excludes the measurement of products or processes occurring within cleanrooms, clean zones, or separative devices. This specificity reinforces the focus on operational conditions rather than on product validation, which may be an important consideration for users seeking comprehensive testing protocols. Overall, the SIST EN ISO 14644-3:2020 standard serves as a pivotal resource within the realm of cleanroom operation, providing clarity on test methods that are essential for compliance with air cleanliness and associated cleanroom attributes. Its structured approach, combined with flexibility in testing, affirms its significance in the maintenance of controlled environments across various industries.
SIST EN ISO 14644-3:2020 표준은 클린룸 및 관련 제어 환경에서의 작동 지원을 위한 시험 방법을 제공합니다. 이 문서의 범위는 공기 청정도 분류 및 기타 청결 특성과 관련된 제어 조건을 충족하기 위한 것입니다. 특히, 이 표준은 단방향 공기 흐름을 가진 클린룸과 비단방향 공기 흐름을 가진 클린룸을 위한 성능 시험을 제시하며, 세 가지 점유 상태: 설계 완료, 정지 상태 및 운영 상태에서 적용됩니다. 이 표준의 강점 중 하나는 다양한 성능 매개변수를 결정하기 위한 추천 시험 장비 및 절차를 포함하고 있다는 점입니다. 클린룸 또는 클린 존의 유형에 영향을 받는 시험 방법에 대해서는 대체 절차를 제시하여 유연성을 제공합니다. 또한, 특정 테스트에 대해 여러 가지 다른 방법과 장비를 추천하여 다양한 최종 용도 고려 사항에 부합하도록 합니다. 고객과 공급자 간의 합의 하에 포함되지 않은 대체 방법을 사용할 수 있으나, 이 경우 동등한 측정을 보장하지는 않습니다. 이 문서는 클린룸, 클린 존 또는 분리 장치에서 제품이나 프로세스의 측정에는 적용되지 않습니다. 또한, 이 문서는 안전성을 다루지 않으며, 사용자는 문서 사용 전에 적절한 안전 및 건강 관행을 확립하고 규제 제한 사항의 적용 가능성을 결정할 책임이 있습니다. 이로 인해, SIST EN ISO 14644-3:2020 표준은 클린룸 운영에 필요한 시험 방법의 명확한 지침을 제공함으로써 산업에서의 청결 기준을 유지하고 향상시키는 데 매우 중요한 역할을 합니다.
The SIST EN ISO 14644-3:2020 standard is pivotal for ensuring the operational effectiveness of cleanrooms and associated controlled environments. Its comprehensive scope focuses on providing test methods that support air cleanliness classification and other cleanliness attributes, critical for maintaining controlled conditions. One of the strengths of this standard lies in its detailed performance tests tailored for two specific types of cleanrooms: those characterized by unidirectional airflow and those with non-unidirectional airflow. By addressing three critical occupancy states-namely as-built, at-rest, and operational-it allows for a robust assessment of cleanroom performance under various conditions. This multifaceted approach ensures that facilities can accurately gauge their cleanliness standards based on real operational scenarios. Furthermore, the standard shines in its provision of recommended test apparatus and procedures, which facilitate the determination of essential performance parameters. This clarity helps streamline the testing process, ensuring consistency across different environments and applications. Importantly, the inclusion of alternative procedures for tests influenced by the cleanroom type reflects the adaptability of the standard, accommodating diverse end-user needs and enhancing relevance in varied operational contexts. Another notable feature is the standard's allowance for alternative methods that may not be explicitly included, showcasing a flexible approach to testing. This aspect underscores the document's commitment to facilitating negotiation between customers and suppliers, allowing for tailored solutions while cautioning that not all alternative methods will yield equivalent measurements. However, it is essential to note the explicit limitation regarding the standard's applicability. While it provides comprehensive testing methodologies for cleanrooms, it does not extend its scope to measuring products or processes within those environments or related separative devices. This specificity helps to focus the standard on the core objective of maintaining and evaluating cleanliness in controlled environments. Overall, the SIST EN ISO 14644-3:2020 standard is highly relevant to industries reliant on precise environmental controls. Its structured approach not only enhances operational standards in cleanrooms but also encourages best practices in air cleanliness classification and cleanliness attributes.
Le document SIST EN ISO 14644-3:2020 est un guide essentiel pour les opérations au sein des salles blanches et des environnements contrôlés, en offrant des méthodes de test précises pour garantir la classification de la propreté de l'air et d'autres attributs de propreté. Son champ d'application est vaste, couvrant spécifiquement les salles blanches avec flux d'air unidirectionnel et non unidirectionnel, tout en tenant compte de trois états d'occupation : construit, au repos et opérationnel. Parmi les points forts de cette norme, on note la diversité des méthodes de test recommandées et des appareils de test suggérés pour estimer les paramètres de performance. Cette flexibilité permet d'adapter les méthodes aux besoins spécifiques des différents environnements contrôlés. De plus, la norme indique des procédures alternatives pour les cas où la méthode de test varie selon le type de salle blanche, garantissant ainsi une approche cohérente lors des évaluations de performance. L'aspect pertinent de ce document réside également dans sa capacité à intégrer plusieurs méthodes et appareils pour certains tests, ce qui facilite la prise en compte de diverses considérations d'utilisation finale. Il est essentiel de reconnaître que des méthodes alternatives, bien que non incluses dans le document, peuvent être mises en place par accord entre le client et le fournisseur, bien que cela n'assure pas nécessairement des mesures équivalentes. Cependant, il est crucial de souligner que la norme ne s'applique pas à la mesure des produits ou des processus au sein des salles blanches, des zones propres ou des dispositifs de séparation. De plus, le document ne traite pas des considérations de sécurité liées à son utilisation, ce qui en fait une responsabilité individuelle pour l'utilisateur d'établir des pratiques de sécurité appropriées. En résumé, le SIST EN ISO 14644-3:2020 se présente comme un outil fondamental pour ceux qui opèrent dans le domaine des salles blanches et des environnements contrôlés, en assurant une classification et des tests de propreté de l'air fiables et pertinents.
