Standard Guide for Detection and Quantification of Cleaning Markers (Analytes) for the Validation of Cleaning Methods for Reusable Medical Devices

Importancia y uso:

5.1 This standard 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 appropriate method(s) for detecting and quantifying markers for the simulated-use test soil (see Guide F3208), thereby evaluating whether the medical device can be adequately cleaned.

5.3 This guide describes various test methods for the different analytes.

5.4 This guide specifies the validation criteria for analyte detection methods.

Subcomité:

F04.15

Volúmen:

13.02

Número ICS:

11.040.01 (Medical equipment in general), 11.080.01 (Sterilization and disinfection in general)

Palabras clave:

analyte; carbohydrates; hemoglobin; protein; total organic carbon (TOC);