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  3. AAMI/ISO 5840-3:2013 PDF

AAMI/ISO 5840-3:2013 PDF

AAMI/ISO 5840-3:2013 PDF

Name:
AAMI/ISO 5840-3:2013 PDF

Published Date:
12/04/2012

Status:
Active

Description:

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

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:
$95.7
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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.
ANSI : ANSI Approved
File Size : 1 file , 1.2 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 128
Published : 12/04/2012
Same As : AAMI/ISO 5840-3:2013

History

AAMI/ISO 5840-3:2022
AAMI/ISO 5840-3:2022
Published Date: 12/13/2021
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
$87.9
AAMI/ISO 5840-3:2013
AAMI/ISO 5840-3:2013
Published Date: 12/04/2012
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
$95.7

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