Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

Importancia y uso:

5.1 This guide establishes a standard sample preparation method and provides a description of three established and recognized test methods for the determination of endotoxin on medical gloves. If interferences in a sample yield suspect results, a second method should be used.

5.2 This guide is appropriate for testing final product that has been subjected to all processes that could influence the final endotoxin level (either microbial contamination or processing agents/raw materials contaminated with endotoxin). As raw materials and processing conditions vary from lot to lot with regard to these parameters, it is appropriate to test for endotoxin on a routine basis if a product endotoxin claim is to be made (for example, non-pyrogenic). The user may find it beneficial to incorporate endotoxin testing for vulnerable areas of their manufacturing process as an alert mechanism.

Subcomité:

D11.40

Referida por:

D7103-19R23

Volúmen:

09.02

Número ICS:

11.140 (Hospital equipment)

Palabras clave:

endotoxin; gloves; lipopolysaccharide; LPS; non-pyrogenic; pyrogenic;