ASTM F2502-11
Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
- Standard No.
- ASTM F2502-11
- Release Date
- 2011
- Published By
- American Society for Testing and Materials (ASTM)
- Status
- Replace By
- ASTM F2502-17
- Latest
- ASTM F2502-17
- Scope
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.
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.
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.
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 and health practices and determine the applicability of regulatory limitations prior to use.
ASTM F2502-11 Referenced Document
- ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-19 Update
- ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
- ASTM E1823 Standard Terminology Relating to Fatigue and Fracture Testing
- ASTM E4 Standard Practices for Force Verification of Testing Machines
- ASTM E6 Standard Terminology Relating to Methods of Mechanical Testing
- ASTM F1088 Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
- ASTM F116 Standard Specification for Medical Screwdriver Bits
- ASTM F1185 Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants
- ASTM F1635 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
- ASTM F1839 Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- ASTM F1925 Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants
- ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
- ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
- ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ISO 13781 Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradation testing
- ISO 14630 Non-active surgical implants - General requirements
- ISO 15814 Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing
ASTM F2502-11 history
- 2017 ASTM F2502-17 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 2011 ASTM F2502-11 Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
- 2005 ASTM F2502-05(2009)e1 Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
- 2005 ASTM F2502-05 Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
