Standard Guide for Methods of Extraction of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

Importancia y uso:

5.1 This guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.

5.2 This guide helps medical device manufacturers to identify the best method(s) for extracting simulated use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.

5.3 Methods describing various techniques for extracting soil are given.

5.4 Guidance is further given as to how to validate the method(s) for extraction.

Subcomité:

F04.15

Referida por:

F3438-24

Volúmen:

13.02

Número ICS:

11.080.99 (Other standards related to sterilization and disinfection)

Palabras clave:

analyte; contaminants; extract; extractant; soiling;