Validation of product cleaning/cleanliness

A reproducible product cleanliness is an important prerequisite especially for biocompatibility and safe application of medical devices. This is not only valid for medical devices delivered sterile. Significant aspects of cleanliness (e.g. chemical production remnants) must also be taken into account in the case of instruments and other medical devices delivered non-sterile and intended for processing before use. For this and dependent on risk assessment and intended use, according to DIN TS 5343 (and ISO 19227) bioburden determination, endotoxin and particle test as well as cytotoxicity test and chemical analysis (organic, inorganic) are required.

These tests already will be performed according to the current requirements of DIN TS 5343: 2022 (and ISO 19227: 2018) as well as of the new editions of ISO 10993-18 (including selection of the test procedures for cytotoxicity test and chemical analysis already for subsequent use also for biocompatibility assessment).