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ASTM D 7161 : 2016 : R2023

Current

Current

The latest, up-to-date edition.

Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-06-2023

€49.35
Excluding VAT

Committee
D 11
DocumentType
Standard Practice
Pages
3
PublisherName
American Society for Testing and Materials
Status
Current
Supersedes

1.1This 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 twelve 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.

1.2This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.3This 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.

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ASTM F 1929 : 2023 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM D 5151 : 2019 : R2023 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D 5151 : 2019 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D 3578 : 2019 Standard Specification for Rubber Examination Gloves
ASTM D 5250 : 2019 : R2023 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
ASTM D 6319 : 2019 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D 7160 : 2016 : R2023 Standard Practice for Determination of Expiration Dating for Medical Gloves
ASTM D 3577 : 2019 : R2023 Standard Specification for Rubber Surgical Gloves
ASTM D 6319 : 2019 : R2023 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D 3578 : 2019 : R2023 Standard Specification for Rubber Examination Gloves
ASTM D 3577 : 2019 Standard Specification for Rubber Surgical Gloves
ASTM D 5250 : 2019 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

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