ISO 7198: Cardiovascular implants and extracorporeal systems – Vascular prostheses – Tubularvascular grafts and vascular patches
ISO 7198:2020 specifies design, testing, and performance requirements for tubular vascular prostheses, including synthetic grafts, vascular patches, and coated or treated materials. It covers aspects such as:
- Material requirements (biocompatibility, durability)
- Mechanical properties (compliance, burst strength, suture retention)
- Preclinical testing (fatigue, degradation, and in vitro evaluations)
- Sterilization and packaging considerations
Endolab performs different tests within this standard, including tests for circumferential tensile strength, wall thickness, and dynamic radial compliance.
