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ASTM-F1541:2007 Edition

ASTM-F1541:2007 Edition

$58.50

F1541-02(2007) Standard Specification and Test Methods for External Skeletal Fixation Devices

Published By Publication Date Number of Pages
ASTM 2007 31
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1.1 This specification provides a characterization of the design and mechanical function of external skeletal fixation devices (ESFDs), test methods for characterization of ESFD mechanical properties, and identifies needs for further development of test methods and performance criteria. The ultimate goal is to develop a specification, which defines performance criteria and methods for measurement of performance-related mechanical characteristics of ESFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of the devices, as insufficient knowledge is available to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living. Furthermore, it is not the intention of this specification to describe or specify specific designs for ESFDs.

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

1.3 This specification includes a terminology and classification annex and five standard test method annexes as follows:

1.3.1 Classification of External Fixators.

1.3.2 Test Method for External Skeletal Fixator Connectors.

1.3.3 Test Method for Determining In-Plane Compressive Properties of Circular Ring or Ring Segment Bridge Elements.

1.3.4 Test Method for External Skeletal Fixator Joints.

1.3.5 Test Method for External Skeletal Fixator Pin Anchorage Elements.

1.3.6 Test Method for External Skeletal Fixator Subassemblies.

1.3.7 Test Method for External Skeletal Fixator/Constructs Subassemblies.

1.4 A rationale is given in Appendix X1.

1.5 The values stated in SI units are to be regarded as the standard.

1.6 The following safety hazards caveat pertains only to the test method portions (Annex A2 – Annex A6):

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
2 Terminology
Classification
Materials
Performance Considerations and Test Methods
Keywords
3 A1. CLASSIFICATION OF EXTERNAL SKELETAL FIXATORS
A1.1 Scope
A1.2 Referenced Documents
A1.3 Background
A1.4 Significance and Use
A1.5 Basis of Classification
4 FIG. A1.1
5 A1.6 Attributes
6 A2. TEST METHOD FOR EXTERNAL SKELETAL FIXATOR CONNECTORS
A2.1 Scope
A2.2 Referenced Documents
A2.3. Terminology
A2.4 Summary of Test Method
A2.5 Significance and Use
A2.6 Apparatus
7 A2.7 Test Specimen
A2.8 Procedure
FIG. A2.1
8 A2.9 Calculation or Interpretation of Results
FIG. A2.2
9 A2.10 Report
A2.11 Precision and Bias
12. Keywords
A2.13 Rationale
A3. TEST METHOD FOR DETERMINING IN-PLANE COMPRESSIVE PROPERTIES OF CIRCULAR RING OR RING SEGMENT BRIDGE ELEMENTS
A3.1 Scope
A3.2 Referenced Documents
A3.3. Terminology
A3.4 Summary of Test Method
A3.5 Significance and Use
10 A3.6 Apparatus
A3.7 Test Specimen
A3.8 Procedure
11 A3.9 Calculation or Interpretation of Results
A3.10 Report
FIG. A3.1
FIG. A3.2
FIG. A3.3
12 A3.11 Precision and Bias
A3.12 Rationale
A4. TEST PROCEDURE FOR EXTERNAL SKELETAL FIXATOR JOINTS
A4.1 Scope
A4.2 Referenced Documents
A4.3. Terminology
A4.4 Summary of Test Method
13 A4.5 Significance and Use
A4.6 Apparatus
A4.7 Test Specimen
A4.8 Procedure
FIG. A4.1
15 A4.9 Calculation or Interpretation of Results
A4.10 Report
A4.11 Precision and Bias
12. Keywords
A4.13 Rationale
FIG. A4.2
16 A5. TEST METHOD FOR EXTERNAL SKELETAL FIXATOR PINS
A5.1 Scope
A5.2 Referenced Documents
A5.3. Terminology
A5.4 Summary of Test Method
A5.5 Significance and Use
17 A5.6 Test Apparatus
A5.7 Test Specimen
A5.8 Procedure
FIG. A5.1
18 A5.9 Report
A5.10 Precision and Bias
11. Keywords
A5.12 Rationale
FIG. A5.2
FIG. A5.3
19 A6. TEST METHOD FOR EXTERNAL SKELETAL FIXATOR SUBASSEMBLIES
A6.1 Scope
A6.2 Referenced Documents
A6.3. Terminology
A6.4 Summary of Test Method
A6.5 Significance and Use
A6.6 Apparatus
FIG. A6.1
20 A6.7 Test Specimen
A6.8 Procedure
21 A6.9 Calculation or Interpretation of Results
A6.10 Report
FIG. A6.2
22 A6.11 Precision and Bias
A6.12 Rationale
A7. TEST METHOD FOR EXTERNAL SKELETAL FIXATOR-BONE CONSTRUCTS
A7.1 Scope
A7.2 Referenced Documents
A7.3. Terminology
23 FIG. A7.1
FIG. A7.2
FIG. A7.3
FIG. A7.4
FIG. A7.5
24 A7.4 Summary of Test Method
FIG. A7.6
FIG. A7.7
25 A7.5 Significance and Use
A7.6 Apparatus
A7.7 Sampling
A7.8 Test Specimen
26 A7.9 Construct Assembly
A7.10 Procedure
TABLE A7.1
28 A7.11 Calculation or Interpretation of Results
29 A7.12 Report
30 A7.13 Precision and Bias
14. Keywords
X1. RATIONALE
X1.1
X1.2
X1.3
X2. RATIONALE FOR ANNEX A7
X2.1
X2.2
X2.3
X2.4
31 X2.5
REFERENCES

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