EN 12006-2:1998+A1:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Intended performance
5 Design attributes
6 Materials
7 Design evaluation
8 Manufacturing
9 Sterilization
10 Packaging
11 Information supplied by the manufacturer
Annex A (normative) - Classification of prostheses
Annex B (normative) - Bibliography
Annex C (informative) - Reference table EN 12006-2 and
                        ISO/DIS 7198
Annex ZA (informative) - Relationship between this
                         European Standard and the
                         Essential Requirements of
                         EU Directive 93/42/EEC

This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.This European Standard is not applicable to prostheses derived from host tissue (autografts).NOTEA valve conduit is regarded as a composite prosthesis and falls within the scope of this standard.With regard to safety it gives in addition to EN ISO 14630:1997, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.This European Standard specifies the designation of materials of the manufacturer and the construction of the device, and the designation of sizes and dimensions of vascular prostheses. It specifies biological requirements for the materials of construction and for the finished product by references to appropriate International and European Standards.In addition this European Standard specifies the designation of mechanical properties. It describes methods for the measurement and verification of the dimensions and mechanical properties stated by the manufacturer, including durability testing.This standard also gives requirements for packaging and labelling. It provides definitions of the terms in common use.This European Standard does not specify all possible performance or dimensional characteristics. In such cases, the European Standard does however include methods to verify the nominal values stated by the manufacturer.