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Description of ASTM-D7102 2010ASTM D7102 - 10Standard Guide for Determination of Endotoxin on Sterile Medical GlovesActive Standard ASTM D7102 | Developed by Subcommittee: D11.40 Book of Standards Volume: 09.02 ASTM D7102Significance and Use This guide establishes a standard sample preparation method and provides a description of four established and recognized test methods for the determination of endotoxin on medical gloves. If interferences in a sample yield suspect results, a second method should be used. This guide is appropriate for testing final product that has been subjected to all processes that could influence the final endotoxin level (either microbial contamination or processing agents/raw materials contaminated with endotoxin). As raw materials and processing conditions vary from lot to lot with regard to these parameters, it is appropriate to test for endo-toxin on a routine basis if a product endotoxin claim is to be made (for example, non-pyrogenic). The user may find it beneficial to incorporate endotoxin testing for vulnerable areas of their manufacturing process as an alert mechanism. 1. 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.
ANSI Standard ANSI/AAMIST72:2002 Bacterial Endotoxins--Test Methodologies, Routine Monitoring and Alternatives to Batch TestingEN Standard EN455-3:1999 Medical Gloves for Single Use--Part 3: Requirements and Testing for Biological EvaluationKeywords endotoxin; gloves; lipopolysaccharide; LPS; non-pyrogenic; pyrogenic; Endotoxin ; ICS Code ICS Number Code 11.140 (Hospital equipment) DOI: 10.1520/D7102-10 ASTM International is a member of CrossRef. ASTM D7102The following editions for this book are also available...This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM 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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