1.1 本实践涵盖了一种短期测试方法，用于筛选小型实验动物对植入候选材料的皮下组织反应。材料可以是致密的或多孔的。根据吸收动力学，该方法可能不适用于可吸收材料。将与接受为临床植入材料的对照材料诱发的组织反应进行比较，评价组织反应。 1.2 该实践以及其他适当的生物学试验（包括其他ASTM试验方法）可用于评估用于临床应用器械制造的候选材料的生物相容性。它还可以用于评估特殊表面纹理和已知材料制备的效果。 1.3 该实践未提供对材料的全身毒性、致癌性、致畸性或致突变性的全面评估。可能需要关于最终成品材料的其他信息，例如在临床相关部位的植入评估。 1.4 以SI单位表示的值，包括正式接受用于SI的单位，应被视为标准值。本标准中不包括其他测量系统。 1.5 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 本规范是短期筛选试验的指南，用于评估组织对可能选择植入人体的材料的反应，应按照药物非临床研究质量管理规范进行。该测试可在长期测试（例如，实践 F981 ）早期淘汰不合适的候选材料，避免不必要的动物试验。 4.2 这种做法可用于检测一般材料的毒性作用（见 附录X1 ).然而，它特别适合于测试通常与皮下组织或软组织接触的材料。对于打算专门插入肌肉组织的材料，实践 F763 应该被认为是一个短-术语测试方法。 4.3 建议的植入物标本为圆柱形。可以使用特殊的带槽类型的圆柱体（见图X2.1 附录X2 )以允许组织互锁，该组织互锁可将植入物保持在适当位置，并通过在界面处的运动使组织刺激最小化，否则可能导致结果的变化增加。如果使用无槽圆柱体（见图X1.2 附录X2 ），必须考虑植入物/组织界面处的可能运动。控制气缸的形状应与测试气缸相似。 4.4 标本表面制备的类型会影响组织反应；因此，应在报告中注明制备程序。该测试可用于比较相同材料的不同表面结构或条件的效果或评估材料改性的各种处理的效果。附注1: 如果该方法用于材料研究，应考虑在植入前进行内毒素检查。

1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to implant candidate materials in small laboratory animals. The material may be dense or porous. This method may not work for absorbable materials, depending on the absorption kinetics. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials. 1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may also be applied to evaluate the effect of special surface textures and preparations of known materials. 1.3 This practice does not provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Additional information may be needed on the material in its final finished form, such as implantation assessment at the clinically relevant location. 1.4 The values stated in SI units, including units officially accepted for use with SI, are to be regarded as standard. No other systems of measurement are included in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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. ====== Significance And Use ====== 4.1 This practice is a guideline for a short-term screening test for the evaluation of the tissue response to materials that may be selected for implantation in the human body and should be done in accordance with good laboratory practices. This test may be performed prior to long-term testing (for example, Practice F981 ) to eliminate unsuitable candidate materials early and to avoid unnecessary animal testing. 4.2 This practice may be used to detect toxic effects of materials in general (see Appendix X1 ). However, it is particularly suitable for the testing of materials that are intended to have contact with subcutaneous tissues or soft tissues in general. For materials intended to be inserted specifically into muscle tissues, Practice F763 should be considered as a short-term test method. 4.3 The suggested implant specimens are cylindrical. A special grooved type of cylinder may be used (see Fig. X2.1 of Appendix X2 ) to allow tissue interlocking that could keep the implant in place and minimize tissue irritation through motion at the interface that otherwise could contribute to increased variance of the results. In case ungrooved cylinders are used (see Fig. X1.2 of Appendix X2 ), probable motion at the implant/tissue interface must be taken into account. Control cylinders should be shaped like the test cylinders. 4.4 The type of surface preparation of the specimens can affect the tissue reaction; therefore the preparation procedure should be noted in the report. The test may be used to compare the effect of different surface structures or conditions of the same material or to assess the effect of various treatments of modifications of a material. Note 1: If this method is used for material research, testing for endotoxin prior to implantation should be considered.