ISO 25539-1:2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

Standard No.

ISO 25539-1:2017

Release Date

2017

Published By

International Organization for Standardization (ISO)

Latest

ISO 25539-1:2017

Scope

This document specifies 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. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices. This document is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra- lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices. Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555-4, specific to the use of balloons with endovascular prostheses. This document is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices. The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices. NOTE 1 Cardiac valved conduits are within the scope of ISO 5840-1. Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document. NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417. This document does not address the requirements for, and the evaluation of, viable tissues and non- viable biologic materials used in the construction of endovascular prostheses.  The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document. NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

ISO 25539-1:2017 Referenced Document

• ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*， 2024-04-20 Update
• ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants*， 2024-04-20 Update
• ASTM F2129-15 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices*， 2024-04-20 Update
• ASTM F2182-11 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging*， 2024-04-20 Update
• ASTM F2213-06 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment*， 2024-04-20 Update
• ASTM F2394-07 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System*， 2024-04-20 Update
• ASTM F2477-07 Standard Test Methods forin vitro Pulsatile Durability Testing of Vascular Stents*， 2024-04-20 Update
• ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*， 2024-04-20 Update
• ASTM F2914-12 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices*， 2024-04-20 Update
• ASTM F2942-13 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents*， 2024-04-20 Update
• ASTM F3044-14 Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants*， 2024-04-20 Update
• ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use*， 2024-04-20 Update
• ASTM F746-04 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials*， 2024-04-20 Update

ISO 25539-1:2017 history

• 2017 ISO 25539-1:2017 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
• 2005 ISO 25539-1:2003/Amd 1:2005 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses; Amendment 1: Test methods
• 2014 ISO 25539-1:2003 Cardiovascular implants — Endovascular devicesPart 1:Endovascular prostheses