BS EN ISO 5840-2:2015 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.


Cross References:
ISO 5840-1:2015
ISO 10993-1
ISO 10993-2
ISO 14155
ISO 14630
ISO 14971
ISO 16061
ISO/IEC 17025:2005
ISO 22442
ASTM F2052
ASTM F2119
ASTM F2182
ASTM F2213
ASTM F2503
ISO 532:1975
ISO 8601
ISO 11135
ISO 11137
ISO/TS 11139:2006
ISO 11607
ISO/TS 12417:2011
ISO 13485
ISO 14160
ISO 14937
ISO 17665-1:2006
ISO 25539-1:2003
IEC 62366
IEC 60651


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