Independent testing laboratory for cardiovascular medical devices according to ISO 5840 and other standards
Eurofins Medical Device Testing Aachen GmbH / ac.biomed GmbH
52074 AachenNew on Amplifa
About ac.biomed
ac.biomed is an independent testing laboratory in Aachen specializing in the testing of cardiovascular medical devices. As a European laboratory, the lab offers the full range of tests for heart valves according to ISO 5840. The test spectrum also includes blood pumps, cannulas, oxygenators, stents, vascular prostheses, arterial filters, and cardiotomy reservoirs according to relevant standards such as ASTM F1841, ISO 18242, ISO 18193, ISO 7199, ASTM F3067, ISO 7198, ISO 15675, and ISO 15674. Furthermore, the company offers customized test setups, next-generation mock loops, and in-vitro validation of computer-aided models according to ASME V&V 40, including Particle Image Velocimetry (PIV) and regulatory documentation. The testing methods and systems were developed and validated by the interdisciplinary team of biomedical engineers. The lab assists manufacturers, Notified Bodies, and authorities in the safe approval of innovative medical technology and is accredited and certified according to ISO 17025 (D-PL-22341-01-00) and ISO 9001:2015.
- Site
- Aachen
- Processes
- Testing of cardiovascular medical devices according to ISO 5840 (Heart Valves), Blood Pump Testing (ASTM F1841, ISO 18242, ISO 14708-5), Cannula Testing (ISO 18193), Oxygenator Testing (ISO 7199, FDA Guidance), Stent Testing (ASTM F3067, ISO 25539), Vascular Prosthesis Testing (ISO 7198), Arterial Filter Testing (ISO 15675), Cardiotomy Reservoir Testing (ISO 15674)
- Materials
- Heart Valve Testing, Oxygenator Testing, Stent Testing, Vascular Prosthesis Testing, Blood Pump Testing, Cannula Testing, Arterial Filter Testing, Cardiotomy Reservoir Testing
- Certificates
- ISO 17025, ISO 9001:2015, ISO 17025 (Accreditation D-PL-22341-01-00)
- Industries
- Medical Technology, Heart Valves, Cardiovascular Medical Devices
- 01
Inquiry and Test Specification
- 02
Selection or Development of Test Method
- 03
Individual Test Setup or Mock Loop
- 04
Execution of In-vitro Test
- 05
Evaluation and Regulatory Documentation
Test Procedures and Standards
Heart Valve Testing
Complete testing spectrum for heart valves including hydrodynamic testing, accelerated wear testing, and thrombogenicity.
Oxygenator Testing
Testing of gas exchange, heat exchanger, and pressure loss performance as well as blood cell damage.
Stent Testing
Radial Resistive Force and Chronic Outward Force for stents according to ISO 25539.
Vascular Prosthesis Testing
Water permeability, ingress pressure, and permeability of vascular prostheses.
Blood Pump Testing
Cavitation, hemolysis, hydraulic performance, and thrombogenicity of blood pumps.
Cannula Testing
Integrity, kink resistance, recirculation, pressure loss, and blood path integrity of cannulas.
Arterial Filter Testing
Filtration rate, filtration efficiency, air handling, and blood cell damage.
Cardiotomy Reservoir Testing
Air handling capacity, de-foaming, and blood cell damage.
Particle Image Velocimetry
Optical flow measurement for assessing flow fields.
In-vitro Validation of Computer-Aided Models
Validation of numerical simulations for regulatory argumentation.
Location
Aachen
DETesting Laboratory / Headquarters
Industries
Additional services
Quality and Accreditation
The laboratory is accredited according to ISO 17025 (D-PL-22341-01-00) and certified according to ISO 9001:2015. All testing methods and systems were developed and validated internally.
| Evidence | Aachen |
|---|---|
| ISO 17025 (Accreditation D-PL-22341-01-00) | |
| ISO 9001:2015 |