AAMI/ISO TIR15499:2012 Historical

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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 12/03/2012

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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. See more

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  1. AAMI/ISO TIR15499:2017


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

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Product Details

Published:

12/03/2012

ISBN(s):

1570204748

ANSI:

ANSI Approved

Number of Pages:

30

File Size:

1 file

Same As:

ISO/TR 15499:2012

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus