Overview
EN ISO 5840-1:2021/A1:2025 is Amendment 1 to ISO 5840-1:2021, adopted by CEN as a European Standard in March 2025. It updates the general requirements for cardiac valve prostheses (cardiovascular implants) and clarifies terminology, test conditions and test methods used for valve hydrodynamics, leakage, durability and pediatric testing. The amendment is intended to be implemented as a national standard across CEN member states by September 2025.
Key topics and requirements
- Revised terms and definitions: updates to entries such as accessory, adverse event (AE) and regurgitant volume, including notes clarifying measurement scope and applicability.
- Hydrodynamic and pressure test conditions: new tables replace previous values for differential pressures across closed valves for aortic/mitral and pulmonary/tricuspid positions, defining categories from normotensive to very severe hypertensive (e.g., aortic normotensive 120/80 mmHg; very severe hypertensive 210/120 mmHg). For in vitro minimum performance testing, aortic peak systolic and end diastolic pressures are the control pressures.
- Durability testing guidance: specifies that the differential pressure condition shall be maintained for at least 5% of the cycle during durability testing.
- Pediatric test parameters: Annex E tables updated with pediatric subpopulation parameters (systolic duration, MAP, beat rate, cardiac output) and recommended steady back pressures and flow rates for newborns through adolescents.
- Test method clarifications:
- Simplified valve test fixtures allowed as alternatives to full aortic/mitral transcatheter fixtures.
- Pressure difference measurements over a 5–30 l/min range in 5 l/min increments with at least five measurements per point.
- Leakage measured at five equidistant back pressures (per Tables 3 and 4) with at least five measurements at each pressure; valves should be opened between repeated measurements.
- Notes specify test fluid properties (physiological saline, specific gravity ~1.005 g/ml, viscosity ~1.0 cP).
- Documentation and data: sample requirements clarified; fatigue/durability data must be represented by actual test duration - extrapolation beyond tested cycle range is not acceptable.
Applications and who uses it
This amendment is essential for:
- Medical device manufacturers of surgical and transcatheter heart valve prostheses (design, verification and validation).
- Test laboratories performing hydrodynamic, leakage and durability testing.
- Regulatory and conformity assessment bodies and notified bodies assessing safety and performance claims.
- Clinical researchers and device engineers developing pediatric and ViV/ViR (valve-in-valve / valve-in-ring) solutions.
Related standards
- ISO 5840 series (Part 2 and Part 3 referenced for in vitro and transcatheter testing procedures).
- National adoptions: EN ISO 5840-1:2021/A1:2025 (CEN members).
Keywords: ISO 5840-1 amendment, cardiac valve prostheses standard, cardiovascular implants, valve hydrodynamic testing, transcatheter valve testing, pediatric valve testing, adverse event definition, regurgitant volume, durability testing.
