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  3. AAMI/ISO TIR15499:2017 PDF

AAMI/ISO TIR15499:2017 PDF

AAMI/ISO TIR15499:2017 PDF

Name:
AAMI/ISO TIR15499:2017 PDF

Published Date:
08/27/2017

Status:
Active

Description:

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

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 Russian version):
200 business days
SKU:
Choose Document Language:
$53.4
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This guidance is applicable to the conduct of biological evaluation of medical devices according to the requirements of ISO 10993-1. It does not add to, or otherwise change, the requirements of ISO 10993-1. This guidance does not include requirements to be used as the basis of regulatory inspection or certification assessment activities. This guidance is applicable to all biological evaluation of all types of medical devices including active, non-active, implantable and nonimplantable medical devices.
ANSI : ANSI Approved
File Size : 1 file , 310 KB
ISBN(s) : 9781570206863
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 26
Published : 08/27/2017
Same As : AAMI/ISO TIR15499:2017

History

AAMI/ISO TIR15499:2017
AAMI/ISO TIR15499:2017
Published Date: 08/27/2017
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
$53.4
AAMI/ISO TIR15499:2012
AAMI/ISO TIR15499:2012
Published Date: 12/03/2012
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
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