Standard: AAMI 10993-16
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
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This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 10993-16|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|AAMI 10993-16||Change Type: STCH||Update Date: 2010-01-01||Revision: 10||Status: INAC|