Document Center is acquired by Nimonik

Scope

1.1 This specification is intended to provide a characterization of the design and mechanical function of intramedullary fixation devices (IMFDs), specify labeling and material requirements, provide test methods for characterization of IMFD mechanical properties, and identify needs for further development of test methods and performance criteria. The ultimate goal is to develop a standard which defines performance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixation to bone. It is not the intention of this specification to define levels of performance or case-specific clinical performance of these devices, as insufficient knowledge to predict the consequences of the use of any of these devices in individual patients for specific activities of daily living is available. It is not the intention of this specification to describe or specify specific designs for IMFDs.

1.2 This specification describes IMFDs for surgical fixation of the skeletal system. It provides basic IMFD geometrical definitions, dimensions, classification, and terminology; labeling and material specifications; performance definitions; test methods and characteristics determined to be important to in-vivo performance of the device.

1.3 This specification includes four standard test methods:

1.3.1 Static Four-Point Bend Test MethodAnnex A1 and

1.3.2 Static Torsion Test MethodAnnex A2.

1.3.3 Bending Fatigue Test MethodAnnex A3.

1.3.4 Test Method for Bending Fatigue of IMFD Locking ScrewsAnnex A4.

1.4 A rationale is given in Appendix X1.

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

Significance and Use

A2.4.1 This test method describes a static torsional test to determine the torsional stiffness of the central and uniform portion of an intramedullary fixation device.

A2.4.2 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the devices being tested and their potential application.

Keywords

bend testing; definitions; extraction; fatigue test; fracture fixation; implants; intramedullary fixation devices; orthopaedic medical device; performance; surgical devices; terminology; test methods; torsion test; trauma; 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.