NF EN ISO 14644-18, X44-101-18 (10/2023)

This document provides recommendations for the evaluation of personnel and other consumables for their appropriate use in clean rooms, clean zones or controlled areas, based on product and process requirements, cleanliness attributes and properties. functional performance. The cleanliness attributes covered are particles or chemicals in the air or on surfaces. Biocontamination (viable particles, microorganisms or pyrogens) is considered a particular property of consumables. Identification of associated risks is considered. This document complements the operation of clean rooms as described in ISO 14644-5. This document provides recommendations regarding: — determining the suitability for cleanroom use of consumables in general; — specification of requirements for intended use of a consumable by the customer in terms of functional performance, cleanliness attributes and particular properties; — the specification of the properties for the intended use of a consumable by the supplier; — the evaluation of a consumable for appropriate use; - the documentation. Informative appendices are used to list examples of personnel and other consumables, verification methods for testing cleanliness attributes, and the potential impact of consumables on a cleanroom. Cleaning agents, disinfectants and lubricants are considered consumables with respect to their packaging, as their packaging is likely to have common property requirements with all consumables. This document does not apply to the following: — consumable design details; — functional performance testing of materials, e.g. barrier properties of gloves, wear and slip resistance of floor coverings; — health and safety requirements; legal requirements may apply in certain countries; — cleanability; — (raw) materials added as ingredients in the production process; — performance or functional tests; — transport containers; — process utilities such as gases or liquids; — functional performance of cleaning agents, disinfectants and lubricants.
(Automatic translation from French)