The determination of the water-soluble total organic carbon (TOC) is an essential part of tests in the context of validation or monitoring of the final cleaning of medical devices, in the validation of the reprocessing instructions for medical devices and the determination of the maximum number of possible reprocessings.
In conjunction with cytotoxicity tests, bioburden determinations, endotoxin tests and particulate tests, TOC determination is an essential component in determining the surface cleanliness of medical devices, especially after final cleaning.
The TOC allows the quantification of water-soluble organic carbons according to ISO 19227:2018 and represents a sum parameter for water-soluble organic residues such as process auxiliaries (especially cleaning agents) and for the water-soluble portion of polymers. DIN EN ISO 10993-18 is also applicable.
The result is stated in the test report as a sum parameter of the water-soluble organic carbons in µg/test object or, in the case of water samples, also in µg/ml.
|Extraction||Extraction of the product|
|Measurement||Measurement of the TOC of the extract|
|Analysis||Calculation of the TOC per test object|
|Unit||µg/test object or for water samples µg/ml|