1.1 本规范涵盖拟用于外科植入物的纯聚（乙交酯）均聚物和聚（乙交酯-丙交酯）共聚物树脂。本规范涵盖的聚（乙交酯-氯交酯）共聚物的标称摩尔分数大于或等于乙交酯的70%（质量分数为65.3%）。本规范还适用于丙交酯-共乙交酯共聚物，其乙交酯段的大小足以提供乙交酯结晶的可能性，因此需要氟化溶剂在室温条件下完全溶解。 1.2 由于聚（乙交酯）通常缩写为聚（乙醇酸）的PGA，聚（丙交酯）通常缩写为聚（乳酸）的PLA，因此这些聚合物通常称为PGA、PLA和PLA: 分别降解为水解副产物的PGA树脂。PLA是一个不具有立体异构特异性的术语，因此包括无定形无规/间规 dl -丙交酯基聚合物和共聚物以及等规共聚物 d -PLA和 l -PLA部分，每个部分都具有结晶潜力。 1.3 本规范特别不适用于非晶态聚（丙交酯-乙交酯）或聚（丙交酯）基树脂，其能够在30°C下通过二氯甲烷（二氯甲烷）或三氯甲烷（三氯甲烷）完全溶剂化，其在规范中涵盖 F2579 通常具有约50摩尔乙交酯水平 % 或更少。本规范不适用于丙交酯- 具有尺寸足以承载基于丙交酯结晶潜力的等规聚合物段的聚合物或共聚物，其包含在规范中 F1925 并且通常具有等于或超过50的标称摩尔分数 % l -丙交酯。 1.4 本规范涉及未经处理的聚（乙交酯）和聚（>70）的材料特性 % 乙交酯-丙交酯）树脂用于外科植入物，不适用于由这些材料制成的包装和灭菌成品植入物。 1.5 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。 1.6 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。 1.7 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。 1.8 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 both virgin poly(glycolide) homopolymer and poly(glycolide-co-lactide) copolymer resins intended for use in surgical implants. The poly(glycolide-colactide) copolymers covered by this specification possess nominal mole fractions greater than or equal to 70 % glycolide (65.3 % in mass fraction). This specification is also applicable to lactide-co-glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide-based crystallization, thereby requiring fluorinated solvents for complete dissolution under room temperature conditions. 1.2 Since poly(glycolide) is commonly abbreviated as PGA for poly(glycolic acid) and poly(lactide) is commonly abbreviated as PLA for poly(lactic acid), these polymers are commonly referred to as PGA, PLA, and PLA:PGA resins for the hydrolytic byproducts to which they respectively degrade. PLA is a term that carries no stereoisomeric specificity and therefore encompasses both the amorphous atactic/syndiotactic dl -lactide-based polymers and copolymers as well as the isotactic d -PLA and l -PLA moieties, each of which carries potential for crystallization. 1.3 This specification is specifically not applicable to amorphous poly(lactide-co-glycolide) or poly(lactide)-based resins able to be fully solvated at 30°C by either methylene chloride (dichloromethane) or chloroform (trichloromethane), which are covered in Specification F2579 and typically possess molar glycolide levels of ~50 % or less. This specification is not applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization, which are covered by Specification F1925 and typically possess nominal mole fractions that equal or exceed 50 % l -lactide. 1.4 This specification addresses material characteristics of both virgin poly(glycolide) and poly(>70 % glycolide-co-lactide) resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. 1.5 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 assure safety and efficacy. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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. 1.8 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.