SIST EN ISO 14644-3:2020は、クリーンルームおよび関連する制御環境における試験方法を提供する重要な標準です。特に、空気の清浄度分類やその他の清浄特性、関連する制御条件を満たすための運用を支援するための試験方法が詳述されています。この標準は、単一方向の気流を持つクリーンルームや非単一方向の気流を持つクリーンゾーンの2種類を対象としており、それぞれの occupancy 状態（構築時、静止時、稼働時）におけるパフォーマンステストが定義されています。 この文書の強みは、多様な試験方法、推奨試験装置、および性能パラメータを決定するための手順が提供されている点です。クリーンルームまたはクリーンゾーンの種類に影響される試験方法に対しては、代替手順が提案されているため、さまざまな環境条件に対応した柔軟性があります。また、いくつかの試験に関しては、異なる最終使用に関する考慮を考慮した複数の方法や装置が推奨されていることも特筆すべき点です。 ただし、この標準は、クリーンルーム、クリーンゾーン、または分離デバイス内の製品やプロセスの測定には適用されないことに注意が必要です。また、安全性の考慮（例えば、危険物質の使用に関連するもの）に関しては、本標準が必ずしも触れていないため、使用者が適切な安全衛生慣行を確立し、法規制の適用性を判断する責任があります。 全体として、SIST EN ISO 14644-3:2020は、クリーンルームおよびクリーンゾーンの運用におけるテスト方法を標準化することで、品質管理と運用効率の向上に貢献する重要な文書であり、その関連性は非常に高いものです。
Die Norm SIST EN ISO 14644-3:2020 bietet umfassende Testmethoden zur Unterstützung des Betriebs von Reinräumen und kontrollierten Umgebungen, um die Anforderungen an die Luftreinheitsklassifikation sowie andere Reinheitsattribute und damit verbundene kontrollierte Bedingungen zu erfüllen. Der Umfang der Norm ist klar definiert und umfasst zwei Typen von Reinräumen und Reinzonen: solche mit unidirektionalem Luftstrom und solche mit nicht unidirektionalem Luftstrom, die in drei möglichen Belegungszuständen getestet werden: im Neuzustand (as-built), im Ruhezustand (at-rest) und im Betriebszustand (operational). Ein wesentliches Merkmal der Norm ist die Bereitstellung von spezifischen Leistungstests sowie von empfohlenen Prüfgeräten und Prüfverfahren zur Bestimmung von Leistungsparametern. Die Norm berücksichtigt unterschiedliche Typen von Reinräumen und schlägt alternative Verfahren vor, falls die Prüfmethoden durch den Typ des Reinraums oder der Reinzone beeinflusst werden. Dies zeigt die Flexibilität der Norm und ihren Ansatz, verschiedene Einsatzbedingungen zu berücksichtigen. Ein weiterer starker Punkt von SIST EN ISO 14644-3:2020 ist die Empfehlung mehrerer unterschiedlicher Methoden und Apparate für einige Tests, die es ermöglichen, auf unterschiedliche Endnutzungsanforderungen einzugehen. Dies fördert nicht nur die Anwendung der Norm in einer Vielzahl von industriellen Sektoren, sondern unterstützt auch den Dialog zwischen Kunde und Lieferant bei der Vereinbarung alternativer Methoden, die möglicherweise nicht in diesem Dokument enthalten sind. Die Norm ist jedoch nicht auf die Messung von Produkten oder Prozessen in Reinräumen, Reinzonen oder separierenden Geräten anwendbar, was es wichtig macht, den spezifischen Anwendungsbereich zu verstehen. Außerdem ist es zu beachten, dass die Norm keine Sicherheitsüberlegungen behandelt, die im Zusammenhang mit dem Gebrauch (z. B. bei der Verwendung gefährlicher Materialien, Operationen und Ausrüstungen) stehen. Dies erfordert von den Nutzern, angemessene Sicherheits- und Gesundheitspraktiken zu etablieren und die Anwendbarkeit regulatorischer Einschränkungen vor der Anwendung zu prüfen. Insgesamt ist die SIST EN ISO 14644-3:2020 von großer Relevanz für alle, die mit dem Betrieb von Reinräumen und kontrollierten Umgebungen betraut sind. Ihre präzisen Testmethoden und flexiblen Ansätze zur Leistungsbewertung bieten eine solide Grundlage für die Gewährleistung von Reinheit und Sicherheit in kritischen Umgebungen.
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