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  • ASTM
    D7102-17 Standard Guide for Determination of Endotoxin on Sterile Medical Gloves (Redline)
    Edition: 2017
    $79.87
    Unlimited Users per year

Description of ASTM-D7102 2017

ASTM D7102-17

Redline Standard: Standard Guide for Determination of Endotoxin on Sterile Medical Gloves




ASTM D7102

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.

1.7 This 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.

1.8 This 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.


Keywords

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


ICS Code

ICS Number Code 11.140 (Hospital equipment)


DOI: 10.1520/D7102-17

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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