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.
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
Buy Standard
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 14644-3:2020
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
SIST EN ISO 14644-3:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 14644-3:2020
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SIST EN ISO 14644-3:2020
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.
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SIST EN ISO 14644-3:2020
EN ISO 14644-3:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 14644-3:2020
EN ISO 14644-3:2019 (E)
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.
3
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SIST EN ISO 14644-3:2020
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
ISO 14644-3:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 14644-3:2020
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 2019 – All rights reserved iii
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SIST EN ISO 14644-3:2020
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.
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SIST EN ISO 14644-3:2020
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).
© ISO 2019 – All rights reserved v
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SIST EN ISO 14644-3:2020
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SIST EN ISO 14644-3:2020
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.
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
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)
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
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 2019 – All rights reserved 5
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SIST EN ISO 14644-3:2020
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 eval
...
SLOVENSKI STANDARD
SIST EN ISO 14644-3:2020
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
SIST EN ISO 14644-3:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 14644-3:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 14644-3:2020
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 14644-3:2020
EN ISO 14644-3:2019 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 14644-3:2020
EN ISO 14644-3:2019 (E)
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.
3
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SIST EN ISO 14644-3:2020
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SIST EN ISO 14644-3:2020
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
---------------------- Page: 7 ----------------------
SIST EN ISO 14644-3:2020
ISO 14644-3:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST EN ISO 14644-3:2020
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 2019 – All rights reserved iii
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
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).
© ISO 2019 – All rights reserved v
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SIST EN ISO 14644-3:2020
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SIST EN ISO 14644-3:2020
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 2019 – All rights reserved 1
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
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 2019 – All rights reserved 3
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SIST EN ISO 14644-3:2020
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
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SIST EN ISO 14644-3:2020
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 2019 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 14644-3:2020
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
...
SLOVENSKI STANDARD
oSIST prEN ISO 14644-3:2016
01-december-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO 3UHVNXVQHPHWRGH ,62',6
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO/DIS
14644-3:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 3: Prüfverfahren (ISO/DIS 14644-
3:2016)
Salles propres et environnements maîtrisés apparentés - Partie 3: Méthodes d'essai
(ISO/DIS 14644-3:2016)
Ta slovenski standard je istoveten z: prEN ISO 14644-3
ICS:
13.040.35 Brezprašni prostori in Cleanrooms and associated
povezana nadzorovana controlled environments
okolja
oSIST prEN ISO 14644-3:2016 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 14644-3:2016
---------------------- Page: 2 ----------------------
oSIST prEN ISO 14644-3:2016
DRAFT INTERNATIONAL STANDARD
ISO/DIS 14644-3
ISO/TC 209 Secretariat: ANSI
Voting begins on: Voting terminates on:
2016-12-16 2017-03-09
Cleanrooms and associated controlled environments —
Part 3:
Test methods
Salles propres et environnements maîtrisés apparentés —
Partie 3: Méthodes d’essai
ICS: 13.040.35
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 14644-3:2016(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2016
---------------------- Page: 3 ----------------------
oSIST prEN ISO 14644-3:2016
ISO/DIS 14644-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 14644-3:2016
ISO/DIS 14644-3:2016(E)
Contents
Foreword. 5
Introduction . 7
1 Scope . 8
2 Normative references. 8
3 Terms and definitions . 9
4 Test procedures .16
5 Test reports.19
Annex A (informative) Choice of supporting tests and checklist .13
A.1 General .13
A.2 Test checklist.13
A.3 Pre-test conditions .17
A.4 Guidance on typical time intervals for periodic testing .17
Annex B (informative) Supporting test methods .19
B.1 Air pressure difference test.19
B.2 Airflow test .21
B.3 Airflow direction test and visualization .26
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B.4 Recovery test .29
B.5 Temperature test.32
B.6 Humidity test.34
B.7 Installed filter system leakage test .35
B.8 Containment leak test .49
B.9 Electrostatic and ion generator tests .50
B.10 Particle deposition test .53
B.11 Segregation test .56
Annex C (informative) Test apparatus .59
C.1 Air pressure difference test .59
C.2 Airflow test .60
C.3 Airflow direction test and visualization.61
C.4 Recovery test .62
C.5 Temperature test .63
C.6 Humidity test .63
C.7 Installed filter system leakage test.64
C.8 Containment leak test.64
C.9 Electrostatic and ion generator test.65
C.10 Particle deposition test .66
C .11 Entrainment test .67
Bibliography .69
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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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO's adherence to the WTO principles in the Technical Barriers to Trade
(TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 209.
ISO 14644-3 was prepared by Technical Committee ISO/TC 209, Cleanrooms and associated controlled
environments.
ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled
environments:
Part 1: Classification of air cleanliness by particle concentration
Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle
concentration
Part 3: Test methods
Part 4: Design, construction and start-up
Part 5: Operations
Part 6: Vocabulary
Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 8: Classification of air cleanliness by chemical concentration (ACC)
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Part 9: Classification of surface cleanliness by particle concentration
Part 10: Classification of air cleanliness by chemical concentration
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Introduction
Cleanrooms and associated controlled environments provide for the control of airborne 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 part of ISO 14644 sets out appropriate test methods for measuring the performance of an installation,
a cleanroom or an associated controlled environment.
NOTE Not all cleanroom parameter test procedures are shown in this part of ISO 14644. The procedure
and apparatus for the test carried out for the air cleanliness classes by particle concentration are provided
in ISO 14644-1, and specifications for monitoring air cleanliness by nanoscale particle concentrations are
provided in ISO 14644-12(20XX). 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
materials (ISO 14698), testing cleanroom functionality (ISO 14644-4), and testing of separative devices
(ISO 14644-7)]. In addition, other standards can be considered to be applicable.
Statements in this part of ISO 14644 reference the standards of ASTM, CEN, DIN, IEST, JACA, JIS and SEMI.
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Cleanrooms and associated controlled environments — Part 3: Test
methods
1 Scope
This part of ISO 14644 provides test methods in support of the operation for cleanrooms and clean
zones to meet air cleanliness classifications and related controlled conditions. Tests for classification of
cleanliness are described in ISO 14644-1(classification of air cleanliness by particle concentration and
for macroparticles). Other related attribute levels can be determined using ISO 14644-8 (levels of air
cleanliness by chemicals), ISO 14644-9 (levels of surface cleanliness by particle concentration) and ISO
14644-10 (levels of surface cleanliness by chemical concentration). Performance tests are specified for
two types of cleanrooms and clean zones: those with unidirectional flow and those with non -
unidirectional flow, in three possible occupancy states: as-built, at-rest and operational. The test
methods, recommend 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 part of ISO 14644 may be used if based on agreement between customer and supplier. Alternative
methods do not necessarily provide equivalent measurements.
This part of ISO 14644 is not applicable to the measurement of products or of processes in cleanrooms,
clean zones or separative devices.
NOTE: This part of ISO 14644 does not purport to address safety problems associated with its use (for
example, when using hazardous materials, operations and equipment). It is the responsibility of the
user of this part of ISO 14644 to establish appropriate safety and health practices and to determine the
applicability of regulatory limitations prior to use.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 7726:1998, Ergonomics of the thermal environment — Instruments for measuring physical quantities
ISO 14644-1:2015, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness by particle concentration
ISO 14644-2:2015, Cleanrooms and associated controlled environments — Part 2: Monitoring to provide
evidence of cleanroom performance related to air cleanliness by particle concentration
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ISO 14644-4:2001, Cleanrooms and associated controlled environments — Part 4: Design, construction and
start-up
ISO 14644-7:2004, Cleanrooms and associate controlled environments — Part 7: Separative devices (clean
air hoods, gloveboxes, isolators and minienvironments).
ISO 14644-8:2013, Cleanrooms and associate controlled environments — Part 8: Classification of air
cleanliness by chemical concentration (ACC).
ISO 14644-9:2012, Cleanrooms and associate controlled environments — Part 9: Classification of surface
cleanliness by particle concentration.
ISO 14644-10:2013, Cleanrooms and associated controlled environments — Part 10: Classification of surface
cleanliness by chemical concentration.
3 Terms and definitions
3.1 General
3.1.1 cleanroom
room within which the number concentration of airborne particles is controlled and classified, and
which is designed, constructed and operated in a manner to control the introduction, generation and
retention of particles inside the room
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
humidity, pressure, vibration and electrostatic.
[ISO 14644-1:2015, 3.1.1]
3.1.2
clean zone
defined space within which the number concentration of airborne particles is controlled and classified,
and which is constructed and operated in a manner to control the introduction, generation and retention
of contaminants inside the space
Note 1 to entry: The class of airborne particle concentration is specified.
Note 2 to entry: Levels of other cleanliness attributes such as chemical, viable or nanoscale concentrations in the
air, and also surface cleanliness in terms of particle, nanoscale, chemical and viable concentrations might also be
specified and controlled.
Note 3 to entry: A clean zone(s) can be a defined space within a cleanroom or might be achieved by a separative
device. Such a device can be located inside or outside a cleanroom.
Note 4 to entry: Other relevant physical parameters might also be controlled as required, e.g. temperature,
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humidity, pressure, vibration and electrostatic.
