Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials

Importancia y uso:

4.1 The use of in vivo implantation techniques for characterizing the biocompatibility of implantable materials to be utilized in various medical applications enables the assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density, hardness, surface finish) can influence the type and severity of the tissue response to the test materials.

4.2 This practice is intended as a short-term screening procedure for determining the acceptability of candidate materials. It may be utilized prior to using the long-term tests described in Practice F981. It is recommended that for some applications, additional tests, including long-term implantation studies, may be required to assess the final suitability of the candidate materials.

4.3 This practice 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 materials being tested, their potential applications, and the recommendations contained in Practice F748.

Subcomité:

F04.16

Referida por:

F2064-17, F2224-09R20, F0748-16, F2565-21, F0451-21, F0648-21, F2103-18, F2347-24, F1983-23, F0981-23, F2695-12R20, F2759-19, F1408-20A, E3219-20, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

biocompatibility; biomaterials; New Zealand white rabbits; orthopedic medical devices; paravertebral muscles; short-term implantation; tissue compatibility;