1.1This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate.
1.2As 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 manipulated, endotoxin levels will increase making it inappropriate to report endotoxin levels on boxed gloves (ex. examination gloves). This is true even if the box had undergone sterilization prior to distribution.
1.3This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations.
1.4This guide is not applicable to the determination of pyrogens other than bacterial endotoxins.
1.5The sample preparation method described must be used regardless of the test method selected. This method does not describe laboratory test method validation, analyst qualification, or reagent confirmation. Product-specific validation is addressed.
1.6The safe and proper use of medical gloves is beyond the scope of this guide.
1.7This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use.
1.8This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.