ASTM F564-10
Standard Specification and Test Methods for Metallic Bone Staples

Standard No.
ASTM F564-10
Release Date
2010
Published By
American Society for Testing and Materials (ASTM)
Status
Replace By
ASTM F564-10(2015)
Latest
ASTM F564-17
Scope

A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.

A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.

A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.

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 StaplesAnnex A1.

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

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

1.2.4 Test Method for Elastic Static Bending of Metallic Bone StaplesAnnex 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. ......

ASTM F564-10 history

  • 2017 ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples
  • 2015 ASTM F564-10(2015) Standard Specification and Test Methods for Metallic Bone Staples
  • 2010 ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples
  • 2002 ASTM F564-02(2006)e1 Standard Specification and Test Methods for Metallic Bone Staples
  • 2002 ASTM F564-02(2006) Standard Specification and Test Methods for Metallic Bone Staples
  • 2002 ASTM F564-02 Standard Specification and Test Methods for Metallic Bone Staples
  • 2002 ASTM F564-00 Standard Specification and Test Methods for Metallic Bone Staples



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