ASTM F564-00

Standard Specification and Test Methods for Metallic Bone Staples

STANDARD published on 10.4.2002

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The information about the standard:

Designation standards: ASTM F564-00
Note: WITHDRAWN
Publication date standards: 10.4.2002
SKU: NS-55736
The number of pages: 12
Approximate weight : 36 g (0.08 lbs)
Country: American technical standard
Category: Technical standards ASTM

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Annotation of standard text ASTM F564-00 :

Keywords:

bending test, bone fixation, fatigue test, fixation devices, metallic bone staples, orthopaedic medical devices, pullout test, soft tissue fixation, surgical implants, ICS Number Code 11.040.30 (Surgical instruments and materials)

Additional information

1. Scope

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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values given in parentheses are given for information only.

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.

2. Referenced Documents

F629-20	Standard Practice for Radiography of Cast Metallic Surgical Implants
F86-21	Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
F565-21	Standard Practice for Care and Handling of Orthopedic Implants and Instruments
F382-17	Standard Specification and Test Method for Metallic Bone Plates
F601-23	Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
E4-21	Standard Practices for Force Calibration and Verification of Testing Machines
F75-23	Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
E467-21	Standard Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing System
E122-17(2022)	Standard Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot or Process

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