ISO 5840-3 2013 Edition, “Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques,” has just been released. Available now from Document Center, the standard 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.
This new ISO 5840-3 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
ISO 5840-3 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute.
It can be used for both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labeling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
FYI: There are two additional parts that are in process:
- ISO 5840-1, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements, and
- ISO 5840-2, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted valve substitutes
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