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  • ASTM F 2559/F2559M : 2006 : R2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Guide for Writing a Specification for Sterilizable Peel Pouches

    Available format(s):  Hardcopy, PDF

    Superseded date:  06-01-2022

    Language(s):  English

    Published date:  14-10-2015

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 15.09, 2016 Describes the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices.

    Scope - (Show below) - (Hide below)

    1.1This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.

    1.2Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.

    1.3Pouch materials may be either porous, nonporous, or any combination of the two.

    1.4This guide addresses some critical printing requirements on the pouch.

    1.5The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

    1.6This 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 F 02
    Development Note Supersedes ASTM F 2559. (12/2010)
    Document Type Guide
    Product Note Reconfirmed 2015
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM F 2475 : 2020 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    ASTM F 1140 : 2000 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
    ASTM F 2097 : 2010 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM E 122 : 2017 : REDLINE Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM F 2054 : 2007 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
    ASTM F 2475 : 2011 : REDLINE Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    ASTM F 2054 : 2007 : R2012 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
    ASTM F 2203 : 2002 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2054 : 2000 : R2005 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
    ASTM F 2097 : 2014 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM F 2097 : 2016 : REDLINE Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM F 2250 : 2013 : R2018 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
    ASTM F 1140 : 2000 : R2005 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
    ASTM F 2097 : 2008 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM F 2054 : 2000 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
    ASTM F 2097 : 2016 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM F 1886 : 1998 : R2004 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
    ASTM F 2475 : 2011 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    ASTM F 1140 : 2007 : R2012 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
    ASTM F 2203 : 2002 : EDT 1 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2097 : 2007 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
    ASTM F 1886 : 1998 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
    ASTM F 2203 : 2013 : R2018 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2250 : 2013 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
    ASTM F 2203 : 2013 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2250 : 2003 : R2008 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
    ASTM F 2250 : 2003 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
    ASTM F 1140 : 2007 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
    ASTM F 2203 : 2002 : R2012 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2475 : 2005 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    ASTM F 2097 : 2001 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
    ASTM F 2203 : 2002 : R2007 Standard Test Method for Linear Measurement Using Precision Steel Rule
    ASTM F 2097 : 2005 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
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