NF EN 12006-3+A1

Le présent document fixe des exigences particulières relatives aux dispositifs endo-vasculaires.

Le présent document spécifie les exigences relatives aux prothèses endovasculaires. En matière de sécurité, il définit les exigences des performances prévues, des caractéristiques de conception, des matériaux, de l'évaluation de conception, ainsi que la fabrication, la stérilisation, l'emballage et les informations fournies par le fabricant. Il inclut les prothèses endovasculaires utilisées dans le traitement des anévrysmes artériels, des sténoses artérielles ou d'autres anomalies vasculaires. Il inclut aussi les systèmes de largage s'ils font partie intégrante du système de mise en place des prothèses endovasculaires. Parmi les dispositifs d'occlusion vasculaire, seuls les dispositifs d'occlusion iliaque contralérale utilisés comme partie intégrante d'un dispositif aorto-uni-iliaque sont abordés. Il ne s'applique pas aux techniques et dispositifs utilisés avant l'introduction du système endovasculaire, tels que les dispositifs d'angioplastie transluminate percutanée. Le présent document a été élaboré dans le but de se conformer aux exigences essentielles de la Directive européenne 93/42/CE sur les dispositifs médicaux.

ISO 25539-2:2008 specifies requirements for vascular stents, 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, which specifies general requirements for the performance of non-active surgical implants. The scope of ISO 25539-2:2008 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008. Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent. Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents. With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.

ISO 25539-3:2011 specifies requirements for vena cava filters, 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. ISO 25539-3:2011 supplements ISO 14630, which specifies general requirements for the performance of non-active surgical implants. The following are within the scope of ISO 25539-3:2011: vena cava filters used to prevent pulmonary embolism by mechanical filtration in the inferior vena cava: while ISO 25539-3:2011 might be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address use of filters in other implantation sites; sheath/dilator kits, providing that they comprise an integral component of the access, delivery or retrieval/conversion of the vena cava filter. delivery systems, providing that they comprise an integral component of the deployment of the vena cava filter. optional filters that can be retrieved or converted, and permanent filters together with their associated endovascular systems: while ISO 25539-3:2011 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. The following are outside the scope of ISO 25539-3:2011: temporary filters (e.g. tethered) that need to be removed after a defined period of time; coatings, surface modifications, and/or drugs; issues associated with viable tissues and non-viable biological materials; degradation and other time-dependent aspects of absorbable materials; procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure.