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

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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 , 450 KB
ISBN(s) :	1570204748
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	30
Published :	12/03/2012
Same As :	AAMI/ISO TIR15499:2012

AAMI/ISO TIR15499:2012 PDF

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

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