ISO 25539-2:2012
Withdrawn
Withdrawn
View Superseded by
Cardiovascular implants — Endovascular devices — Part 2: Vascular stents
Available format(s)
Hardcopy , PDF
Language(s)
English, French
Published date
12-05-2012
Withdrawn date
04-09-2025
Superseded by
US$96.00
Excluding Tax where applicable
| Committee |
ISO/TC 150/SC 2
|
| 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Withdrawn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 |
| Standards | Relationship |
| NF EN ISO 25539-2 : 2013 | Identical |
| NBN EN ISO 25539-2 : 2013 | Identical |
| NEN EN ISO 25539-2 : 2012 | Identical |
| NS EN ISO 25539-2 : 2012 | Identical |
| I.S. EN ISO 25539-2:2012 | Identical |
| PN EN ISO 25539-2 : 2013 | Identical |
| SS-EN ISO 25539-2:2012 | Identical |
| ANSI/AAMI/ISO 25539-2:2012 | Identical |
| BS EN ISO 25539-2:2012 | Identical |
| EN ISO 25539-2:2012 | Identical |
| DIN EN ISO 25539-2:2013-05 | Identical |
| UNE-EN ISO 25539-2:2013 | Identical |
| 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 |
| BS EN ISO 10555-4:2013 | Intravascular catheters. Sterile and single-use catheters 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) |
| 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 |
| 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 12417-1:2016 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015) |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| 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 |
Summarise
US$96.00
Excluding Tax where applicable
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