1.1 本规程为组织对医疗器械植入物的非吸收性反应的生物学评估提供了指南。它评估肌肉内或骨内植入材料的效果。该实验方案并非旨在对材料的全身毒性、免疫反应、致癌性或致突变性进行全面评估，因为其他标准也涉及这些问题。它仅适用于预计在人类中应用的材料，其中材料将在骨骼或骨骼肌组织中停留超过30天。在其他器官系统或组织中的应用可能是不合适的，因此被排除在外。对照材料通过井识别- 以长期响应为特征，可包括金属和规范中的任何一种金属合金 F67 ， F75 ， F90 ， F136 ， F138 或 F562 ，规范中所述的高纯度致密氧化铝 F603 ，规范中规定的超高分子量聚乙烯 F648 ，或USP聚乙烯阴性对照。 1.2 以国际单位制表示的数值，包括正式接受与国际单位制一起使用的单位，应视为标准。本标准不包括其他测量系统。 1.3 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者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。 1.4 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《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 该实践是骨骼肌和骨组织对长期植入材料反应的短期和长期评估指南。对于最终成品医疗器械的测试，植入的测试品应符合预期用途，包括包装和灭菌。将对供试品的组织反应与对照材料引起的骨骼肌和/或骨组织反应进行比较。 对照组始终显示出已知的细胞反应和伤口愈合。

1.1 This practice provides guidelines for biological assessment of tissue responses to nonabsorbable for medical device implants. It assesses the effects of the material that is implanted intramuscularly or intraosseously. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, or mutagenicity of the material since other standards address these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or skeletal muscle tissue in excess of 30 days. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials are well recognized with a well-characterized long-term response and can include metals and any one of the metal alloys in Specification F67 , F75 , F90 , F136 , F138 , or F562 , high purity dense aluminum oxide as described in Specification F603 , ultra high molecular weight polyethylene as stated in Specification F648 , or USP polyethylene negative control. 1.2 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. 1.3 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. 1.4 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 short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization. The tissue responses to the test article are compared to the skeletal muscle and/or bone tissue response(s) elicited by control materials. The controls consistently demonstrate known cellular reaction and wound healing.