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
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
05-Oct-2016
Completion Date
05-Oct-2016

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14644-14:2016
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
SIST EN ISO 14644-14:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 14644-14:2016

---------------------- Page: 2 ----------------------

SIST EN ISO 14644-14:2016


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.

---------------------- Page: 3 ----------------------

SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
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, Slova
...

SLOVENSKI STANDARD
SIST EN ISO 14644-14:2016
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
SIST EN ISO 14644-14:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 14644-14:2016

---------------------- Page: 2 ----------------------
SIST EN ISO 14644-14:2016


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.

---------------------- Page: 3 ----------------------
SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
Contents Page
European foreword . 3

2

---------------------- Page: 4 ----------------------
SIST EN ISO 14644-14:2016
EN ISO 14644-14:2016 (E)
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, Roman
...

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