Standard Test Method for Ion Release Evaluation of Medical Implants

Importancia y uso:

5.1 Components of implanted medical devices can release ions, which may lead to adverse biological effects if released in sufficient quantities. Therefore, it may be necessary to characterize the ion release behavior over time to verify that a medical device or device components, or both, will not pose an unacceptable risk to patients. Some examples of when time-dependent ion release testing should be considered include:

5.1.1 New materials,

5.1.2 New applications (for example, different in-vivo environments or new designs) that may degrade corrosion resistance,

5.1.3 Manufacturing processes that may lead to increased ion release susceptibility,

5.1.4 Results of other corrosion testing (for example, Test Methods F2129 and F3044) indicate high susceptibility to corrosion.

5.2 Forming and finishing steps used to create an implantable device may have significant effects on the ion release behavior of the material from which the device is fabricated. Preconditioning can impact the ion release behavior of implants; therefore, prior to testing, devices should be subjected to preconditioning that is appropriate to their application. A justification shall be provided if preconditioning is omitted. Additional information on preconditioning is found in Appendix X1. Substitute test articles (tubes, plates, wires, device subcomponents, etc.) may be used for testing with adequate justification, if all processing steps, including sterilization and preconditioning, are comparable to the finished device.

5.3 To accommodate the wide variety of device shapes and sizes likely to be encountered, various sizes and shapes of containers manufactured from various materials can be used. The container material choice should be justified.

5.4 Note that the test conditions described in this test method may not completely simulate those encountered in vivo (cells, proteins, mechanical loading, and other specifics of the in-vivo environment); however, the results of this testing conducted in simulated physiological solutions can provide useful data to estimate exposure as part of a risk assessment (for example, as per ISO 10993-17) or to compare different device materials, designs, or manufacturing processes.

Subcomité:

F04.15

Referida por:

F1357-23

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prosthetics and orthotics)

Palabras clave:

biocompatibility; ion release; medical device testing; metal;