Standard: AAMI 10993-17

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: METHODS FOR THE ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES

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Scope:

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.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 10993-17
Publish Date: 2002-01-01
Page Count: 33
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: YES
Status: Active

Document History

Document # Change Type Update Date Revision Status
AAMI 10993-17 Change Type: REAF Update Date: 2002-01-01 Revision: 02 Status: ACTV
AAMI 10993-17 Change Type: Update Date: 2002-01-01 Revision: 02 Status: ACTV

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