【国外标准】 Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit

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.1.1 This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material.1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.1.4 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.