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  3. AAMI/ISO 10993-16:1997 (R2009) PDF

AAMI/ISO 10993-16:1997 (R2009) PDF

AAMI/ISO 10993-16:1997 (R2009) PDF

Name:
AAMI/ISO 10993-16:1997 (R2009) PDF

Published Date:
08/04/1997

Status:
Active

Description:

Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Czech version):
200 business days
SKU:
aami-iso-10993-16-1997-r2009_1087282
Choose Document Language:
23.10
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This standard 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.
ANSI : ANSI Approved
File Size : 1 file , 260 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 19
Published : 08/04/1997

History

AAMI/ISO 10993-16:2020/(R)2022
AAMI/ISO 10993-16:2020/(R)2022
Published Date: 11/06/2020
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
47.10 €
AAMI/ISO 10993-16:2010/(R)2014
AAMI/ISO 10993-16:2010/(R)2014
Published Date: 02/09/2010
Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables
AAMI/ISO 10993-16:1997 (R2009)
AAMI/ISO 10993-16:1997 (R2009)
Published Date: 08/04/1997
Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices
23.10 €

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