EN 12006-2:1998+A1:2009

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

Publication date:   Sep 16, 2010

General information

99.60 Withdrawal effective   Mar 1, 2017

CEN

CEN/TC 285 Non-active surgical implants

European Norm

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

NOW

WITHDRAWN
EN 12006-2:1998+A1:2009
99.60 Withdrawal effective
Mar 1, 2017

REVISED BY

PUBLISHED
EN ISO 7198:2017