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EN ISO 14644-14:2026

Cleanrooms and associated controlled environments - Part 14: Assessment of suitability for use of equipment by airborne particle concentration (ISO 14644-14:2026)

Edition date: 2026-03-11
In Force
Available languages: English, French
Summary: This document 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. This document is not applicable to the following items: 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.

Le présent document 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. Le présent document ne s’applique pas aux éléments suivants: 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.

Dieses Dokument 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. Dieses Dokument ist nicht für Folgendes anwendbar:  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.
ICS: 13.040.35-Cleanrooms and associated controlled environments
CTN: CEN/TC 243 - 6224

Otras Relaciones

Acuerdo de Viena ISO 14644-14:2026

Reemplazo Normas

Reemplaza a EN ISO 14644-14:2016

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