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Description of ASTM-D7160 2010ASTM D7160 - 05(2010)Standard Practice for Determination of Expiration Dating for Medical GlovesActive Standard ASTM D7160 | Developed by Subcommittee: D11.40 Book of Standards Volume: 09.02 ASTM D7160Abstract This practice establishes methods for testing and determination of expiration dating of medical gloves. This covers all surgeon's and examination gloves made from either synthetic or natural rubber latex. Gloves shall be tested for stability and shelf life in accordance with the test method requirements. Expiration date shall be determined from accelerated stability tests and real time aging test. This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date. 1. Scope 1.1 This practice covers all surgeon's and examination gloves made from either synthetic or natural rubber latex. The purpose of this practice is to establish methods for testing medical gloves and analyzing the data to determine their shelf life. 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 D573 Test Method for Rubber--Deterioration in an Air Oven 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 D7161 Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions F88 Test Method for Seal Strength of Flexible Barrier Materials F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration F1980 Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ISO Standards ISO4074 Natural Latex Rubber Condoms--Requirements and Test MethodsKeywords expiration date; medical gloves; shelf life; Examination gloves (medical); Expiration dating; Medical examination gloves; Shelf life; ICS Code ICS Number Code 11.140 (Hospital equipment) DOI: 10.1520/D7160-05R10 ASTM International is a member of CrossRef. ASTM D7160This 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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