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ISO 25539-2:2012

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

Cardiovascular implants Endovascular devices Part 2: Vascular stents

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

22-10-2020

Language(s)

English, French

Published date

05-12-2012

DevelopmentNote
Supersedes ISO/DIS 25539-2. (12/2012)
DocumentType
Standard
Pages
92
ProductNote
THIS STANDARD ALSO REFERS TO ICH Q1A (R2), ICH Q1B,ICH Q1D
PublisherName
International Organization for Standardization
Status
Withdrawn
SupersededBy
Supersedes

DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
ASTM F 2942 : 2013 Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents
I.S. EN ISO 7198:2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
ASTM F 3211 : 2017 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
DIN EN ISO 10555-4:2013-11 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
I.S. EN ISO 10555-4:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS (ISO 10555-4:2013)
14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
AAMI ISO TIR 17137 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS
ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
17/30250386 DC : 0 BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS
11/30235365 DC : 0 BS EN ISO 10555-4 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS
DIN EN ISO 7198 E : 2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
BS EN ISO 10555-4:2013 Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters
UNI EN ISO 10555-4 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS
ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
DIN EN ISO 7198:2017-07 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
EN ISO 10555-4:2013 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
ISO 17327-1:2018 Non-active surgical implants — Implant coating — Part 1: General requirements
I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
UNE-EN ISO 10555-4:2014 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)

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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