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ASTM-F1264:2007 Edition

ASTM-F1264:2007 Edition

$44.96

F1264-03(2007)e2 Standard Specification and Test Methods for Intramedullary Fixation Devices

Published By Publication Date Number of Pages
ASTM 2007 18
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1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.

1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.

1.3 This specification includes four standard test methods:

1.3.1 Static Four-Point Bend Test Method Annex A1 and

1.3.2 Static Torsion Test Method Annex A2.

1.3.3 Bending Fatigue Test Method Annex A3.

1.3.4 Test Method for Bending Fatigue of IMFD Locking Screws Annex A4.

1.4 A rationale is given in Appendix X1.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

PDF Catalog

PDF Pages PDF Title
1 Scope
Referenced Documents
Terminology
2 Classification
Material
Performance Considerations and Test Methods
3 Marking, Packaging, Labeling, and Handling
Means for Insertion and Extraction
Keywords
FIG. 1
FIG. 2
4 A1. TEST METHOD FOR STATIC FOUR-POINT BEND TEST METHOD
A1.1 Scope
A1.2. Terminology
A1.3 Classification
A1.4 Procedure
5 FIG. A1.1
FIG. A1.2
6 FIG. A1.3
FIG. A1.4
7 A1.5 Number of Specimens
A1.6 Apparatus
A1.7 Precision and Bias
TABLE A1.1
8 A1.8 Report
A1.9 Rationale (Nonmandatory Information)
TABLE A1.2
TABLE A1.3
TABLE A1.4
9 A2. TEST METHOD FOR STATIC TORSIONAL TESTING OF INTRAMEDULLARY FIXATION DEVICES
A2.1 Scope
A2.2 Summary of Test Method
A2.3 Terminology
TABLE A1.5
10 A2.4 Significance and Use
A2.5 Apparatus
A2.6 Test Specimen
A2.7 Procedure
FIG. A2.1
11 A2.8 Calculation or Interpretation of Results
A2.9 Report
A2.10 Precision and Bias
FIG. A2.2
FIG. A2.2
12 A2.11 Rationale (Nonmandatory Information)
A3. TEST METHOD FOR BENDING FATIGUE TESTING OF INTRAMEDULLARY FIXATION DEVICES
A3.1 Scope
A3.2 Referenced Documents
A3.3. Terminology
FIG. A3.1
13 A3.4 Summary of Test Method
A3.5 Significance and Use
A3.6 Apparatus
A3.7 Test Specimen
A3.8 Procedure
14 A3.9 Calculation and Interpretation of Results
A3.10 Report
A3.11 Precision and Bias
A3.12 Rationale
15 A4. TEST METHOD FOR BENDING FATIGUE TESTING OF IMFD LOCKING SCREWS
A4.1 Scope
A4.2 Referenced Documents
A4.3. Terminology
A4.4 Summary of Test Method
FIG. A4.1
16 A4.5 Significance and Use
A4.6 Apparatus
A4.7 Test Specimen
A4.8 Procedure
FIG. A4.2
17 A4.9 Calculation and Interpretation of Results
A4.10 Report
A4.11 Precision and Bias
X1. RATIONALE
X1.1
X1.2
X1.3

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