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Normas DIN – AENOR
DIN EN ISO 25539-1:2009-01

DIN EN ISO 25539-1:2009-01

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 + Amd 1:2005); German version EN ISO 25539-1:2008 / Note: A transition period, as set out in DIN EN ISO 25539-1 (2009-08), exists until 2010-03-21.

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003 + Amd 1:2005); Version allemande EN ISO 25539-1:2008 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 25539-1 (2009-08) jusqu'à 2010-03-21.

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003 + Amd 1:2005); Deutsche Fassung EN ISO 25539-1:2008 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 25539-1 (2009-08), bis 2010-03-21 beachten.

Fecha Anulación:
2019-08 /Withdrawn
Equivalencias internacionales:

EN ISO 25539-1 (2008-10)

ISO 25539-1 AMD 1 (2005-07)

ISO 25539-1 (2003-03)

Relación con otras normas DIN:
Resumen:
Part 1 of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630. This International Standard is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities. This International Standard is in addition applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
Keywords:
Acceptance specification, Cardiology, CE marking, Definitions, Design, Endovascular, English language, Instructions for use, Marking, Materials, Medical devices, Medical equipment, Packages, Properties, Prosthetic devices, Specification (approval), Sterile, Sterilization (hygiene), Surgical implants, Testing, Vascular prostheses
183,08
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