The qualification of cleanrooms and clean air systems includes the entire compliance evaluation process of all relevant standards required for the intended use of typical equipment. A decisive step of this qualification process is covered by the application of EN ISO 14644 and its harmonization with Annex 1 in the EU GMP guidelines, among others, the corresponding particulate limit values. Appropriate recommendations for the qualification and requalification of cleanrooms and clean air systems can be derived from these minimum requirements.

In rooms used for medical purposes, the requirements for ventilation systems and their components have been revised in accordance with the current ÖNORM H 6020. The main changes concern, among others, the classification of room classes according to air quality requirements, the differentiation of operating rooms according to their air flow (unidirectional / non-unidirectional) and scope and frequency of inspections.

In order to emphasize the different classes of biological safety cabinets, EN 12469 has been revised and is currently under review. The relevant parts of prEN 12469 define the minimum requirements for installation, commissioning and routine testing of biological safety cabinets (inter alia, with regard to personal protection).