ASTM-F2502 2011

$44.96

F2502-11 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

Published By	Publication Date	Number of Pages
ASTM	2011	12

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	Scope Referenced Documents Terminology
2	Significance and Use Materials and Manufacture General Requirements and Performance Considerations FIG. 1
3	General Sampling, Conditioning, and Testing Considerations
4	Keywords A1. TEST METHOD FOR DETERMINING THE TORSIONAL PROPERTIES OF ABSORBABLE BONE SCREWS A1.1 Scope A1.2 Apparatus A1.3 Testing A1.4 Procedure FIG. A1.1
5	A1.5 Report A1.6 Precision and Bias A2. TEST METHOD FOR DRIVING TORQUE OF ABSORBABLE BONE SCREWS A2.1 Scope A2.2 Testing A2.3 Procedure FIG. A1.2
6	A2.4 Report A2.5 Precision and Bias A3. TEST METHOD FOR AXIAL PULLOUT OF ABSORBABLE BONE SCREWS A3.1 Scope A3.2 Apparatus FIG. A2.1
7	A3.3 Procedure A3.4 Calculation or Interpretation of Results A3.5 Report FIG. A3.1
8	A3.6 Precision and Bias A4. TEST METHOD FOR SINGLE CYCLE BEND TESTING OF ABSORBABLE BONE PLATES A4.1 Scope A4.2 Terminology A4.3 Apparatus FIG. A4.1
9	A4.4 Sampling A4.5 Procedure FIG. A4.2 FIG. A4.3
10	A4.6 Report A4.7 Precision and Bias
11	X1. RATIONALE X1.1 General Discussion X1.2 X1.3 X1.4 X1.5 Nomenclature

Additional information

Standard Title	F2502-11 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Published Code	ASTM
Publication Date	2011
Pages Count	12
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2502 2011

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