NF EN ISO 25539-3
Cardiovascular implants - Endovascular devices - Part 3 : vena cava filters
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.
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.
Le présent document fixe des exigences particulières relatives aux dispositifs endovasculaires. Il vient à l'appui des exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux.
- Avant-proposv
- IntroductionVI
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1 Domaine d'application1
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2 Références normatives2
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3 Termes et définitions2
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4 Exigences générales5
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4.1 Classification5
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4.2 Taille5
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5 Performances prévues5
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6 Caractéristiques de conception5
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6.1 Généralités5
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6.2 Ensemble gaine/dilatateur pour système de filtration endovasculaire5
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6.3 Système de filtration5
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6.4 Filtre6
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6.5 Filtre optionnel6
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6.6 Ensemble gaine/dilatateur pour système de retrait/conversion endovasculaire6
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6.7 Système de retrait/conversion6
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6.8 Systèmes endovasculaires7
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7 Matériaux7
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8 Évaluation de la conception7
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8.1 Généralités7
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8.2 Échantillonnage8
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8.3 Conditionnement des échantillons d'essai8
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8.4 Rapport8
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8.5 Essais au banc et essais analytiques9
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8.6 Évaluation préclinique in vivo24
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8.7 Évaluation clinique28
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9 Pharmacovigilance32
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10 Fabrication33
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11 Stérilisation33
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11.1 Produits fournis stériles33
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11.2 Produits fournis non stériles33
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11.3 Résidus de stérilisation 33
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12 Emballage33
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12.1 Protection contre les dommages lors du stockage et du transport33
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12.2 Marquage34
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12.3 Informations fournies par le fabricant35
- Annexe A (informative) Caractéristiques des dispositifs endovasculaires - Filtres caves - Considérations techniques et cliniques37
- Annexe B (informative) Descriptions des effets matériels potentiels de la défaillance, des modes de défaillance et descriptions des effets cliniques préjudiciables53
- Annexe C (informative) Essais au banc et essais analytiques58
- Annexe D (informative) Méthodes d'essai63
- Annexe E (informative) Exemples de termes pour l'utilisation clinique des filtres caves91
- Bibliographie93
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