1.1 本规范涵盖原始半结晶聚（ l -丙交酯）或聚（ d -丙交酯)均聚物树脂，用于外科植入物。本说明书还涵盖以下的半结晶树脂: l -与其他生物可吸收单体共聚的丙交酯，包括但不限于乙交酯， d -丙交酯，和 dl -丙交酯。保利（ l -丙交酯）或聚（ d 本说明书涵盖的基于丙交酯的均聚物和共聚物具有足够长度的丙交酯链段以允许它们在退火时结晶的可能性。 1.2 由于聚(乙交酯)通常缩写为聚(乙醇酸)的PGA，并且聚(丙交酯)通常缩写为聚(乳酸)的PLA，因此对于它们各自降解成的水解副产物，这些聚合物通常被称为PGA、PLA和PLA: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立构/间同立构 dl -丙交酯基聚合物和共聚物以及全同立构 d -解放军和 l -PLA部分，其各自具有结晶潜力。在基于乳酸的首字母缩略词中包含立体异构特异性导致以下结果: l -丙交酯）作为P l LA for poly（ l -乳酸）、聚（ d -丙交酯）作为P d LA for poly（ d -乳酸）和聚（ dl -丙交酯）作为P dl LA for poly（ dl -乳酸)。 1.3 本说明书适用于具有尺寸足以承载丙交酯基结晶潜力的全同立构聚合物链段的基于丙交酯的聚合物或共聚物。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。本说明书特别适用于基于全同立构-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 -总摩尔百分比相差超过1.5(总摩尔的1.5%)的丙交酯。 1.4 本说明书涵盖能够在30℃下被二氯甲烷(二氯甲烷)或氯仿(三氯甲烷)完全溶剂化的原始半结晶聚(丙交酯)基树脂。 1.5 本说明书不适用于丙交酯:乙交酯共聚物，其具有足够大小的乙交酯链段以提供基于乙交酯的结晶的潜力，需要氟化溶剂才能在室温条件下完全溶解（参见说明书 F2313 ). 1.6 本规范不适用于丙交酯-质量标准涵盖的乙交酯摩尔分数大于或等于70%（质量分数为65.3%）的共乙交酯共聚物 F2313 本说明书不适用于由以下物质的组合合成的无定形聚合物或共聚物: d -丙交酯和 l -质量标准所涵盖的总摩尔百分比（总摩尔的1.5%）相差小于1.5的丙交酯 F2579 . 1.7 在本说明书中，树脂内的半结晶度通过DSC(差示扫描量热法)结晶吸热(熔融)的存在来定义。结晶吸热的存在指示半结晶性。结晶相的百分比和形态高度依赖于加工，特别是取决于材料的热历史。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)不一定指示最终产品质量或结晶度。虽然其它共聚物链段也可以在退火时结晶(例如乙交酯)，但是除了由丙交酯形成的晶体结构之外的晶体结构的具体表征超出了本说明书的范围。树脂在“聚合时”可以是半结晶的，但在成品形式中是无定形的。 1.8 本说明书涉及用于外科植入物的原始半结晶聚(丙交酯)基树脂的材料特性，并且不适用于由这些材料制造的包装和灭菌的成品植入物，也不涉及与诸如染料、聚合物或陶瓷化合物或任何其他添加剂的复合材料的树脂的特性。 1.9 与任何材料一样，一些特性可以通过生产特定部件或装置所需的加工技术(诸如模制、挤出、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该树脂的制造形式的性能，以确保安全性和有效性。 1.10 生物相容性试验不是一项要求，因为本质量标准不涵盖制造器械。虽然树脂的生物相容性测试可以提供潜在安全性的早期指示，但需要对最终成品器械进行生物相容性分析，以确定任何植入器械的安全性和适用性。参见本标准和指南的补充要求S1 F2902 相关生物相容性信息。 1.11 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.12 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.13 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》中确立的国际公认的标准化原则制定的。

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). 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). 1.5 This specification is not applicable to lactide:glycolide copolymers that possess glycolide segments sufficient in size to deliver potential for glycolide-based crystallization, requiring fluorinated solvents for complete dissolution under room temperature conditions (see Specification F2313 ). 1.6 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 . 1.7 Within this specification, semi-crystallinity within the resin is defined by the presence of a DSC (differential scanning calorimetry) crystalline endotherm (melting). 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 exeption of melting temperature) are not necessarily indicative of final product quality or crystallinity. 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. A resin may be semi-crystalline “as polymerized” but amorphous in a finished product form. 1.8 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, nor does it address the characteristics of resins with compounded materials such as dyes, polymeric or ceramic compounds, or any other additives. 1.9 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. 1.10 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. 1.11 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.12 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. 1.13 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.