top of page
Glossary Term
< Return to Main Navigation

ISO 25539 (Cardiovascular Implants – Endovascular Devices)

Definition

ISO 25539 is an international standard that provides guidelines for the design, testing, and evaluation of cardiovascular implants used in endovascular procedures. This standard ensures that these devices meet stringent safety and performance criteria to support their use in treating cardiovascular diseases.

Relevance to the MedTech Industry

ISO 25539 ensures that cardiovascular implants such as stents and grafts are safe, effective, and durable under physiological conditions. It provides manufacturers with a framework to demonstrate compliance with regulatory requirements and maintain the reliability of these critical medical devices.

Additional Information & Related Terms

Key Sections of ISO 25539

  1. ISO 25539-1: Endovascular Prostheses

    • Specifies requirements for devices like vascular grafts and aortic stent-grafts.

  2. ISO 25539-2: Vascular Stents

    • Focuses on safety and performance testing for balloon-expandable and self-expanding stents used in peripheral or coronary arteries.

  3. ISO 25539-3: Vena Cava Filters

    • Provides requirements for devices designed to prevent pulmonary embolism by capturing blood clots in the vena cava.


Examples of Applications

  • Coronary Stents: Used to reopen narrowed arteries in patients with coronary artery disease.

  • Endovascular Prostheses: Devices for repairing aneurysms or dissections in the aorta.

  • Peripheral Vascular Stents: Implanted in arteries outside the heart, such as the legs or neck, to restore blood flow.

  • Vena Cava Filters: Temporary or permanent implants designed to trap blood clots and prevent pulmonary embolism.

Related Terms

  • Biocompatibility Testing: Ensures materials used in implants meet safety standards.

  • ISO 10993: Complements ISO 25539 by providing guidelines for biocompatibility testing of medical device materials.

  • Fatigue Testing: A critical requirement under ISO 25539 to assess the durability of cardiovascular implants.

  • Post-Market Surveillance (PMS): Supports long-term monitoring of device safety and performance in real-world settings.

bottom of page