[ISO 14644-1:2015, 3.1.2]
3.1.3
installation
cleanroom or one or more clean zones, together with all associated structures, air-treatment systems,
services and utilities
[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.
3.1.5
resolution
smallest change in a quantity being measured that causes a perceptible change in the correspondin g
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.
3.1.6
maximum permissible measurement error
extreme value of measurement error, with respect to a known reference quantity value, permitted by
specifications or regulations for a given measurement, measuring apparatus, or measuring system
Note 1 to entry: Usually the term maximum permissible errors or limit error is used when there are two extreme
values.
3.1.7
sensitivity
quotient of the change in an indication of a measuring system and the corresponding change in a value of a
quality of the quantity being measured
3.2 Airborne particulates
3.2.1
airborne particle
solid or liquid object suspended in air, viable or non-viable, sized (for the purpose of this part of ISO
14644) between 1 nm and 100 µm
Note 1 to entry: For classification purposes, refer to ISO 14644-1:2015, 3.2.1.
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3.2.2
count median particle diameter
CMD
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
MMD
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
[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 discrete-particle light-scattering instruments, the equivalent optical diameter is used.
[ISO 14644-1:2015, 3.2.2]
3.2.6
particle size distribution
cumulative distribution of particle concentration as a function of particle size
[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 Air filters and systems
3.3.1
aerosol challenge
challenging of a filter or an installed filter system by test aerosol
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3.3.2
designated leak
maximum allowable penetration, which is determined by agreement between customer and supplier,
through a leak, detectable during scanning of an installation with discrete-particle counters or aerosol
photometers
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
system composed of filter, frame and other support system or other housing
3.3.5
final filter
filters in a final position before the air enters the cleanroom or clean zone
3.3.6
installed filter system
filter system 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 in the installation, and that the filters and the grid system are free of d efects and leaks
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 in filters and parts of units, whereby the probe inlet of an aerosol photometer
or discrete-particle counter is moved in overlapping strokes across the defined test area
3.3.10
standard leak penetration
leak penetration detected by a discrete-particle counter or aerosol photometer with a standard sample
flow- rate when the sampling probe is stationary in front of the leak
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Note 1 to entry: Penetration is the ratio of the particle concentration downstream of the filter to the concentration
upstream.
3.4 Airflow and other physical states
3.4.1
air exchange rate
rate of air exchange expressed as 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 or clean zone
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 or clean zone mixes with the internal air by
means of induction
[ISO 14644-4:2001, 3.6]
3.4.4
supply air volume flow rate
air volume supplied into an installation from final filters or air ducts in unit of time
3.4.5
total air volume flow rate
air volume that passes through a section of an installation in unit of time
3.4.6
unidirectional airflow
controlled airflow through the entire cross-section of cleanroom or clean zone with a steady velocity and
approximately parallel streamlines
Note 1 to entry: This type of airflow results in a directed transport of particles from the cleanroom or clean zone.
[ISO 14644-4:2001, 3.11]
3.4.7
uniformity of airflow
unidirectional airflow pattern in which the point-to-point readings of velocities are within a defined
percentage of the average airflow velocity
3.5 Electrostatic measurement
3.5.1
discharge time
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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 will accumulate upon 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 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 may be produced by thermal, hydraulic, pneumatic, acoustic or
electrostatic means
3.6.2
aerosol photometer
light-scattering airborne particle mass concentration measuring apparatus, which uses a forward -
scattered- light optical chamber to make measurements
3.6.3
anisokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inl et is significantly
different from the mean velocity of the unidirectional airflow at that location
3.6.4
counting efficiency
ratio of the reported concentration of particles in a given size range to the actual concentration of such
particles
3.6.5
discrete-particle counter
DPC
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apparatus having a means of displaying and recording the count and size of discrete particles (with a size
discrimination) for specific air volume
3.6.6
false count
background noise count
zero count
count produced by a discrete-particle counter (DPC) due to internal or external unwanted electronic signal
when no particles exist
3.6.7
airflow capture hood with measuring device
device with apparatus to directly measure the air volume flow rate at each final filter or air diffuser in an
installation, set up to completely cover the filter or diffuser
3.6.8
iso-axial sampling
sampling condition in which the direction of the airflow into the sample probe inlet is the same as that of
the unidirectional airflow being sampled
3.6.9
isokinetic sampling
sampling condition in which the mean velocity of the air entering the sample probe inlet is the same as the
mean velocity of the unidirectional airflow at that location
3.6.10
particle size cutoff device
device capable of removing particles smaller than those of interest that is attached to the inlet of a DPC or
CPC
3.6.11
threshold size
selec
...
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