EN ISO 14644-3:2019

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

• Status: Published
• Publication Date: 15-Oct-2019
• Withdrawal Date: 29-Apr-2020
• ICS: 13.040.35 - Cleanrooms and associated controlled environments
• Technical Committee: CEN/TC 243 - Cleanroom technology
• Drafting Committee: CEN/TC 243 - Cleanroom technology
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 16-Oct-2019
• Completion Date: 16-Oct-2019
• Ref Project: SIST EN ISO 14644-3:2020 - Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2019, Corrected version 2020-06)

Relations

• Replaces: EN ISO 14644-3:2005 - Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005)
• Effective Date: 23-Oct-2019

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: [phone]
Fax: [phone]
Email: [e-mail]
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 .ht
...

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: [phone]
Fax: [phone]
Email: [e-mail]
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 pa
...