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CEN
EN ISO 25539-2:2012

EN ISO 25539-2:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

Superseded date

07-10-2020

Superseded by

EN ISO 25539-2:2020

Published date

01-12-2012

Publisher

Comite Europeen de Normalisation

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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 -
        Vascular stents - Technical and clinical consideration
Annex B (informative) - Bench and analytical tests
Annex C (informative) - Definitions of reportable clinical events
Annex D (informative) - Test methods
Annex E (informative) - Supplement to fatigue durability test
        analytical approach
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements of
         EU Directive 93/42/EEC
Bibliography

Describes requirements for vascular stents, based upon current medical knowledge.

Committee
CEN/TC 285
DevelopmentNote
Supersedes EN 14299. (10/2008) Supersedes EN 12006-3. (03/2011)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

BIP 0113 : 2012 GUIDE TO EUROPEAN MEDICAL DEVICE TRIALS AND BS EN ISO 14155

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
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 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
EN 14299:2004 Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
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
ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters

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