BH GSO ASTM D7102:2022

Bahraini Standard   Current Edition
· Approved on 28 April 2022 ·

Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

Hospital equipment
Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.

BH GSO ASTM D7102:2022 Files

English 5 Pages
Current Edition Reference Language

BH GSO ASTM D7102:2022 Scope

1.1 This guide covers a selection of methodologies for the determination of bacterial endotoxin on gloves when such a determination is appropriate. 1.2 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 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. 1.3 This guide may also be appropriate for internal quality control or alert purposes at different stages of manufacturing or during process change evaluations. 1.4 This guide is not applicable to the determination of pyrogens other than bacterial endotoxins. 1.5 The 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. 1.6 The safe and proper use of medical gloves is beyond the scope of this guide.

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