GSO ASTM D7102:2021
Gulf Standard
Current Edition
·
Approved on
01 July 2021
·
Standard Guide for Determination of Endotoxin on Sterile Medical Gloves
GSO ASTM D7102:2021 Files
English
5 Pages
Current Edition
Reference Language
GSO ASTM D7102:2021 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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