EN ISO 14644-14:2016

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1).
NOTE          Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required.
The following items are not covered by this ISO 14644-14:2016:
-      assessment of suitability with respect to biocontamination;
-      testing for suitability of decontamination agents and techniques;
-      cleanability of equipment and materials;
-      requirements on design of equipment and selection of materials;
-      physical properties of materials (e.g. electrostatic, thermal properties);
-      optimizing performance of equipment for specific process applications;
-      selection and use of statistical methods for testing;
-      protocols and requirements for local safety regulations.

Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft (ISO 14644-14:2016)

Dieser Teil von ISO 14644 legt eine Methodik zur Bewertung der Reinraumtauglichkeit von Geräten (z. B. Maschinen, Messgeräte, Prozessausrüstung, Komponenten und Werkzeuge) für die Anwendung in Reinräumen und zugehörigen kontrollierten Bereichen in Bezug auf die luftgetragene Partikelreinheit nach den Festlegungen in ISO 14644 1 fest. Der Partikelgrößenbereich reicht von 0,1 µm bis gleich oder größer als 5 µm (in ISO 14644 1 angegeben).
ANMERKUNG   Sofern die zuständigen Behörden ergänzende Richtlinien oder Einschränkungen vorgeben, können geeignete Anpassungen der Methodik zur Bewertung erforderlich sein.
Die folgenden Aspekte sind nicht durch diesen Teil von ISO 14644 abgedeckt:
   Bewertung der Tauglichkeit in Bezug auf die Biokontamination;
   Prüfung zur Tauglichkeit von Dekontaminationsmitteln und -techniken;
   Reinigungsfähigkeit der Geräte und Materialien;
   Anforderungen an die konstruktive Auslegung von Geräten und die Auswahl von Materialien;
   physikalische Materialeigenschaften (z. B. elektrostatische, thermische Eigenschaften);
   Optimierung der Geräteleistung für spezifische Prozessanwendungen;
   Auswahl und Anwendung statistischer Verfahren für die Prüfung;
   Protokolle und Anforderungen hinsichtlich regionaler Sicherheitsvorschriften.

Salles propres et environnements maîtrisés apparentés - Partie 14: Évaluation de l'aptitude à l'emploi des équipements par la détermination de la concentration de particules en suspension dans l'air (ISO 14644-14:2016)

ISO 14644-14:2016 définit une méthodologie pour évaluer l'aptitude de l'équipement (par exemple, machines, équipements de mesure, équipements de procédé, composants, outils) à être employé dans les salles propres et les environnements maîtrisés apparentés, pour ce qui concerne la propreté particulaire de l'air telle que spécifiée dans l'ISO 14644‑1. La taille des particules varie de 0,1 µm à 5 µm ou plus (indiquée dans l'ISO 14644‑1).
NOTE          Lorsque les instances réglementaires imposent des lignes directrices ou des restrictions supplémentaires, il peut s'avérer nécessaire d'adapter la méthodologie d'évaluation en conséquence.
Les éléments suivants ne sont pas traités dans l'ISO 14644-14:2016:
-      l'évaluation de l'aptitude à l'emploi par rapport à la biocontamination;
-      les essais d'aptitude à l'emploi des agents et des techniques de décontamination;
-      la nettoyabilité des équipements et matériaux;
-      les exigences relatives à la conception de l'équipement et à la sélection des matériaux;
-      les propriétés physiques des matériaux (par exemple, propriétés électrostatiques, thermiques);
-      l'optimisation des performances de l'équipement pour des applications de procédé particulières;
-      la sélection et l'utilisation de méthodes statistiques pour les essais;
-      les protocoles et exigences relatifs à la réglementation locale sur la sécurité.

