This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom. NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments). The following subjects are mentioned but not addressed in this document: — specific operational activities, processes to be accommodated and process equipment in the cleanroom installation; — fire and safety regulations; — ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.
This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the requirements, design, construction and start-up, which include important performance parameters to be considered. Energy management design approaches are identified to support an energy-efficient cleanroom design. Construction guidance is provided, including requirements for start-up and verification. A basic element of this document is consideration of aspects, including maintenance, that will help to ensure continued satisfactory operation for the entire life cycle of the cleanroom.
NOTE Further guidance is given in Annexes A to D. ISO 14644-1, ISO 14644-2, ISO 14644-8, ISO 14644-9, ISO 14644-10, ISO 14644-12 and ISO 14644-17 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for separative devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this document:
— specific operational activities, processes to be accommodated and process equipment in the cleanroom installation;
— fire and safety regulations;
— ongoing operation, cleaning and maintenance activities, which are covered by ISO 14644-5.
<p> La présente partie de l'ISO 14644 spécifie les exigences pour la conception et la construction d'installations de salles propres, mais elle ne prescrit nullement les moyens spécifiques technologiques ni contractuels permettant de satisfaire à ces exigences. Elle s'adresse aux acheteurs, fournisseurs et concepteurs des installations de salles propres et comprend une liste indicative de paramètres importants de performance. Des conseils en matière de construction sont proposés, accompagnés des exigences de mise en fonctionnement et de qualification. Les éléments de base de la conception et de la construction, nécessaires pour assurer le maintien d'un fonctionnement satisfaisant, sont identifiés par l'examen des aspects pertinents de l'exploitation et de la maintenance. <br/> <br/>NOTE Des conseils complémentaires concernant les exigences ci-dessus sont fournis dans les annexes A à H. D'autres parties de l'ISO 14644 sont susceptibles de fournir des renseignements complémentaires. L'application de la présente partie de l'ISO 14644 est sujette aux limitations suivantes : - les exigences de l'utilisateur sont représentées par l'acheteur ou le prescripteur ; - des procédés spécifiques qu'hébergera l'installation de salle propre ne sont pas spécifiés ; - les règlements de sécurité et de protection incendie ne font pas l'objet d'un examen particulier; il convient de se conformer aux règlements nationaux ou locaux applicables; - on ne tient compte des fluides pour le procédé et des servitudes de raccordement et alimentations des systèmes que pour ce qui concerne le cheminement des réseaux entre, et à l'intérieur, des différentes zones de propreté ; - en ce qui concerne la mise en service et la maintenance, il n'est tenu compte que des exigences spécifiques aux salles propres. </p>
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