Abstract

This document 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. This document is supplemental to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. 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 document 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.

Begin

2021-02-25

WI

00285142

Planned document number

DIN EN ISO 25539-3

Project number

02703290

Responsible national committee

NA 027-05-06 AA - Cardiovascular implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Responsible international committee

ISO/TC 150/SC 2/WG 3 - Vascular prostheses  

draft standard

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO/DIS 25539-3:2023); German and English version prEN ISO 25539-3:2023
2023-08
Order from DIN Media

previous edition(s)

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011); German version EN ISO 25539-3:2011
2012-03

Order from DIN Media