DIN EN ISO 10993-17-2009 医疗器械的生物学评定.第17部分:可浸出物质容许限值的确定(ISO 10993-17-2002);德文版本EN ISO 10993-17-2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); English version of DIN EN ISO 10993-17:2009-08
This part of ISO 10993 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.
This part of ISO 10993 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. This part of ISO 10993 does not address the potential for exposure from such sources.