ASTM-F564 2006

$44.96

F564-02(2006)e1 Standard Specification and Test Methods for Metallic Bone Staples

Published By	Publication Date	Number of Pages
ASTM	2006	12

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Categories: 11.040.30 - Surgical instruments and materials, ASTM

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Description

1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.

1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:

1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples Annex A1.

1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples Annex A2.

1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples Annex A3.

1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples Annex A4.

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

1.4 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.

A1.1.1 This test method covers procedures for the performance of constant amplitude fatigue testing of metallic staples used in internal fixation of the musculoskeletal system. This test method may be used when testing in air at ambient temperature or in an aqueous or physiological solution.

A1.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A1.1.3 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.

A2.1.1 This test method covers testing of the hard tissue pull-out fixation strength of metallic staples used in the internal fixation of the musculoskeletal system. This test method may be used with physiologic bone or a synthetic substitute. It may also be used when testing in an aqueous or physiological solution.

A2.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A2.1.3 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.

A3.1.1 This test method covers testing the soft tissue fixation strength of metallic staples used in internal fixation of the musculoskeletal system. This test method may be used with physiologic soft tissue and bone or synthetic substitutes for either, or both. This test method may also be used when testing in an aqueous or physiological solution.

A3.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

A3.1.3 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.

A4.1.1 This test method covers a procedure for determining the rigidity of bone staples.

A4.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.

A4.1.3 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 Finish Inspection Practices Care and Handling Keywords
2	A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLES A1.1 Scope A1.2 Summary of Test Method A1.3 Significance and Use A1.4 Apparatus FIG. A1.1
3	A1.5 Test Specimen A1.6 Procedure FIG. A1.2 FIG. A1.3
4	A1.7 Test Termination A1.8 Report A1.9 Precision A1.10 Rationale (Nonmandatory Information) A2. TEST METHOD FOR PULL-OUT FIXATION STRENGTH OF METALLIC BONE STAPLES A2.1 Scope A2.2 Summary of Test Method A2.3 Significance and Use
5	A2.4 Apparatus A2.5 Test Specimen A2.6 Procedure A2.7 Test Termination
6	A2.8 Report A2.9 Precision A2.10 Rationale (Nonmandatory Information) FIG. A2.1
7	A3. TEST METHOD FOR SOFT TISSUE FIXATION STRENGTH OF METALLIC BONE STAPLES A3.1 Scope A3.2 Summary of Test Method A3.3 Significance and Use A3.4 Apparatus A3.5 Test Specimen
8	A3.6 Procedure A3.7 Test Termination A3.8 Report FIG. A3.1
9	A3.9 Precision A3.10 Rationale (Nonmandatory Information) A4. TEST METHOD FOR ELASTIC STATIC BENDING OF METALLIC BONE STAPLES A4.1 Scope A4.2. Terminology A4.3 Summary of Test Method A4.4 Significance and Use A4.5 Apparatus
10	FIG. A4.1 FIG. A4.2
11	A4.6 Sampling A4.7 Procedure A4.8 Report
12	A4.9 Precision and Bias A4.10 Rationale (Nonmandatory Information) FIG. A4.3

Additional information

Standard Title	F564-02(2006)e1 Standard Specification and Test Methods for Metallic Bone Staples
Published Code	ASTM
Publication Date	2006
Pages Count	12
ICS Codes	11.040.30 - Surgical instruments and materials

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