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  • ASTM F 2097 : 2016 : REDLINE

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Design and Evaluation of Primary Flexible Packaging for Medical Products

    Available format(s):  PDF

    Superseded date:  18-09-2020

    Language(s):  English

    Published date:  01-04-2016

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 15.09, 2016 Gives directions for the design and evaluation of primary flexible packages for medical products.

    Scope - (Show below) - (Hide below)

    1.1This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.

    1.2This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.

    1.3This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.

    1.4This guide does not assess the product to be packaged or the sterilization method to be used.

    1.5The units cited in the referenced standard should be used.

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

    Committee F 02
    Document Type Redline
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By

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

    ASTM F 3263 : 2017 Standard Guide for Packaging Test Method Validation
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    ASTM F 2559/F2559M : 2006 : R2010 : EDT 1 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
    ASTM F 392/F392M : 2011 Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    ASTM F 2559/F2559M : 2006 : R2015 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
    ASTM F 99 : 2007 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
    ASTM F 99 : 2007 : R2011 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
    ASTM F 99 : 2007 : R2015 Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
    ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    ASTM F 392/F392M : 2011 : R2015 Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
    ASTM F 1980 : 2016 : REDLINE Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
    ASTM F 2559 : 2006 Standard Guide for Writing a Specification for Sterilizable Peel Pouches

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

    TAPPI T 547 : 2012 AIR PERMEANCE OF PAPER AND PAPERBOARD (SHEFFIELD METHOD)
    ASTM F 2228 : 2013 : REDLINE Standard Test Method for Non-Destructive Detection of Leaks in Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method
    ASTM F 1927 : 2014 : REDLINE Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
    ASTM D 2019 : 1997 Standard Test Method for Dirt in Paper and Paperboard
    ASTM D 1894 : 2014 : REDLINE Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
    ISTA 3E : 2017 SIMILAR PACKAGED-PRODUCTS IN UNITIZED LOADS FOR TRUCKLOAD SHIPMENT
    ASTM D 4169 : 2016 : REDLINE Standard Practice for Performance Testing of Shipping Containers and Systems
    ASTM D 3420 : 2014 : REDLINE Standard Test Method for Pendulum Impact Resistance of Plastic Film
    ASTM F 2559 : 2006 Standard Guide for Writing a Specification for Sterilizable Peel Pouches
    TAPPI T 404 : 1992 TENSILE BREAKING STRENGTH AND ELONGATION OF PAPER AND PAPERBOARD (USING PENDULUM-TYPE TESTER)
    TAPPI T 460 : 2011 AIR RESISTANCE OF PAPER (GURLEY METHOD)
    ASTM F 3136 : 2015 Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
    ASTM F 2475 : 2011 : REDLINE Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
    ISO 2556:1974 Plastics Determination of the gas transmission rate of films and thin sheets under atmospheric pressure Manometric method
    ASTM F 1443 : 1993 Standard Test Methods for Equipment and Procedures Used in Evaluating the Performance Characteristics of Protective Headgear
    EN 868-1 : 1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED - GENERAL REQUIREMENTS AND TEST METHODS
    ASTM F 2227 : 2013 : REDLINE Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
    ASTM F 2029 : 2016 : REDLINE Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
    ASTM D 4321 : 2015 : REDLINE Standard Test Method for Package Yield of Plastic Film
    ASTM F 1307 : 2014 : REDLINE Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
    ASTM D 7386 : 2016 : REDLINE Standard Practice for Performance Testing of Packages for Single Parcel Delivery Systems
    ASTM D 4279 : 1995 Standard Test Methods for Water Vapor Transmission of Shipping Containers-Constant and Cycle Methods
    ASTM F 2981 : 2015 Standard Test Method for Verifying Nonporous Flexible Barrier Material Resistance to the Passage of Air
    ASTM F 2096 : 2011 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
    MIL-M-36954 Revision C:1975 MASK, SURGICAL, DISPOSABLE
    ASTM D 2457 : 2013 : REDLINE Standard Test Method for Specular Gloss of Plastic Films and Solid Plastics
    ISO 15105-1:2007 Plastics Film and sheeting Determination of gas-transmission rate Part 1: Differential-pressure methods
    ASTM F 2476 : 2013 : REDLINE Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO2TR) Through Barrier Materials Using An Infrared Detector
    ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
    TAPPI T 536 : 2012 RESISTANCE OF PAPER TO PASSAGE OF AIR (HIGH-PRESSURE GURLEY METHOD)
    ISO 5636-5:2013 Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
    ASTM F 1608 : 2016 : REDLINE Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
    ISO 15105-2:2003 Plastics — Film and sheeting — Determination of gas-transmission rate — Part 2: Equal-pressure method
    ASTM D 1003 : 2013 : REDLINE Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
    ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
    ASTM F 1886 : 1998 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
    ASTM D 1922 : 2015 : REDLINE Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
    ASTM F 1980 : 2016 : REDLINE Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
    TAPPI T 494 : 2013 TENSILE PROPERTIES OF PAPER AND PAPERBOARD (USING CONSTANT RATE OF ELONGATION APPARATUS)
    ASTM E 398 : 2013 : REDLINE Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ASTM F 1306 : 2016 : REDLINE Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates
    ASTM F 904 : 2016 : REDLINE Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials
    ASTM F 1249 : 2013 : REDLINE Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
    ASTM D 374 : 1999 Standard Test Methods for Thickness of Solid Electrical Insulation
    ASTM D 589 : 1997 Standard Test Method for Opacity of Paper (15°Diffuse Illuminant A, 89% Reflectance Backing and Paper Backing)
    ASTM F 3039 : 2015 : REDLINE Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
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