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ASTM International - ASTM F2502-17

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

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Organization: ASTM International
Publication Date: 1 September 2017
Status: active
Page Count: 12
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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... View More

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.

Document History

ASTM F2502-17
September 1, 2017
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
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...
June 1, 2011
Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
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...
August 1, 2009
Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
1.1 This specification and test methods covers a mechanical characterization reference for hydrolytically degradable polymer resin (from this point on referenced as “bioabsorbable”) plates and screws...
October 1, 2005
Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
1.1 This specification and test methods covers a mechanical characterization reference for hydrolytically degradable polymer resin (from this point on referenced as "bioabsorbable") plates and screws...
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