BS EN ISO 10993-17:2009规定了一种测定可从土壤中浸出物质允许限值的方法 医疗设备。它用于推导标准，并在标准不适用的情况下估算适当的限值 不存在。它描述了一个系统化的过程，通过该过程，可以识别有毒有害物质产生的风险 医疗器械中存在的物质可以量化。BS EN ISO 10993-17:2009不适用于没有患者接触的设备（例如体外诊断设备）。接触特定化学物质可能来自设备以外的来源，如食物、水或其他 空气BS EN ISO 10993-17:2009未涉及此类来源的潜在暴露。交叉引用:ISO 10993-1ISO 10993-7ISO 1497193/42/EEC90/385/EECAll购买本文件时提供的当前修订版包括在购买本文件时。

BS EN ISO 10993-17:2009 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.BS EN ISO 10993-17:2009 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. BS EN ISO 10993-17:2009 does not address the potential for exposure from such sources.Cross References:ISO 10993-1ISO 10993-7ISO 1497193/42/EEC90/385/EECAll current amendments available at time of purchase are included with the purchase of this document.