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  • ASTM F 2502 : 2017

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    Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-09-2017

    Publisher:  American Society for Testing and Materials

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    Scope - (Show below) - (Hide below)

    1.1This specification and test methods cover the mechanical characterization of plates and screws for orthopedic internal fixation. Covered devices are fabricated from one or more hydrolytically degradable polymer (from this point on referred to as “absorbable”) resins or resin composites.

    1.2This specification establishes a common terminology to describe the size and other physical characteristics of absorbable implants and performance definitions related to the performance of absorbable devices.

    1.3This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of absorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.

    1.4This specification may not be appropriate for all absorbable devices, especially those that possess limited hydrolytic susceptibility and degrade in vivo primarily through enzymatic action. The user is cautioned to consider the appropriateness of the standard in view of the particular absorbable device and its potential application.

    1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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, health and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.7This 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.

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

    Committee F 04
    Document Type Standard
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

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

    ASTM F 561 : 2019 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants

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

    ASTM F 1185 : 2003 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 2503 : 2008 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ASTM F 1839 : 2008 : R2021 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM E 1823 : 2012 : REV : EDT 0 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2007 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2503 : 2005 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ASTM E 1823 : 2009 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2313 : 2018 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    ASTM F 1088 : 2004 : REV A : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 1635 : 2016 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    ASTM E 6 : 2002 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM F 2503 : 2013 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ASTM F 1839 : 2008 : EDT 2 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
    ASTM F 2579 : 2008 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM E 122 : 2017 : R2022 Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM E 122 : 2017 Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process
    ASTM F 1088 : 2004 : REV A Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 2902 : 2016 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM F 1839 : 1997 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM F 1839 : 2001 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM F 1925 : 2017 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM E 1823 : 2005 : REV A : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1925 : 1999 : EDT 1 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
    ASTM E 1823 : 2010 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2021 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 543 : 2002 : EDT 1 Standard Specification and Test Methods for Metallic Medical Bone Screws
    ASTM E 1823 : 2009 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2503 : 2020 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ASTM F 2313 : 2010 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    ASTM E 1823 : 2012 : REV D Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 3160 : 2016 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
    ASTM F 1839 : 2008 : R2012 : EDT 1 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM F 2313 : 2008 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    ASTM E 1823 : 2012 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 382 : 2017 Standard Specification and Test Method for Metallic Bone Plates
    ASTM E 6 : 2015 : EDT 3 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM F 1839 : 2008 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
    ASTM F 1925 : 2022 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM F 1635 : 1995 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
    ASTM F 565 : 2021 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
    ASTM F 1635 : 2004 Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    ASTM F 1088:2004 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM E 4 : 2021 Standard Practices for Force Calibration and Verification of Testing Machines
    ASTM E 1823 : 1996 : R2002 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 1996 : EDT 1 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 2902 : 2016 : EDT 1 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM E 1823 : 2012 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM E 1823 : 2007 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1839 : 2001 : R2007 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
    ASTM F 1088 : 2004 : REV A : R2010 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM F 2579 : 2010 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM F 2313 : 2008 : EDT 1 Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    ASTM E 6 : 2015 : EDT 4 Standard Terminology Relating to Methods of Mechanical Testing
    ASTM F 2579 : 2006 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM F 1925 : 2009 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM F 2579 : 2018 Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    ASTM F 2313 : 2003 Standard Specification for Virgin Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70% Glycolide
    ASTM F 1839 : 2008 : EDT 1 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments
    ASTM F 565 : 2004 : R2018 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
    ASTM F 1839 : 2008 : R2016 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM F 3160 : 2021 Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
    ASTM F 2902 : 2012 Standard Guide for Assessment of Absorbable Polymeric Implants
    ASTM F 116 : 2012 : R2016 Standard Specification for Medical Screwdriver Bits
    ASTM E 1823 : 2013 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1185 : 2003 : R2014 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 1088 : 1987 : R1992 : EDT 1 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM E 1823 : 2012 : REV C Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1635 : 2011 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    ASTM F 1185 : 2003 : R2009 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM E 1823 : 2020 : REV B Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1635 : 2004 : REV A Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
    ASTM F 1088 : 2018 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
    ASTM E 1823 : 2005 : REV A Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 1925 : 1999 : R2005 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
    ASTM F 1839 : 2008 : R2012 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
    ASTM E 1823 : 2011 Standard Terminology Relating to Fatigue and Fracture Testing
    ASTM F 116 : 2012 : R2021 Standard Specification for Medical Screwdriver Bits
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