SS-EN-14299 › Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
Document Center Inc. is an authorized dealer of SIS standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
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 and EN 12006-3 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.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Designation Name
SS-EN 14299:2004
Revision Level
2004 EDITION
Status
Superseded
Publication Date
Sept. 24, 2004
Language(s)
English
Page Count
40
International Equivalent
EN 14299:2004(IDT)