Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

Importancia y uso:

4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to evaluate any irritation caused by device materials by gross assessment.

4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of this practice in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.

Note 1: Some materials (e.g., absorbables) may result in an extract pH (e.g., ≤2.0 or ≥11.5) that cannot be used with this practice.

4.3 The only applicable limitation is the extract preparation. Refer to Section 4.3 of Practice F619 for a description of this limitation.

Subcomité:

F04.16

Referida por:

F2064-17, F0748-16, F2565-21, F0451-21, F0648-21, F2103-18, F2347-24, F2695-12R20, F2759-19, F3089-23, F2212-20

Volúmen:

13.01

Número ICS:

11.220 (Veterinary medicine)

Palabras clave:

acute toxicity tests; biocompatibility; intracutaneous injection; rabbits; test animals ;