• ASTM D 7161 : 2016

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

    Available format(s):  Hardcopy, PDF

    Superseded date:  13-06-2023

    Language(s):  English

    Published date:  28-06-2016

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    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

    Scope - (Show below) - (Hide below)

    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 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.

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

    General Product Information - (Show below) - (Hide below)

    Committee D 11
    Document Type Standard Practice
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM D 7103 : 2019 Standard Guide for Assessment of Medical Gloves
    ASTM D 7160 : 2016 Standard Practice for Determination of Expiration Dating for Medical Gloves

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 3078 : 2002 : R2021 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 5250 : 2000 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 5151 : 2006 Standard Test Method for Detection of Holes in Medical Gloves
    ASTM D 6319 : 2000 : REV A : EDT 1 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM F 1929 : 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ASTM D 3577 : 2009 : R2015 Standard Specification for Rubber Surgical Gloves
    ASTM D 6319 : 2010 : R2015 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 6319 : 2000 : REV A : R2005 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 3577 : 2001 Standard Specification for Rubber Surgical Gloves
    ASTM D 3577 : 2001 : EDT 1 Standard Specification for Rubber Surgical Gloves
    ASTM D 3078 : 1994 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM F 1929 : 2012 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ASTM D 3577 : 2000 Standard Specification for Rubber Surgical Gloves
    ASTM D 6319 : 2010 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 5250 : 2000 : EDT 1 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 5250 : 2006 : R2011 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 6319 : 2000 : REV A : EDT 2 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 3577 : 2009 Standard Specification for Rubber Surgical Gloves
    ASTM D 7160 : 2016 Standard Practice for Determination of Expiration Dating for Medical Gloves
    ASTM D 5151 : 2019 Standard Test Method for Detection of Holes in Medical Gloves
    ASTM D 3078 : 2002 : R2013 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 3578 : 2019 Standard Specification for Rubber Examination Gloves
    ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 7160 : 2005 Standard Practice for Determination of Expiration Dating for Medical Gloves
    ASTM D 5151 : 2006 : R2015 Standard Test Method for Detection of Holes in Medical Gloves
    ASTM D 5250 : 2006 : R2015 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 3577 : 2009 : EDT 1 Standard Specification for Rubber Surgical Gloves
    ASTM D 3578 : 2001 : REV A : EDT 2 Standard Specification for Rubber Examination Gloves
    ASTM D 3577 : 2006 Standard Specification for Rubber Surgical Gloves
    ASTM D 3578 : 2005 : EDT 1 Standard Specification for Rubber Examination Gloves
    ASTM D 3578 : 2005 : R2015 Standard Specification for Rubber Examination Gloves
    ASTM D 5250 : 2006 : EDT 1 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 3578 : 2005 : R2010 Standard Specification for Rubber Examination Gloves
    ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 3578 : 2001 : EDT 1 Standard Specification for Rubber Examination Gloves
    ASTM D 3577 : 2019 Standard Specification for Rubber Surgical Gloves
    ASTM D 3578 : 2000 : REV A Standard Specification for Rubber Examination Gloves
    ASTM D 5250 : 2019 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 3078 : 2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 6319 : 2000 : REV A : R2005 : EDT 1 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 6319 : 2000 : REV A Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 3078 : 2002 : R2008 : EDT 1 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 5151 : 1999 Standard Test Method for Detection of Holes in Medical Gloves
    ASTM D 3578 : 2005 Standard Specification for Rubber Examination Gloves
    ASTM D 3078 : 2002 : R2008 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
    ASTM D 3577 : 2001 : REV A : EDT 1 Standard Specification for Rubber Surgical Gloves
    ASTM D 3578 : 2001 : REV A Standard Specification for Rubber Examination Gloves
    ASTM D 5250 : 2000 : EDT 4 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 5151 : 2006 : R2011 Standard Test Method for Detection of Holes in Medical Gloves
    ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
    ASTM D 3577 : 2001 : REV A Standard Specification for Rubber Surgical Gloves
    ASTM D 5250 : 2000 : EDT 3 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 5250 : 2000 : EDT 2 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 3578 : 2001 : REV A : EDT 1 Standard Specification for Rubber Examination Gloves
    ASTM D 5250 : 2006 Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
    ASTM D 7160 : 2005 : R2010 Standard Practice for Determination of Expiration Dating for Medical Gloves
    ASTM D 6319 : 2000 : REV A : EDT 3 Standard Specification for Nitrile Examination Gloves for Medical Application
    ASTM D 3578 : 2001 Standard Specification for Rubber Examination Gloves
    ASTM F 1929 : 1998 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    ASTM D 3577 : 2001 : REV A : EDT 2 Standard Specification for Rubber Surgical Gloves
    ASTM D 3577 : 2006 : EDT 1 Standard Specification for Rubber Surgical Gloves
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