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ONORM EN ISO 14644-18:2024
Cleanrooms and associated controlled environments - Part 18: Assessment of suitability of consumables (ISO 14644-18:2023)
This document provides guidance for the evaluation of personal and non-personal consumable items for their appropriate use in clean rooms, clean areas or controlled areas based on product and process requirements, cleanliness attributes and functional performance characteristics. The purity attributes covered are particles or chemicals in the air or on surfaces. Biocontamination (viable particles/microorganisms or pyrogens) is considered a special property of consumer items. The identification of associated risks is taken into account. This document supplements the cleanroom operation described in ISO 14644 5. This document provides guidance for: - determining the cleanroom suitability of consumables in general; - the specification of requirements for the intended use of a consumer item by the customer with regard to the functional performance properties, purity attributes and special properties; - the specification of properties for an intended use of a consumer item by the supplier; - the evaluation of a consumable item for appropriate use; - the documentation. Informational appendices are used to provide examples of personal and non-personal consumables, verification procedures for cleanliness attributes, and the potential impact of consumables on a cleanroom. Cleaning agents, disinfectants and lubricants are considered consumable items in terms of their packaging, as their packaging is likely to have the same cleanliness requirements as all consumable items. This document is not applicable to: - design details of consumable items; - testing the functional performance properties of materials, e.g. B. Barrier properties of gloves, wear and slip resistance of flooring; - Health and safety requirements; legal requirements may apply in certain countries; - cleaning ability; - (Raw) materials that are added as ingredients within the production process; - performance or functional tests; - transport containers; - Process media such as gases or liquids; - the functional performance properties of cleaning agents, disinfectants and lubricants.
Austrian Standards Institute [on]