ASTM D7161-16 PDF

Scope: 4.1 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 D7160.

Note 1: Accelerated 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 D7161-16 Referenced Document

ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D3577 Standard Specification for Rubber Surgical Gloves
ASTM D3578 Standard Specification for Rubber Examination Gloves
ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D5250 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D7160 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
ISO 2859 Sampling procedures and tables for inspection by attributes — Addendum 1

2023 ASTM D7161-16(2023) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
2016 ASTM D7161-16 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
2005 ASTM D7161-05(2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions
2005 ASTM D7161-05 Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions