This part of ISO 10993 specifies the method for thedetermination of allowable limits for substances leachable frommedical devices. It is intended for use in deriving standards andestimating appropriate limits where standards do not exist. Itdescribes a systematic process through which identified risksarising from toxicologically hazardous substances present inmedical devices can be quantified.
This part of ISO 10993 is not applicable to devices that have nopatient contact (e.g., in vitro diagnostic devices).
Exposure to a particular chemical substance may arise from othersources other than the device, such as food, water, or air. Thispart of ISO 10993 does not address the potential for exposure fromsuch sources.