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ANSI/AAMI/ISO 5840-3:2013

Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques.

Summary:
Outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

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Product Code:
584003-PDF
Date:
December 04, 2012
ISBN Number:
1-57020-492-6
Media:
PDF
Pages:
116
Available for Immediate Download
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Currently Selected: PDF
AAMI Member:
$155.00
List Price:
$274.00
Your Price:
$274.00
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