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ISO 5840-2 1st Edition, September 15, 2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
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Availability date: 07/13/2021
Description / Abstract:
This part of ISO 5840 is applicable to heart valve substitutes
intended for implantation in human hearts, generally requiring
cardiopulmonary bypass and generally with direct visualization.
This part of ISO 5840 is applicable to both newly developed and
modified surgical heart valve substitutes and to the accessories,
packaging, and labelling required for their implantation and for
determining the appropriate size of the surgical heart valve
substitute to be implanted.
This part of ISO 5840 outlines an approach for qualifying the
design and manufacture of a surgical heart valve substitute through
risk management. The selection of appropriate qualification tests
and methods are derived from the risk assessment. The tests may
include those to assess the physical, chemical, biological, and
mechanical properties of surgical heart valve substitutes and of
their materials and components. The tests may also include those
for pre-clinical in vivo evaluation and clinical evaluation of the
finished surgical heart valve substitute.
This part of ISO 5840 defines performance requirements for
surgical heart valve substitutes where adequate scientific and/or
clinical evidence exists for their justification.
For novel surgical heart valve substitutes, e.g. sutureless, the
requirements of both this International Standard and ISO 5840-3
might be relevant and shall be considered as applicable to the
specific device design and shall be based on the results of the
risk analysis.
This part of ISO 5840 excludes heart valve substitutes designed
for implantation in artificial hearts or heart assist devices.
This part of ISO 5840 excludes homografts.