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Description of ASTM-D7161 2010ASTM D7161 - 05(2010)Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse ConditionsActive Standard ASTM D7161 | Developed by Subcommittee: D11.40 Book of Standards Volume: 09.02 ASTM D7161Significance and Use This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions. 1. Scope 1.1 This practice covers all surgeon's and examination gloves, made from either synthetic or natural rubber latex, marketed at the time this practice is published, for which there is no previous real time aging data available, and for which there are at least 12 months of storage as finished goods under typical warehouse conditions. This practice describes how to develop real time aging data for gloves that are part of finished goods inventory (including gloves that may no longer be manufactured) in order to verify the estimated expiration date (see Note 1). Manufacturers may use this data as a starting point for real time aging studies as described in Practice D7160 . Note 1Accelerated aging for three-year shelf life is described in Practice D7160 . 1.2 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 limitations prior to use.
ASTM Standards D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers--Tension D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission D3577 Specification for Rubber Surgical Gloves D3578 Specification for Rubber Examination Gloves D5151 Test Method for Detection of Holes in Medical Gloves D5250 Specification for Poly(vinyl chloride) Gloves for Medical Application D6319 Specification for Nitrile Examination Gloves for Medical Application D7160 Practice for Determination of Expiration Dating for Medical Gloves F88 Test Method for Seal Strength of Flexible Barrier Materials F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Keywords expiration date; medical gloves; shelf life; storage conditions; Medical examination gloves; Examination gloves (medical); Storage stability; Expiration dating ; ICS Code ICS Number Code 11.140 (Hospital equipment) DOI: 10.1520/D7161-05R10 ASTM International is a member of CrossRef. ASTM D7161This 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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