Standard Practice for Characterization of Particles

Importancia y uso:

5.1 The biological response to materials in the form of small particles, as produced from implant wear, abrasion, or erosion, often is significantly different from that to the same materials in bulk form (that is, an implant component). Additionally, the morphology (for example, size and shape, surface characteristics), volume distribution, and species of these particles are major determinants of device-related biological responses; therefore, this practice provides standardized nomenclature for describing particles. Such a unified nomenclature will be of value in interpretation of biological tests of responses to particles, in that it will facilitate separation of biological responses per different particle characteristics such as size, shape, and volume.

5.2 Particles released due to wear from implants in vivo may result in an adverse biological response which will affect the long-term survival of the device. Characterization of such particles will provide valuable information regarding the safety and effectiveness of device designs or methods of processing components and the mechanisms of wear.

5.3 The morphology of particles produced in laboratory tests of wear and abrasion often is affected by the test conditions, such as the magnitude and rate of load application, device configuration, and test environment. Comparison of the morphology, size, and quantity of particles produced in vitro with those produced in vivo will provide valuable information regarding the degree to which the method simulates the in vivo condition being modeled.

5.4 Particles harvested from particle-release studies (for example, cell culture experiments, third body wear simulation) that are to be used for testing should be representative of the entire spectrum of possible particles produced from clinical use of the device/material under review (for example, due to wear, abrasion, or erosion). Therefore, efforts should be made to ensure that the particles for testing were produced from in vivo / in vitro studies that mimicked the clinical use conditions as much as possible. When there is uncertainty regarding the characteristics of particles produced from in vitro or bench testing, particles from clinical studies (for example, retrievals) can be used to enhance the clinical representativeness of testing and its predictive power for characterizing potential biological responses.

Subcomité:

F04.16

Referida por:

F2847-17, F2665-21, F3018-17, F2603-06R20, F0748-16, E3351-22, F3047M-23, F1903-18, F2027-16, F2624-12R20, E3238-20, F2789-10R20, F3295-18, E2524-22, F2423-11R20, F3335-20, E2526-22, E2490-09R21, F1904-23, F0561-19, F2694-16R20

Volúmen:

13.01

Número ICS:

19.120 (Particle size analysis. Sieving)

Palabras clave:

biocompatibility; morphology; particles; SEM; TEM; wear;