| ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws |
| Recognition Number | Orthopedic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 11-327 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.3040 | Pin, Fixation, Threaded | Class 2 | JDW |
| §888.3040 | Screw, Fixation, Bone | Class 2 | HWC |
| §888.3030 | Plate, Fixation, Bone | Class 2 | HRS |
| Reviews Guidance Checklist for Orthopedic External Fixation Devices Version #5, 2/21/97 |