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ISO 5840-1 1st Edition, September 15, 2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
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Description / Abstract:
This part of ISO 5840 is applicable to heart valve substitutes
intended for human implantation and provides general requirements.
Subsequent parts of the ISO 5840–series provide specific
requirements.
This part of ISO 5840 is applicable to both newly developed and
modified heart valve substitutes and to the accessories, packaging,
and labelling required for their implantation and for determining
the appropriate size of the heart valve substitute to be
implanted.
This part of ISO 5840 outlines an approach for qualifying the
design and manufacture of a 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 heart valve substitutes and of their materials and
components.
The tests may also include those for preclinical in vivo
evaluation and clinical evaluation of the finished heart valve
substitute.
This part of ISO 5840 defines operational conditions for heart
valve substitutes. This part of ISO 5840 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is
given in Annex A.