NF EN ISO 25539-3

NF EN ISO 25539-3

February 2012
Standard Cancelled

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.

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Collections

National standards and national normative documents

Publication date

February 2012

Number of pages

108 p.

Reference

NF EN ISO 25539-3

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Classification index

S94-203-3

Print number

1 - 06/02/2012

International kinship

ISO 25539-3:2011

European kinship

EN ISO 25539-3:2011
Sumary
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.
Replaced standards (1)
NF EN 12006-3+A1
July 2009
Standard Cancelled
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3 : endovascular devices

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.

Standard replaced by (1)
NF EN ISO 25539-3
October 2024
Standard Current
Cardiovascular implants - Endovascular devices - Part 3 : vena cava filters

This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with 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, a 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 document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the 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 document can 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 covered in ISO/TS 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 covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.

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