Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications

Importancia y uso:

5.1 This practice is a guideline for a screening test of candidate materials or assessment of local tissue response to absorbable medical devices which are expected to undergo complete absorption within three years.

5.2 This practice is similar to those for studies on candidate materials or medical devices that are not absorbable, such as those specified in Practices F763, F981, and F1408; however, analysis of the host response must take into account the effect of degradation and degradation products on the inflammatory response at the local tissue site and on subsequent healing of the implantation site, as well as the potential for adverse distal tissue effects.

5.3 For testing of absorbable medical devices, the test article for implantation should be in the final finished form as for intended use, including packaging and sterilization (if applicable). Configurations specific to the animal study may be needed. The test article’s surface-area-to-body mass or mass-to-body mass ratios within the animal model should be established by calculating based on surface-area-to-body mass or mass-to-body mass ratios in humans during the device’s intended clinical use. Worst-case clinical dose should be considered in the study design. For implantation studies incorporating evaluation of both local tissue responses and systemic toxicity, exaggerated material surface area or mass-to-body mass ratios (for example, a 2X to 10X safety factor to assess implant safety for regulatory submissions) compared to clinical use (for example, largest device size, maximum number of devices) should be considered, unless otherwise justified. For example, implantation of exaggerated doses may not be feasible in the selected animal model. For some devices, additional animal group(s) for exaggerated conditions should be considered if dose response information is needed. Additionally, for some devices, exaggerated dose at a specific implantation site can also be used to evaluate local tissue responses.

5.4 Materials that are designed for use in devices with in situ polymerization shall be introduced in a manner such that in situ polymerization occurs. Additional testing of individual precursor components or partially polymerized materials may be needed in some cases (for example, if testing of the final implant indicates an adverse response or incomplete polymerization).

Subcomité:

F04.16

Referida por:

F3515-21, F2884-21, F0748-16, F3510-21, F2902-16E01, F2721-09R23, F2150-19, E3219-20, F3089-23, F3659-24

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

absorbables; biocompatibility; degradables; implantation;