1.1 本规范涵盖了短切碳纤维增强（CFR）聚醚醚酮（PEEK）聚合物的颗粒、用于添加剂制造的长丝或制造形式。当这些热塑性复合材料用于制造体内装置（如外科植入物或外科或牙科装置的部件）时，本标准提供了这些热塑性复合材料的要求和相关测试方法。 1.2 本规范中包含的特性仅适用于短切CFR-PEEK化合物和制造形式。本规范不包括含有着色剂、填料（碳纤维除外）、加工助剂或其他添加剂的材料或形式，以及含有聚醚醚酮的聚合物混合物或再生材料。 1.2.1 本标准不包括连续碳纤维增强聚醚醚酮复合材料，其使用与短切CFR-PEEK不同的工艺制造。 1.2.2 本标准可包括使用偶联剂（施胶剂）制造的CFR-PEEK化合物。然而，当使用偶联剂改善碳纤维的润湿性时，生物风险评估和生物相容性测试应考虑这些偶联剂。 1.3 本规范旨在推荐物理、化学和生物测试方法，以建立医疗植入装置中使用的CFR-PEEK聚合物性能的合理置信度。 1.4 以国际单位制表示的数值应视为标准值。 本标准不包括其他计量单位。 1.5 根据本规范评估材料时，可能涉及危险材料、操作和设备。 1.6 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。 1.7 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。

1.1 This specification covers chopped carbon-fiber reinforced (CFR) polyetheretherketone (PEEK) polymer in pellets, filaments used in additive manufacturing, or fabricated forms. It provides requirements and associated test methods for these thermoplastic composites when they are to be used in the manufacture of intracorporeal devices such as surgical implants or components of surgical or dental devices. 1.2 The properties included in this specification are those applicable for chopped CFR-PEEK compounds and fabricated forms only. Materials or forms containing colorants, fillers other than carbon fibers, processing aids, or other additives, as well as polymer blends which contain PEEK, or reclaimed materials, are not covered by this specification. 1.2.1 This standard does not include continuous carbon-fiber reinforced PEEK composites, which are fabricated using a different process than chopped CFR-PEEK. 1.2.2 This standard can include CFR-PEEK compounds that are fabricated with the use of coupling (sizing) agents. However, when coupling agents are used to improve wetting of the carbon fibers, the biological risk assessments and biocompatibility testing should consider these coupling agents. 1.3 This specification is designed to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence concerning the performance of CFR-PEEK polymers for use in medical implant devices. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.5 When evaluating material in accordance with this specification, hazardous materials, operations, and equipment may be involved. 1.6 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. 1.7 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.