1.1 本规范涵盖了聚碳酸酯树脂，并提供了该热塑性塑料用于制造医疗器械或医疗器械组件时的要求和相关测试方法。 1.2 与任何材料一样，某些特性可能会因生产特定零件或装置所需的加工技术（如成型、挤压、机加工、组装、灭菌等）而改变。因此，应使用适当的测试方法来评估这种树脂的制造形式的性能，以确保安全性和有效性。 1.3 本规范中包含的性能仅适用于聚碳酸酯。 不应假设由含有着色剂、填料、加工助剂或其他添加剂的聚碳酸酯树脂以及含有聚碳酸酯的聚合物混合物组成的塑料化合物的生物相容性。这些改性聚碳酸酯的生物相容性必须通过使用适当的评估方法测试最终（最终用途）成分来确定。此外，材料的生物相容性在很大程度上取决于最终用途的性质。因此，有必要为每个新的和不同的应用指定一套生物相容性测试方法。 1.4 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。 1.5 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 polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices. 1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy. 1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application. 1.4 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. 1.5 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.