EN 12006-1:1999

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 1: Heart valve substitutes

Publication date:   Mar 19, 2004

Scope

This standard specifies particular requirements for heart valve substitutes. This European Standard is not applicable to heart valve substitutes composed in whole, or in part, of human tissue. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. This European Standard specifies a number of test methods and requirements regarding the performance characteristics of equipment to be used to determine the physical, biological and chemical properties of heart valve substitutes and of the materials and components of which they are made. Recommendations are also made for in vivo testing and clinical evaluation, and for the reporting of results of all types of testing and evaluation covered in this European Standard. These recommendations do not purport to comprise a complete test programme (see annex F for rationale).

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