1.1 本试验方法涵盖了用水或有机溶剂萃取时从金属医疗成分中获得的残留量的定量评估。 1.2 本试验方法不提倡可接受的清洁度水平。它确定了两种量化金属医疗成分上可提取残留物的技术。此外，人们认识到，该试验方法可能不是确定和量化可提取物的唯一方法。 1.3 虽然这些方法可以为研究者提供一种比较成分清洁度相对水平的方法，但人们认识到，这些方法可能无法解释某些形式的成分残留。 1.4 许多文献报道证明了这些一般重量分析方法的适用性； 然而，根据实践进行的实验室间研究（ILS）将验证应用于所有金属医疗组件的具体适用性 E691 . 1.5 本试验方法不用于评估已清洁以供再次使用的医疗组件中的残留水平。本试验方法也无意提取用于生物相容性试验的残留物。 注1: 对于用于装置或材料生物评估的样品提取，请参阅ISO 10993-12。 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 本标准可能涉及危险或环境受限的材料、操作和设备。 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。 ====意义和用途====== 5.1 本试验方法适用于测定金属医疗成分中可提取残留物的总量。可提取残渣包括水性和非水性残渣以及不溶性残渣。 5.2 本试验方法建议使用超声波技术从医用成分中提取残留物。可以使用其他技术，如溶剂回流萃取，但在一些试验中已证明效率较低，如中所述 X1.2 . 5.3 本试验方法不适用于评估一次性使用成分（SUD）再利用的可提取残留物。

1.1 This test method covers the quantitative assessment of the amount of residue obtained from metallic 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 techniques to quantify extractable residue on metallic medical components. In addition, it is recognized that this test method may not be the only method to determine and quantify extractables. 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 specific suitability for applications to all-metal medical components will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691 . 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. Note 1: For extraction of samples 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 in metallic medical components. Extractable residue includes aqueous and non-aqueous residue, as well as non-soluble residue. 5.2 This test method recommends the use of a sonication technique to extract residue from the medical component. Other techniques, such as solvent reflux extraction, 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).