ASTM F2502-17
(Specification)Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
SIGNIFICANCE AND USE
4.1 Absorbable devices are intended to degrade and absorb over time once they are implanted into the body. This makes a removal operation unnecessary, which is especially advantageous for pediatric patients.
4.2 While the polymer degrades due to hydrolytic reaction with the environment, the mechanical performance of the device also deteriorates. The key to developing mechanically effective fracture fixation systems based on absorbable devices is to provide an adequate level of fixation strength and stiffness for a time frame that exceeds that expected for fracture healing. Once the fracture is healed, the device can be completely absorbed by the body. The biological performance of the device, particularly for application at a bony site, may be enhanced by incorporation of bioactive fillers in the polymer.
4.3 Absorbable devices will be tested using test methods that are similar to those used to evaluate conventional metallic devices. The pre-test conditioning requirements, handling requirements, and time-dependent mechanical property evaluations for absorbable devices shall be considered.
4.4 This specification and accompanying test methods are intended to complement the more general considerations for the assessment of absorbable polymeric implants that are described within Guide F2902.
FIG. 1 Screw Parameters
SCOPE
1.1 This 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.
1.2 This 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.
1.3 This 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.
1.4 This 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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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.
1.7 This 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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This 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.
Designation:F2502 −17
Standard Specification and Test Methods for
Absorbable Plates and Screws for Internal Fixation
1
Implants
This standard is issued under the fixed designation F2502; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2. Referenced Documents
2
1.1 This specification and test methods cover the mechani- 2.1 ASTM Standards:
calcharacterizationofplatesandscrewsfororthopedicinternal D790 Test Methods for Flexural Properties of Unreinforced
fixation. Covered devices are fabricated from one or more and Reinforced Plastics and Electrical Insulating Materi-
hydrolytically degradable polymer (from this point on referred als
to as “absorbable”) resins or resin composites. E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
1.2 This specification establishes a common terminology to
E122 Practice for Calculating Sample Size to Estimate,With
describe the size and other physical characteristics of absorb-
Specified Precision, the Average for a Characteristic of a
able implants and performance definitions related to the
Lot or Process
performance of absorbable devices.
E1823 TerminologyRelatingtoFatigueandFractureTesting
1.3 This specification establishes standard test methods to
F116 Specification for Medical Screwdriver Bits
consistently measure performance-related mechanical charac-
F382 SpecificationandTestMethodforMetallicBonePlates
teristics of absorbable devices when tested under defined
F543 Specification and Test Methods for Metallic Medical
conditions of pretreatment, temperature, humidity, and testing
Bone Screws
machine speed.
F565 PracticeforCareandHandlingofOrthopedicImplants
1.4 This specification may not be appropriate for all absorb- and Instruments
F1088 Specification for Beta-Tricalcium Phosphate for Sur-
able devices, especially those that possess limited hydrolytic
susceptibility and degrade in vivo primarily through enzymatic gical Implantation
F1185 Specification for Composition of Hydroxylapatite for
action.The user is cautioned to consider the appropriateness of
Surgical Implants
the standard in view of the particular absorbable device and its
potential application. F1635 Test Method for in vitro Degradation Testing of
HydrolyticallyDegradablePolymerResinsandFabricated
1.5 The values stated in SI units are to be regarded as
Forms for Surgical Implants
standard. No other units of measurement are included in this
F1839 Specification for Rigid Polyurethane Foam for Use as
standard.
a Standard Material for Testing Orthopaedic Devices and
1.6 This standard does not purport to address all of the
Instruments
safety concerns, if any, associated with its use. It is the
F1925 SpecificationforSemi-CrystallinePoly(lactide)Poly-
responsibility of the user of this standard to establish appro-
mer and Copolymer Resins for Surgical Implants
priate safety, health and environmental practices and deter-
F2313 Specification for Poly(glycolide) and Poly(glycolide-
mine the applicability of regulatory limitations prior to use.
co-lactide) Resins for Surgical Implants with Mole Frac-
1.7 This international standard was developed in accor-
tions Greater Than or Equal to 70 % Glycolide
dance with internationally recognized principles on standard-
F2503 Practice for Marking Medical Devices and Other
ization established in the Decision on Principles for the
Items for Safety in the Magnetic Resonance Environment
Development of International Standards, Guides and Recom-
F2579 Specification for Amorphous Poly(lactide) and
mendations issued by the World Trade Organization Technical
Poly(lactide-co-glycolide) Resins for Surgical Implants
Barriers to Trade (TBT) Committee.
F2902 Guide for Assessment of Absorbable Polymeric Im-
plants
1
This specification and test methods is under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and is the direct
2
responsibility of Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Sept. 1, 2017. Published October 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2011 as F2502 – 11. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2502-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2502 − 11 F2502 − 17
Standard Specification and Test Methods for
Absorbable Plates and Screws for Internal Fixation
1
Implants
This standard is issued under the fixed designation F2502; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This 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.
1.2 This 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.
1.3 This 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.
1.4 This 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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This 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 safety, health and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 This 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.
2. Referenced Documents
2
2.1 ASTM Standards:
D790 Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
E4 Practices for Force Verification of Testing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or
Process
E1823 Terminology Relating to Fatigue and Fracture Testing
F116 Specification for Medical Screwdriver Bits
F382 Specification and Test Method for Metallic Bone Plates
F543 Specification and Test Methods for Metallic Medical Bone Screws
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F1088 Specification for Beta-Tricalcium Phosphate for Surgical Implantation
F1185 Specification for Composition of Hydroxylapatite for Surgical Implants
F1635 Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for
Surgical Implants
1
This specification and test methods is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility
of Subcommittee F04.21 on Osteosynthesis.
Current edition approved June 1, 2011Sept. 1, 2017. Published July 2011October 2017. Originally approved in 2005. Last previous edition approved in 20092011 as
ε1
F2502 – 05 (2009)F2502 – 11. . DOI: 10.1520/F2502-11.10.1520/F2502-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2502 − 17
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and
Instruments
F1925 Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
F2313 Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Su
...
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