DIN EN 12006-2-2009 非活性外科植入物.心脏和血管植入物的详细要求.第2部分:包括心脏瓣膜导管的血管修补物(包括修改件A1-2009).英文版本DIN EN 12006-2-2009-08
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits (includes Amendment A1:2009) ; English version of DIN EN 12006-2:2009-08
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).
NOTE A 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.