EN 14299:2004

Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Sep 1, 2008

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 European Standard specifies specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.
With regard to safety, this standard gives in addition to EN ISO 14630:1997 and
EN 12006-3:1998 specific requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
This European Standard applies to arterial stents and endovascular prostheses used in the aorta, cervical segments of cerebral arteries, coronary arteries, intra-cerebral arteries, peripheral arteries, pulmonary arteries, supra-aortic arteries and visceral arteries. It also includes endovascular prostheses used to treat aneurysms, arterial stenoses, or other vascular abnormalities.
NOTE 1 Delivery systems are included in this standard if they comprise an integral component of the deployment of the implant.
NOTE 2 Covered stents used as occluders are included in this standard.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
EN 14299:2004
99.60 Withdrawal effective
Sep 1, 2008

REVISED BY

WITHDRAWN
EN ISO 25539-2:2008

WITHDRAWN
EN ISO 25539-1:2008