-
-
Available Formats
- Options
- Availability
- Priced From ( in USD )
-
Available Formats
-
- Immediate download
- $250.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $250.00
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- $391.00
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 14602:2010
Priced From $124.00 -
ISO 10328-2:1996
Priced From $48.00 -
ISO 8548-5:2003
Priced From $54.00 -
ISO 7197:2024
Priced From $81.00
About This Item
Full Description
ISO 5840-3:2021 is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
This document establishes 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 can 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.
This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
Document History
-
ISO 5840-3:2021 Plus Redline
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques- Historical Version
-
ISO 5840-3:2021
viewing
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques- Most Recent
-
ISO 5840-3:2013
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques- Historical Version