ASTM D 7102 - 17 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

Current edition approved May 1, 2017. Published June 2017. Originally approved in 2004. Last previous edition approved in 2010 as D7102 – 10. — 5 p.
This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate.
As bacteria may continue to grow on non-sterile gloves, reportable endotoxin levels are only appropriate for gloves labeled as sterile. Because most environments contain endotoxin, once a box of gloves is opened and the gloves are inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution.
This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations.
This guide is not applicable to the determination of pyrogens other than bacterial endotoxins.
The sample preparation method described must be used regardless of the test method selected. This method does notdescribe laboratory test
method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed.
The safe and proper use of medical gloves is beyond the scope of this guide.