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

ASTM-F543 - 2023 EDITION - CURRENT -- See the following: ASTM-F114 ASTM-F115
Show Complete Document History

Document Center Inc. is an authorized dealer of ASTM standards.
The following bibliographic material is provided to assist you with your purchasing decision:

Standard Specification and Test Methods for Metallic Medical Bone Screws
ORDER

Price:

$90.00        


Want this as a site license?

Scope

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—Specifications for Type HA and Type HB Metallic Bone Screws.

1.2.5 Annex A5—Specifications for Type HC and Type HD Metallic Bone Screws.

1.2.6 Annex A6—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 Unless otherwise indicated, the values stated in SI units are to be regarded as standard. The values in parentheses are given for information only.

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.

Keywords

bone screw; dimensions; insertion; performance requirements; pullout; static; test methods; torsion; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

 

Customers who bought this document also bought:

ASTM-A240
Standard Specification for Chromium and Chromium-Nickel Stainless Steel Plate, Sheet, and Strip for Pressure Vessels and for General Applications

ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM-A276
Standard Specification for Stainless Steel Bars and Shapes

Document Number

ASTM-F0543-23

Revision Level

2023 EDITION

Status

Current

Modification Type

Revision with Title Change

Publication Date

July 6, 2023

Document Type

Specification

Page Count

22 pages

Committee Number

F04.21