ASTM F564-17
Standard Specification and Test Methods for Metallic Bone Staples
- Standard No.
- ASTM F564-17
- Release Date
- 2017
- Published By
- American Society for Testing and Materials (ASTM)
- Latest
- ASTM F564-17
- Scope
- 1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal 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. Any other units of measurement included in this standard are shown for reference only. 1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 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, health and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
ASTM F564-17 Referenced Document
- ASTM E122 Standard Practice for Calculating Sample Size to Estimate, With a Specified Tolerable Error, the Average for Characteristic of a Lot or Process
- ASTM E4 Standard Practices for Force Verification of Testing Machines
- ASTM E467 Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
- ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- ASTM F382 Standard Specification and Test Method for Metallic Bone Plates
- ASTM F565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- ASTM F601 Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
- ASTM F629 Standard Practice for Radiography of Cast Metallic Surgical Implants
- ASTM F75 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
- ASTM F86 Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
ASTM F564-17 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
