ASTM International - ASTM D7161-05
Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
|Publication Date:||15 June 2005|
|ICS Code (Hospital equipment):||11.140|
significance 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.
1.1 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 D 7160.
Note 1-Accelerated aging for three-year shelf life is described in Practice D 7160.
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.