Čisti prostori in z njimi povezana nadzorovana okolja - 14. del: Ocenjevanje primernosti uporabe opreme na podlagi koncentracije lebdečih delcev (ISO 14644-14:2016)

Ta del standarda ISO 14644 določa metodologijo za ocenjevanje primernosti opreme (npr. strojev, merilne opreme, procesne opreme, komponent in orodij) za uporabo v čistih sobah in podobnih nadzorovanih okoljih glede na čistost zraka na osnovi koncentracije lebdečih delcev, kot je določena v standardu ISO 14644-1.
Velikost delcev je v razponu od 0,1 μm do 5 μm ali več (razpon je podan v standardu ISO 14644-1).
OPOMBA: Če zakonodajni organi predpisujejo dodatne smernice ali omejitve, je metodologijo ocenjevanja morda treba ustrezno prilagoditi.
Naslednji elementi niso vključeni v ta del standarda ISO 14644:
– ocenjevanje primernosti glede na možnost biokontaminacije;
– preskušanje primernosti sredstev in tehnik za dekontaminacijo;
– možnost čiščenja opreme in materialov;
– zahteve za zasnovo opreme in izbiro materialov;
– fizične lastnosti materialov (npr. elektrostatične in toplotne lastnosti);
– optimizacija delovanja opreme za uporabo pri določenem postopku;
– izbira in uporaba statističnih metod za preskušanje;
– protokoli in zahteve za lokalne varnostne predpise.

General Information

• Status: Published
• Publication Date: 04-Oct-2016
• Withdrawal Date: 29-Apr-2017
• 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: 05-Oct-2016
• Completion Date: 05-Oct-2016
• Ref Project: SIST EN ISO 14644-14:2016 - Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2016)

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2016
ýLVWHVREHLQSRGREQDQDG]RURYDQDRNROMDGHO2FHQMHYDQMHSULPHUQRVWL
XSRUDEHRSUHPHQDRVQRYLNRQFHQWUDFLMHOHEGHþLKGHOFHY,62
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft ((ISO 14644-
14:2016)
Salles propres et environnements maîtrisés apparentés - Partie 14: Evaluation de la
compatibilité des équipments en termes d'émission particulaire pour une utilisation en
salle propre (ISO 14644-14:2016)
Ta slovenski standard je istoveten z: EN ISO 14644-14:2016
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 14644-14
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
14: Assessment of suitability for use of equipment by
airborne particle concentration (ISO 14644-14:2016)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 14: Évaluation de l'aptitude à l'emploi des 14: Bewertung der Reinraumtauglichkeit von Geräten
équipements par la détermination de la concentration durch Partikelkonzentration in der Luft (ISO 14644-
de particules en suspension dans l'air (ISO 14644- 14:2016)
14:2016)
This European Standard was approved by CEN on 13 August 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-14:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-14:2016) 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 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-14
First edition
2016-09-15
Cleanrooms and associated controlled
environments —
Part 14:
Assessment of suitability for use
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l’aptitude à l’emploi des équipements par
la détermination de la concentration de particules en suspension
dans l’air
Reference number
ISO 14644-14:2016(E)
©
ISO 2016
ISO 14644-14:2016(E)
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 14644-14:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General outline of the assessment . 3
5 Visual inspection . 3
6 Assessment of suitability by airborne particle concentration measurements .4
6.1 General . 4
6.2 Assessment procedure . 4
6.2.1 Overview . 4
6.2.2 Requirements and considerations . 5
6.2.3 Representative mode of operation . 6
6.2.4 Considerations for the test environment . 6
6.2.5 Determination of the test environment . 6
6.2.6 Approximate identification of HPC location(s) . 6
6.2.7 Precise determination of HPC location(s) . 7
6.2.8 Suitability measurement(s) . 7
6.2.9 Data processing . 8
6.2.10 Reference to ISO 14644‑1 classification system .10
7 Documentation .10
7.1 General .10
7.2 Common documentation requirements .10
7.3 Documentation for visual inspection .11
7.4 Documentation for assessment of test environment .11
7.5 Documentation for classification measurement .12
8 Statement on cleanroom suitability .12
Annex A (informative) Example for data processing deriving from measurements .14
Annex B (informative) Additional optional tests .18
Bibliography .21
ISO 14644-14:2016(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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all part in the ISO 14644 series, published under the general title Cleanrooms and associated
controlled environments, can be found on the ISO website.
iv © ISO 2016 – All rights reserved

ISO 14644-14:2016(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination‑sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).
This part of ISO
...

