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EN ISO 25539-3:2011

Current

Current

The latest, up-to-date edition.

Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)

Published date

01-12-2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Attributes of endovascular devices
        - Vena cava filters - Technical and clinical
        considerations
Annex B (informative) - Descriptions of potential device
        effects of failure and failure modes and descriptions
        of detrimental clinical effects
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Annex E (informative) - Examples of terms for clinical use
        of vena cava filters
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

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.

Committee
CEN/TC 285
DevelopmentNote
Supersedes EN 12006-3. (01/2012)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Current
Supersedes

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters
ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ISO 17475:2005 Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14630:2012 Non-active surgical implants — General requirements
ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO/TS 15539:2000 Cardiovascular implants Endovascular prostheses
ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use

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