1.1 本试验方法涵盖了用水性或有机溶剂萃取时从金属、聚合物和陶瓷医用组分中获得的残留物量的定量评估。 1.2 本试验方法不提倡可接受的洁净度水平。它确定了两种可能的技术来量化金属、聚合物和陶瓷医疗部件上的可提取残留物。此外，应认识到，该检测方法可能不是测定和定量浸提物的唯一方法。如果经过验证以确保所需的提取效率，也可以使用被认为对表面残留物穷尽的其他提取技术。 1.3 尽管这些方法可以为研究者提供一种比较组分清洁度相对水平的方法，但应认识到，这些方法可能无法解释某些形式的组分残留物。1.4 这些通用重量法的适用性已被许多文献报道所证明；然而，应通过验证或研究证明特定医疗成分的适用性。见 附录X2 . 1.5 本试验方法不用于评价已清洗以供重复使用的医疗部件中的残留水平。该试验方法也不旨在提取残留物用于生物相容性试验，即不旨在满足ISO 10993-18对浸提物和浸出物的要求。此外，本文件不适用于以下医疗器械: 1.5.1 设备（例如，消毒器和洗衣机/洗衣机消毒器）。 1.5.2 气路装置。 1.5.3 液态或气态医疗器械。 1.5.4 许多可吸收医疗装置，例如水凝胶或天然存在的衍生材料，例如胶原、甲壳素/壳聚糖、海藻酸、透明质酸等。这将与所使用的提取不相容，而一些可吸收医疗装置可能与该方法相容。 1.5.5 软件。 1.5.6 如果存在针对特定设备的其他垂直标准，则将使用这些标准作为本标准的补充或替代。 附注1: 对于拟用于器械或材料生物学评价的供试品的提取，请参见ISO 10993-12。 1.6 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。 1.7 本标准可能涉及危险或环境限制的材料、操作和设备。 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。1.8 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》中确立的国际公认的标准化原则制定的。 ======意义和用途====== 5.1 本试验方法适用于测定金属、聚合物和陶瓷医用部件上可萃取残留物的总量。可萃取残留物包括水性和非水性残留物，以及不溶性残留物。 5.2 本试验方法推荐使用超声处理技术或溶剂回流技术（索氏）从医疗成分中提取残留物。可以使用其他技术，如振动筛/尖端台，但在一些测试中已显示效率较低，如中所讨论的 X1.2 . 5.3 本试验方法不适用于评价重复使用一次性组件（SUD）的可提取残留物。

1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic, polymeric, and ceramic medical components when extracted with aqueous or organic solvents. 1.2 This test method does not advocate an acceptable level of cleanliness. It identifies two possible techniques to quantify extractable residue on metallic, polymeric, and ceramic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. Other extraction techniques that are considered exhaustive for surface residuals could also be used if validated to ensure the required extraction efficiency. 1.3 Although these methods may give the investigator a means to compare the relative levels of component cleanliness, it is recognized that some forms of component residue may not be accounted for by these methods. 1.4 The applicability of these general gravimetric methods have been demonstrated by many literature reports; however, the suitability for a specific medical component should be demonstrated by validation or study. See Appendix X2 . 1.5 This test method is not intended to evaluate the residue level in medical components that have been cleaned for reuse. This test method is also not intended to extract residue for use in biocompatibility testing, that is, does not intend to satisfy the extractables and leachables requirement of ISO 10993-18. In addition, this document does not apply to the following medical devices: 1.5.1 Equipment (for example, sterilizers and washers/washer-disinfectors). 1.5.2 Gas path devices. 1.5.3 Liquid or gaseous medical devices. 1.5.4 Many absorbable medical devices such as hydrogels or naturally occurring derived materials such as collagen, chitin/chitosan, alginic acid, hyaluronic acid, etc. that will be incompatible with the extractions utilized while some absorbable medical devices may be compatible with the method. 1.5.5 Software. 1.5.6 Where other vertical standards exist for specific devices, they will be used in addition to or instead of this standard. Note 1: For extraction of test specimens intended for the biological evaluation of devices or materials, refer to ISO 10993-12. 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 may involve hazardous or environmentally restricted materials, operations, and equipment. 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. ====== Significance And Use ====== 5.1 This test method is suitable for determination of the total amount of extractable residue on metallic, polymeric, and ceramic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as insoluble residue. 5.2 This test method recommends the use of either a sonication technique or a solvent reflux technique (Soxhlet) to extract residue from the medical component. Other techniques such as shaker/tip tables could be used but have been shown to be less efficient in some tests, as discussed in X1.2 . 5.3 This test method is not applicable for evaluating the extractable residue for the reuse of a single-use component (SUD).