1.1 本规程涵盖了医用塑料的提取方法，并可能适用于其他材料。本规程确定了一种获得“提取液”的方法，用于确定临床前试验中的生物反应。其他ASTM标准规定了“提取液”的进一步测试。作为生物反应临床前评估的一部分，可以对提取物进行化学分析，也可以检查提取后的材料。 1.2 本规程可用于但不限于以下领域:原材料的部分评估、制造过程中的材料审核和最终产品测试。 本规程也可用作测量医疗器械用塑料中可萃取物的参考方法。一般来说，标准用户有责任确定本标准中描述的方法是否适用于其设备中的材料。 1.3 本规程最初用于提取在正常医疗器械使用过程中不会降解或吸收的医用塑料。当用于提取可吸收材料时，在选择提取程序和液体时可能需要额外考虑。 1.4 对于一次性使用系统材料与细胞培养基或用于细胞治疗、疫苗、细胞诊断或其他生物制药产品的制造过程的兼容性评估，用户应参考指南 E3231 . 1.5 以国际单位制表示的数值应视为标准值。括号中给出的值是英寸-磅单位的数学转换，仅供参考，不被视为标准值。 1.6 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。 1.7 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。 ====意义和用途====== 5.1 这些提取程序是医疗器械中使用的塑料或其他材料的生物相容性筛选中使用的几个测试程序的初始部分。 5.2 应认识到从该实践中获得的结果的局限性。萃取剂、浸泡时间和试验温度的选择必然是任意的。这些条件的规范为标准化提供了基础，并为希望比较各种塑料或其他材料对萃取剂的相对阻力的研究人员提供了指南。 5.3 测试结果与材料的实际性能或可用性的相关性必然取决于测试和最终测试之间的相似性- 使用条件（参见 12.1.2 和 附注7 ). 5.4 在理解和意图本实践时应谨慎如下: 5.4.1 未考虑或区分最终用途应用和使用期限等变量。应根据实践决定要进行的测试的选择 F748 . 5.4.2 本规程最初设计用于无孔固体材料。应谨慎考虑其在其他材料中的应用，例如多孔材料、吸收性材料（例如，能够吸收液体的海绵状材料）或吸收性材料。 应考虑改变规定的料液比，以允许额外的液体使材料完全水合，并考虑额外的液体或其他方法使试样完全浸没。还应酌情考虑从试样中完全去除提取液的其他程序，如加压或物理挤压材料。尽管本规程中未给出以下术语的定义，但应考虑规定提取条件下的提取车辆表面张力和试样物理结构等项目。 注1: 虽然目前没有可用的标准化方法来确定吸收装置或材料的溶剂吸收能力，但建议的方案如下: –确定每0.1 g或1.0 cm提取车辆的体积 2. 装置/材料的吸收； –然后，在进行提取时，将该额外体积添加到每0.1 g或1.0 cm中 2. 在萃取混合物中。 5.5 试验方法 D570 和 D1239 和实践 D543 可能有助于提供补充信息。

1.1 This practice covers methods of extraction of medical plastics and may be applicable to other materials. This practice identifies a method for obtaining “extract liquid” for use in determining the biological response in preclinical testing. Further testing of the “extract liquid” is specified in other ASTM standards. The extract may undergo chemical analysis as part of the preclinical evaluation of the biological response, and the material after extraction may also be examined. 1.2 This practice may be used for, but is not limited to, the following areas: partial evaluation of raw materials, auditing materials within the manufacturing process, and testing final products. This practice may also be used as a reference method for the measurement of extractables in plastics used in medical devices. In general, it is the responsibility of the user of the standard to determine if the methods described in this standard are appropriate for the materials in their device. 1.3 This practice was initially developed for extraction of medical plastics not intended to undergo degradation or absorption during normal medical device usage. When applied to the extraction of absorbable materials, additional considerations may be necessary in the selection of extraction procedures and fluids. 1.4 For assessment of compatibility of the Single-use System material with the cell culture medium or the manufacturing processes used for cell-based therapeutics, vaccines, cell-based diagnostics, or other biopharmaceutical products, the user should refer to Guide E3231 . 1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard. 1.6 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. 1.7 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. ====== Significance And Use ====== 5.1 These extraction procedures are the initial part of several test procedures used in the biocompatibility screening of plastics or other materials used in medical devices. 5.2 The limitations of the results obtained from this practice should be recognized. The choices of the extraction vehicle, duration of immersion, and temperature of the test are necessarily arbitrary. The specification of these conditions provides a basis for standardization and serves as a guide to investigators wishing to compare the relative resistance of various plastics or other materials to extraction vehicles. 5.3 Correlation of test results with the actual performance or serviceability of materials is necessarily dependent upon the similarity between the testing and end-use conditions (see 12.1.2 and Note 7 ). 5.4 Caution should be exercised in the understanding and intent of this practice as follows: 5.4.1 No allowance or distinction is made for variables such as end-use application and duration of use. Decisions on selection of tests to be done should be made based on Practice F748 . 5.4.2 This practice was originally designed for use with nonporous, solid materials. Its application for other materials, such as those that are porous, absorptive (for example, sponge-like materials that are capable of absorbing liquid), or resorptive, should be considered with caution. Consideration should be given to altering the specified material-to-liquid ratio to allow additional liquid to fully hydrate the material and additional liquid or other methods to fully submerge the test specimen. Additional procedures that fully remove the extract liquid from the test specimen, such as pressure or physically squeezing the material, should also be considered as appropriate. Although no definitions are given in this practice for the following terms, such items as extraction vehicle surface tension at the specified extraction condition and test specimen physical structure should be taken into account. Note 1: While there are no standardized methods available at present for determining the solvent absorption capacity of an absorptive device or material, a suggested protocol is as follows: – Determine the volume of extraction vehicle that each 0.1 g or 1.0 cm 2 of device/material absorbs; – then, in performing the extraction, add this additional volume to each 0.1 g or 1.0 cm 2 in an extraction mixture. 5.5 Test Methods D570 and D1239 and Practices D543 may be useful in providing supplemental information.