1.1 本规范涵盖拟用于外科植入物的未净化聚二氧杂环酮均聚树脂。 1.2 聚二恶烷酮通常缩写为PDO，或者称为聚（对二恶烷酮）或聚（ρ-二恶烷酮），首字母缩写为PPD。此外，它可以被称为PDS，因为它是PDS缝合线组合物的聚合物（Ethicon，Inc.），代表了聚二氧六环酮聚合物的早期和广泛应用。 1.3 本规范涵盖能够在30℃下完全溶剂化的未净化聚二氧杂环酮树脂 °C，通过氟化溶剂，如六氟异丙醇（HFIP）或六氟丙酮（HFA）。 1.4 已知该组合物的均聚物为半结晶。在本规范中，树脂内的半结晶度通过在105和115之间退火时出现DSC（差示扫描量热法）结晶吸热峰来定义 °C。 虽然结晶吸热的存在表明了半结晶性，但结晶相的百分比和形态在很大程度上取决于加工，尤其是材料的热历史。因此，原始聚合物树脂的热性能和结晶度百分比（熔融温度除外）不一定表示最终产品质量。 1.5 本规范阐述了拟用于外科植入物的未净化聚二氧环烷酮基树脂的材料特性，不适用于由这些材料制成的包装和灭菌成品植入物，也不涉及含有复合材料（如染料、聚合物或陶瓷化合物或任何其他添加剂）的聚二氧环烷酮树脂的特性。 1.6 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独立评估这种树脂制成形式的性能，以确保安全性和有效性。 1.7 生物相容性测试不是一项要求，因为本规范无意涵盖制造的设备。虽然树脂的生物相容性测试可能提供潜在安全性的早期指示，但需要对最终成品装置进行生物相容性分析，以确定任何植入装置的安全性和适用性。参考本标准和指南的补充要求S1 F2902 获取相关生物相容性信息。 1.8 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。 1.9 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。 1.10 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 virgin polydioxanone homopolymer resins intended for use in surgical implants. 1.2 Polydioxanone is commonly abbreviated as PDO, and is alternatively referred to as poly(para dioxanone) or poly(ρ-dioxanone) with the acronym PPD. Additionally, it may be referred to as PDS as it is the polymer of composition of PDS suture (Ethicon, Inc.), representing an early and widely used application of polydioxanone polymer. 1.3 This specification covers virgin polydioxanone resins able to be fully solvated at 30 °C by fluorinated solvents such as hexafluoroisopropanol (HFIP) or hexafluoroacetone (HFA). 1.4 Homopolymers of this composition are known to be semi-crystalline. Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm peak upon annealing between 105 and 115 °C. While the presence of a crystalline endotherm indicates semi-crystallinity, the percentage and morphology of the crystalline phase are highly dependent on processing, and in particular on the thermal history of the material. Therefore, the thermal properties and percent crystallinity of the virgin polymer resin (with exception of melting temperature) are not necessarily indicative of final product quality. 1.5 This specification addresses material characteristics of the virgin polydioxanone-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials, nor does it address the characteristics of polydioxanone resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives. 1.6 As with any material, some characteristics may be altered by 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 independently using appropriate test methods to ensure safety and efficacy. 1.7 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. While biocompatibility testing of resin may provide an early indication of potential safety, biocompatibility analysis of the final finished device is required to determine safety and suitability for any implant device. Refer to Supplementary Requirement S1 of this standard and Guide F2902 for relevant biocompatibility information. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.9 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. 1.10 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.