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I.S. EN ISO 25539-2:2012

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CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS (ISO 25539-2:2012)

Available format(s): Hardcopy, PDF

Withdrawn date: 31-03-2021

Language(s): English

Published date: 01-01-2012

Publisher: National Standards Authority of Ireland

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For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Table of Contents - (Show below) - (Hide below)

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
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

Abstract - (Show below) - (Hide below)

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

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Development Note	Supersedes I.S. EN 14299. (10/2008) Supersedes I.S. EN 12006-3. (03/2011)
Document Type	Standard
ISBN
Pages
Published
Publisher	National Standards Authority of Ireland
Status	Withdrawn
Superseded By	I.S. EN ISO 25539-2:2020
Supersedes	I.S. EN ISO 25539-2:2009

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
ISO 25539-2:2012	Identical
EN ISO 25539-2:2012	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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