• Size designation of biological and mechanical heart valve prostheses in accordance with the patient annulus
• Differentiation of the annular implantation position (intra-annular, intra-supra-annular, supra-annular)
• Table for the description of the components of a heart valve prosthesis
• Use of compliance chambers for the hydrodynamic testing of prostheses without scaffold
• Determination of the minimum requirement for heart valve prostheses in hydrodynamic tests and specification of reference values with regard to prosthesis-related complications in clinical studies
• Definition of the requirements for clinical long-term studies (patient number, length)
• Introduction of an obligatory post-observation timeframe of 5 years for mechanical heart valves and of 10 years for biological heart valves.