The qualification of cleanrooms and clean air systems includes the entire assessment process for compliance with the relevant normative requirements for the intended use of typical trades. A decisive component of this qualification process is covered by the application of EN ISO 14644 and its harmonisation - including the corresponding particulate limit values - with Annex 1 in the EU GMP guidelines. Corresponding recommendations for the qualification and requalification of cleanrooms and clean air systems can be derived from these minimum requirements.

EN 12469 has been revised to emphasise the different classes of biological safety cabinets (BSW). The minimum requirements for the installation, commissioning and routine testing of biological safety cabinets are defined in the relevant sections. The workbenches are categorised into different classes based on their level of protection and application. In addition to structural and ergonomic requirements, detailed test methods for assessing performance are specified.