1.1 本规范涵盖未经处理的半结晶聚乙烯( l -丙交酯）或聚( d -用于外科植入物的丙交酯均聚树脂。本规范还涵盖以下材料的半结晶树脂: l -丙交酯与其他生物可吸收单体共聚，包括但不限于乙交酯， d -丙交酯，和 dl -丙交酯。多边形( l -丙交酯）或聚( d -本规范涵盖的丙交酯基均聚物和共聚物具有足够长度的丙交酯段，允许其在退火时结晶。 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。在基于乳酸的首字母缩略词中包含立体异构体特异性，结果如下:( l -丙交酯） l LA代表poly( l -乳酸），聚( d -丙交酯） d LA代表poly( d -乳酸）和聚乳酸( dl -丙交酯） dl LA代表poly( dl -乳酸）。 1.3 本规范适用于丙交酯基聚合物或共聚物，其具有尺寸足以承载丙交酯基结晶潜力的等规聚合物段。此类聚合物通常具有等于或超过50的标称摩尔分数 % l -丙交酯。本规范特别适用于基于等规丙交酯的嵌段共聚物或由以下物质的组合合成的聚合物或共聚物: d -丙交酯和 l -差异超过1.5总摩尔百分比（1.5%）的丙交酯 % 总摩尔数）。本规范不适用于乙交酯摩尔分数大于或等于70的丙交酯-乙交酯共聚物 % (65. 3. % 以质量分数表示），其包含在规范中 F2313 . 本规范不适用于由以下物质的组合合成的非晶态聚合物或共聚物: d -丙交酯和 l -差异小于1.5总摩尔百分比（1.5%）的丙交酯 % 总摩尔数），如规范所述 F2579 . 1.4 本规范涵盖了能够在30℃完全溶剂化的纯半结晶聚丙交酯基树脂 °C，通过二氯甲烷（二氯甲烷）或氯仿（三氯甲烷）。本规范不适用于丙交酯:乙交酯共聚物，其乙交酯段大小足以提供乙交酯的潜力- 基于结晶，因此需要氟化溶剂在室温条件下完全溶解（见规范 F2313 ). 1.5 在本规范中，树脂内的半结晶度通过在玻璃化转变温度以上退火后存在DSC（差示扫描量热法）结晶吸热来定义。虽然其他共聚物段也可能在退火后结晶（例如乙交酯），但除丙交酯形成的结晶结构外，结晶结构的具体表征不在本规范的范围内。 1.6 本规范阐述了原始半成品的材料特性- 用于外科植入物的结晶聚丙交酯基树脂，不适用于由这些材料制成的包装和灭菌成品植入物。 1.7 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。 1.8 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。 1.9 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。 1.10 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。 1.11 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 semi-crystalline poly( l -lactide) or poly( d -lactide) homopolymer resins intended for use in surgical implants. This specification also covers semi-crystalline resins of l -lactide copolymerized with other bioabsorbable monomers including, but not limited to, glycolide, d -lactide, and dl -lactide. The poly( l -lactide) or poly( d -lactide) based homopolymers and copolymers covered by this specification possess lactide segments of sufficient length to allow potential for their crystallization upon annealing. 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. Inclusion of stereoisomeric specificity within the lactic acid based acronyms results in the following: poly( l -lactide) as P l LA for poly( l -lactic acid), poly( d -lactide) as P d LA for poly( d -lactic acid), and poly( dl -lactide) as P dl LA for poly( dl -lactic acid). 1.3 This specification is applicable to lactide-based polymers or copolymers that possess isotactic polymeric segments sufficient in size to carry potential for lactide-based crystallization. Such polymers typically possess nominal mole fractions that equal or exceed 50 % l -lactide. This specification is particularly applicable to isotactic-lactide based block copolymers or to polymers or copolymers synthesized from combinations of d -lactide and l -lactide that differ by more than 1.5 total mole percent (1.5 % of total moles). This specification is not applicable to lactide-co-glycolide copolymers with glycolide mole fractions greater than or equal to 70 % (65.3 % in mass fraction), which are covered by Specification F2313 . This specification is not applicable to amorphous polymers or copolymers synthesized from combinations of d -lactide and l -lactide that differ by less than 1.5 total mole percent (1.5 % of total moles) as covered by Specification F2579 . 1.4 This specification covers virgin semi-crystalline poly(lactide)-based resins able to be fully solvated at 30 °C by either methylene chloride (dichloromethane) or chloroform (trichloromethane). This specification is not applicable to lactide: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 (see Specification F2313 ). 1.5 Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm after annealing above the glass transition temperature. While other copolymeric segments may also crystallize upon annealing (for example, glycolide), specific characterization of crystalline structures other than those formed by lactide are outside the scope of this specification. 1.6 This specification addresses material characteristics of the virgin semi-crystalline poly(lactide)-based resins intended for use in surgical implants and does not apply to packaged and sterilized finished implants fabricated from these materials. 1.7 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. 1.8 Biocompatibility testing is not a requirement since this specification is not intended to cover fabricated devices. 1.9 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.10 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. 1.11 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.