ISO 10993-17:2002 医疗设备生物评定-第17部分：可滤取物质允许界限的制定

标准编号：ISO 10993-17:2002

中文名称：医疗设备生物评定-第17部分：可滤取物质允许界限的制定

英文名称：Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

发布日期：2002-12

标准范围

ISO 10993-17:2002规定了医疗器械中可浸出物质的允许限值的测定。它用于推导标准和估算不存在标准的适当限值。它描述了一个系统化的过程，通过该过程，可以量化医疗器械中有毒有害物质产生的风险。ISO 10993-17:2002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、水或空气。ISO 10993-17:2002未涉及此类来源的潜在暴露。

ISO 10993-17:2002 specifies 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.ISO 10993-17:2002 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. ISO 10993-17:2002 does not address the potential for exposure from such sources.

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