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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.
Significance and Use
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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
ISO StandardsISO4074 Natural Latex Rubber Condoms--Requirements and Test Methods
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
ICS Number Code 11.140 (Hospital equipment)
UNSPSC Code 42132203(Medical exam or non surgical procedure gloves)