ASTM-F2502 2005

$44.96

F2502-05 Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants

Published By	Publication Date	Number of Pages
ASTM	2005	11

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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 covers a mechanical characterization reference for hydrolytically degradable polymer resin (from this point on referenced as ‘bioabsorbable’) plates and screws for orthopedic internal fixation.

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

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

1.4 This specification may not be appropriate for all bioabsorbable devices. The user is cautioned to consider the appropriateness of the standard in view of the particular bioabsorbable device and its potential application.

1.5 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.

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

Additional information

Standard Title	F2502-05 Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants
Published Code	ASTM
Publication Date	2005
Pages Count	11
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ASTM-F2502 2005

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