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AAMI 10993-17
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AAMI 10993-17 2002 Edition, January 1, 2002 Biological evaluation of medical devices - Part 17: Methods for the establishment of allowable limits for leachable substances
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Description / Abstract:
This part of ISO 10993 specifies the 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 other 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.
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 other 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.