EN 12006-2:1998

EN 12006-2:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits". This standard covers: 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 gives also 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.

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 gives also 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.

EN 12006-2:1998 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 12006-2:1998 has the following relationships with other standards: It is inter standard links to EN 12006-2:1998+A1:2009, EN 12006-2:1998/prA1; is excused to EN 12006-1:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 12006-2:1998 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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