ASTM-F543 2007

$44.96

F543-07e1 Standard Specification and Test Methods for Metallic Medical Bone Screws

Published By	Publication Date	Number of Pages
ASTM	2007	20

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ASTM

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Description

1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.

1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:

1.2.1 Annex A1 Test Method for Determining the Torsional Properties of Metallic Bone Screws.

1.2.2 Annex A2 Test Method for Driving Torque of Medical Bone Screws.

1.2.3 Annex A3 Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.

1.2.4 Annex A4 Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.

1.2.5 Annex A5 Specifications for Type HA and Type HB Metallic Bone Screws.

1.2.6 Annex A6 Specifications for Type HC and Type HD Metallic Bone Screws.

1.2.7 Annex A7 Specifications for Metallic Bone Screw Drive Connections.

1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.

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

1.5 This standard may involve the use of hazardous materials, operations, and equipment. 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.

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PDF Pages	PDF Title
1	Scope Referenced Documents
2	Terminology FIG. 1
3	Classification Material Dimensions and Tolerances Finish and Marking Care and Handling Driving Instruments Performance Considerations and Test Methods
4	Performance Requirements Keywords A1. TEST METHOD FOR DETERMINING THE TORSIONAL PROPERTIES OF METALLIC BONE SCREWS A1.1 Significance and Use A1.2 Apparatus FIG. A1.1
5	A1.3 Procedure A1.4 Report FIG. A1.2 FIG. A1.3
6	A1.5 Precision and Bias A2. TEST METHOD FOR DRIVING TORQUE OF MEDICAL BONE SCREWS A2.1 Significance and Use A2.2 Apparatus FIG. A2.1
7	A2.3 Sampling A2.4 Procedure A2.5 Report A2.6 Precision and Bias A3. TEST METHOD FOR DETERMINING THE AXIAL PULLOUT STRENGTH OF MEDICAL BONE SCREWS A3.1 Significance and Use
8	A3.2 Apparatus A3.3 Sampling, Test Specimens, and Test Units A3.4 Procedure A3.5 Calculation or Interpretation of Results A3.6 Report FIG. A3.1
9	A3.7 Precision and Bias A4. TEST METHOD FOR DETERMINING THE SELF-TAPPING PERFORMANCE OF SELF-TAPPING MEDICAL BONE SCREWS A4.1 Significance and Use A4.2 Apparatus FIG. A4.1
10	A4.3 Sampling A4.4 Procedure A4.5 Report FIG. A4.2
11	A4.6 Precision and Bias A5. SPECIFICATIONS FOR HA AND HB METALLIC MEDICAL BONE SCREWS A5.1 Screw Classification A5.2 Screw and Thread Form Dimensions A5.3 Drive Connections A5.4 Performance Requirements
12	TABLE A5.1 FIG. A5.1 TABLE A5.2 FIG. A5.2
13	TABLE A5.3 FIG. A5.3 TABLE A5.4 FIG. A5.4 TABLE A5.5
14	A6. SPECIFICATIONS FOR HC AND HD METALLIC MEDICAL BONE SCREWS A6.1 Screw Classification A6.2 Screw and Thread Form Dimensions A6.3 Drive Connections A6.4 Performance Requirements
15	TABLE A6.1 FIG. A6.1 TABLE A6.2 FIG. A6.2 TABLE A6.3 FIG. A6.3
16	A7. SPECIFICATIONS FOR METALLIC BONE SCREW DRIVE CONNECTIONS A7.1 Scope A7.2 Classification FIG. A6.4 TABLE A6.4 FIG. A7.1 FIG. A7.2 FIG. A7.3
17	A7.3 Dimensions FIG. A7.4 FIG. A7.5 FIG. A7.6 FIG. A7.7 FIG. A7.8 TABLE A7.1
18	TABLE A7.2 TABLE A7.3 TABLE A7.4 TABLE A7.5 TABLE A7.6 TABLE A7.7
19	X1. METALLIC BONE SCREWS X1.1 X1.2 X1.3 X1.4 X1.5 TABLE A7.8
20	X1.6

Additional information

Standard Title	F543-07e1 Standard Specification and Test Methods for Metallic Medical Bone Screws
Published Code	ASTM
Publication Date	2007
Pages Count	20
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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