【国外标准】 Standard Practice for Determination of Expiration Dating for Medical Gloves

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.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 label claims and safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.3 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.