DIN EN ISO 25539-1:2017-09
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
Hardcopy , PDF
07-03-2021
English
01-01-2017
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National foreword
National Annex NA (informative) - Bibliography
European foreword
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
[OJ L 169] aimed to be covered
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for endovascular system
5 Intended performance
6 Design attributes
7 Materials
8 Design evaluation
9 Post-market surveillance
10 Manufacturing
11 Sterilization
12 Packaging
Annex A (informative) - Relationship between testing
requirements and device attributes and potential
failure modes
Annex B (informative) - Description of clinical and
device effects of failure
Annex C (informative) - Bench and analytical tests
Annex D (informative) - Test methods
Bibliography
Describes requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge.
| DevelopmentNote |
Together with DIN EN ISO 25539-2 E, it supersedes DIN EN 14299 E. (03/2009) DIN EN ISO 25539-1 E issue 08-2009 remains valid alongside this standard until 15-03-2020. (09/2017)
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| DocumentType |
Standard
|
| Pages |
140
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
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| Status |
Superseded
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| Supersedes |
| Standards | Relationship |
| EN ISO 25539-1:2017 | Identical |
| ISO 25539-1:2017 | Identical |
| 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 |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| 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 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 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/TR 37137:2014 | Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants |
| 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 |
| ASTM F 3044 : 2014 | Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| ISO 5840-1:2015 | Cardiovascular implants Cardiac valve prostheses Part 1: General requirements |
| ASTM G 71 : 1981 | GUIDE FOR CONDUCTING AND EVALUATING GALVANIC CORROSION TESTS IN ELECTROLYTES |
| ASTM F 3067 : 2014 | Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 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 |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| ASTM F 2942 : 2013 | Standard Guide for <emph type="bdit">in vitro</emph> Axial, Bending, and Torsional Durability Testing of Vascular Stents |
| ISO 80369-7:2016 | Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ASTM F 2914 : 2012 | Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
| 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 |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| 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 |
| ISO 10555-4:2013 | Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters |
| ISO 16429:2004 | Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods |
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