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Update of the European standards for inactive surgical implants in the area of heart valve prostheses

^a Clinic for Thoracic and Cardiovascular Surgery, German Heart Center Munich, Lazarettstrasse 36, D-80636 Munich, Germany
^b Department of Cardiac Surgery, University Hospital Grosshadern, Marchioninistrasse 15, D-81377 Munich, Germany

Received 11 April 2007; received in revised form 10 August 2007; accepted 15 August 2007.

^_* Corresponding author. Address: German Heart Center Munich, Department of Cardiovascular Surgery, Lazarettstrasse 36, D-80636 Munich, Germany. Tel.: +49 89 1218 4020; fax: +49 89 1218 4093. (Email: eichinger{at}dhm.mhn.de).

Objective: The approval of a heart valve for the European market takes place in accordance with European and international standards. A new version of the EN Standards was published in June 2006, which responded to different technical innovations in the area of heart valve technology. This work outlines the differences between the new EN ISO 5840 (2005) and the old EN 12006-1 (1999). Methods: We compared the ‘new’ EN ISO 5840 (2005) and the ‘old’ EN 12006-1 (1999). Results: The following aspects have been updated in the new EN ISO 5840:

• 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.

Abbreviations: °C = degree celsius • CEN = European Committee for Standardization • CO = cardiac output • e.g. = example given • EN = European norm • EOA = effective orifice area • ESRD = external sewing ring diameter • EU = European Union • FDA = Food and Drug Administration • IOA = internal orifice area • ISO = International Standardization Organization • kPa = kilo Pascal • min = minute • ml = milliliter • mmHg = millimeter of mercury • TAD = tissue annulus diameter • TC = Technical Committee • TÜV = Technical Inspection Association

Key Words: Heart valve prosthesis • Norm • EN • ISO