SLOVENSKI STANDARD
01-december-2016
Čisti prostori in z njimi povezana nadzorovana okolja - 14. del: Ocenjevanje
primernosti uporabe opreme na podlagi koncentracije lebdečih delcev (ISO 14644-
14:2016)
Cleanrooms and associated controlled environments - Part 14: Assessment of suitability
for use of equipment by airborne particle concentration (ISO 14644-14:2016)
Reinräume und zugehörige Reinraumbereiche - Teil 14: Bewertung der
Reinraumtauglichkeit von Geräten durch Partikelkonzentration in der Luft ((ISO 14644-
14:2016)
Salles propres et environnements maîtrisés apparentés - Partie 14: Evaluation de la
compatibilité des équipments en termes d'émission particulaire pour une utilisation en
salle propre (ISO 14644-14:2016)
Ta slovenski standard je istoveten z: EN ISO 14644-14:2016
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 14644-14
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2016
EUROPÄISCHE NORM
ICS 13.040.35
English Version
Cleanrooms and associated controlled environments - Part
14: Assessment of suitability for use of equipment by
airborne particle concentration (ISO 14644-14:2016)
Salles propres et environnements maîtrisés apparentés Reinräume und zugehörige Reinraumbereiche - Teil
- Partie 14: Évaluation de l'aptitude à l'emploi des 14: Bewertung der Reinraumtauglichkeit von Geräten
équipements par la détermination de la concentration durch Partikelkonzentration in der Luft (ISO 14644-
de particules en suspension dans l'air (ISO 14644- 14:2016)
14:2016)
This European Standard was approved by CEN on 13 August 2016.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14644-14:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 14644-14:2016) 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 2017, and conflicting national standards shall be
withdrawn at the latest by April 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 14644-14:2016 has been approved by CEN as EN ISO 14644-14:2016 without any
modification.
INTERNATIONAL ISO
STANDARD 14644-14
First edition
2016-09-15
Cleanrooms and associated controlled
environments —
Part 14:
Assessment of suitability for use
of equipment by airborne particle
concentration
Salles propres et environnements maîtrisés apparentés —
Partie 14: Évaluation de l’aptitude à l’emploi des équipements par
la détermination de la concentration de particules en suspension
dans l’air
Reference number
ISO 14644-14:2016(E)
©
ISO 2016
ISO 14644-14:2016(E)
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 14644-14:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General outline of the assessment . 3
5 Visual inspection . 3
6 Assessment of suitability by airborne particle concentration measurements .4
6.1 General . 4
6.2 Assessment procedure . 4
6.2.1 Overview . 4
6.2.2 Requirements and considerations . 5
6.2.3 Representative mode of operation . 6
6.2.4 Considerations for the test environment . 6
6.2.5 Determination of the test environment . 6
6.2.6 Approximate identification of HPC location(s) . 6
6.2.7 Precise determination of HPC location(s) . 7
6.2.8 Suitability measurement(s) . 7
6.2.9 Data processing . 8
6.2.10 Reference to ISO 14644‑1 classification system .10
7 Documentation .10
7.1 General .10
7.2 Common documentation requirements .10
7.3 Documentation for visual inspection .11
7.4 Documentation for assessment of test environment .11
7.5 Documentation for classification measurement .12
8 Statement on cleanroom suitability .12
Annex A (informative) Example for data processing deriving from measurements .14
Annex B (informative) Additional optional tests .18
Bibliography .21
ISO 14644-14:2016(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 on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 209, Cleanrooms and associated controlled
environments.
A list of all part in the ISO 14644 series, published under the general title Cleanrooms and associated
controlled environments, can be found on the ISO website.
iv © ISO 2016 – All rights reserved

ISO 14644-14:2016(E)
Introduction
Cleanrooms and associated controlled environments provide for the control of contamination to levels
appropriate for accomplishing contamination‑sensitive activities. Products and processes that benefit
from the control of contamination include those in such industries as aerospace, microelectronics,
optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).
This part of ISO 146
...