Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by minimally invasive techniques (ISO/DIS 5840-3:2011); German version prEN ISO 5840-3:2011
Project begin
2008-05-15
WI
00285089
Planned document number
DIN EN ISO 5840-3
Abstract
This International Standard specifies requirements for all devices intended for implantation in human hearts as a minimally invasive implanted heart valve substitute.
This International Standard is applicable to both newly developed and modified minimally invasive implanted 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.
It outlines an approach for qualifying the design and manufacture of a minimally invasive heart valve substitute through risk management. The selection of appropriate qualification 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 may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This International Standard imposes design specifications and minimum performance specifications for minimally invasive implanted heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This International Standard is not applicable to heart valve substitutes designed for implantation in artificial hearts or heart assist devices and does not specifically address requirements for valve-in-valve configurations.
Responsible Committee
NA 027-02-17-01 UA Cardiovascular implants
Draft standard
Search in NA 027
Contact
Dipl.-Ing.
Karl Wenzelewski
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