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AAMI 10993-17

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Biological evaluation of medical devices – Part 17: Methods for theestablishment of allowable limits for leachable substances
2002 Edition, 2002
Includes all amendments and changes through Reaffirmation Notice , 2012

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Description

  • Revision:2002 Edition, 2002
  • Published Date:January 2012
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:33
  • ANSI Approved:Yes
  • DoD Adopted:No
  • 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.