EN ISO 25539-3:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
30-06-2012
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 |
Withdrawn
|
Supersedes |
Standards | Relationship |
UNI EN ISO 25539-3 : 2012 | Identical |
NS EN ISO 25539-3 : 2011 | Identical |
SN EN ISO 25539-3:2012 | Identical |
NF EN ISO 25539-3 : 2012 | Identical |
UNE-EN ISO 25539-3:2012 | Identical |
BS EN ISO 25539-3:2011 | Identical |
NEN EN ISO 25539-3 : 2011 | Identical |
I.S. EN ISO 25539-3:2011 | Identical |
ISO 25539-3:2011 | Identical |
DIN EN ISO 25539-3:2012-03 | Identical |
PN EN ISO 25539-3 : 2012 | Identical |
NBN EN ISO 25539-3 : 2012 | Identical |
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 |
ASTM G 71 : 1981 | GUIDE FOR CONDUCTING AND EVALUATING GALVANIC CORROSION TESTS IN ELECTROLYTES |
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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