1.1 本规程涵盖了一种短期测试方法，用于在小型实验动物中筛选皮下组织对植入候选材料的反应。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。将与作为临床植入材料的对照材料诱发的反应进行比较，评估组织反应。 1.2 本规程以及其他适当的生物试验（包括其他ASTM试验方法）可用于评估用于制造临床应用装置的候选材料的生物相容性。它也可用于评估特殊表面纹理和已知材料制备的效果。 1.3 本规程未对材料的系统毒性、致癌性、致畸性或致突变性进行全面评估。可能需要有关最终成品材料的其他信息，例如临床相关位置的植入评估。 1.4 以国际单位制表示的数值，包括官方接受的与国际单位制一起使用的单位，应视为标准值。本标准不包括其他测量系统。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 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》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 本规程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，应根据良好的实验室规程进行。该测试可在长期测试之前进行（例如，实践 F981 )尽早消除不合适的候选材料，避免不必要的动物试验。 4.2 本规程通常可用于检测材料的毒性作用（参见 附录X1 ). 然而，它特别适用于一般情况下与皮下组织或软组织接触的材料的测试。对于拟专门插入肌肉组织的材料，实践 F763 应视为短期测试方法。 4.3 建议的植入物样本为圆柱形。可以使用特殊的槽型气缸（见图。 X2.1/ 附录X2 )允许组织互锁，使植入物保持在原位，并通过界面处的运动最小化组织刺激，否则可能导致结果差异增加。 如果使用无槽气缸（见图。 X1.2/ 附录X2 )，必须考虑植入物/组织界面的可能运动。控制气缸的形状应类似于测试气缸。 4.4 标本的表面处理类型会影响组织反应；因此，应在报告中注明编制程序。该试验可用于比较同一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。 注1: 如果该方法用于材料研究，则应考虑在植入前进行内毒素检测。

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.