Standard Test Method for Extracting Residue from Medical Components and Quantifying via Gravimetric Analysis

Importancia y uso:

5.1 This test method is suitable for determination of the total amount of extractable residue on metallic, polymeric, and ceramic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as insoluble residue.

5.2 This test method recommends the use of either a sonication technique or a solvent reflux technique (Soxhlet) to extract residue from the medical component. Other techniques such as shaker/tip tables could be used but have been shown to be less efficient in some tests, as discussed in X1.2.

5.3 This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).

Subcomité:

F04.15

Referida por:

F2847-17, F3127-22, F3321-19, F3335-20

Volúmen:

13.01

Número ICS:

11.100.99 (Other standards related to laboratory medicine)

Palabras clave:

additive manufacturing; ceramic medical components; cleaning; cleanliness; extractable residue; gravimetric analysis; insoluble debris; metallic medical components; non-water soluble extractable residue; polymeric medical components; water soluble extractable residue;