Tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve implantates of all types, and of the materials and components of which they are made. Requirements are provided for preclinical, clinical evaluation and for reporting the results.
Status : WithdrawnPublication date : 1996-11
Edition : 3Number of pages : 38
Technical Committee:Cardiovascular implants and extracorporeal systems