DANSK DSF/PREN ISO 25539-3 PDF

This document specifies requirements for the evaluation of vena cava filter systems (filters and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for development of in vitro test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 – Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this document will be necessary. This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this part of ISO 25539 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. This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this part of ISO 25539 might be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. This document is not applicable to temporary filters (e.g., tethered) that need to be removed after a defined period of time; issues associated with viable tissues and non-viable biological materials; and procedures and devices (e.g., venous entry needle) used prior to the vena cava filter procedure. Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 2 – Absorbable implants are within the scope of ISO/TR 17137. Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 3 – Vascular device-drug combination products are within the scope of ISO 12417-1, and some coating properties are within the scope of ISO 25539-4.