Fraunhofer Institute for Cell Therapy and Immunology IZI
Testing laboratory ASSESS-MED – Service Center for the Assessment of Medical Devices
Independent product testing for extracorporeal therapy systems – in accordance with regulatory requirements, industry-focused, and research-based.
About ASSESS-MED
The ASSESS-MED laboratory is part of the Extracorporeal Therapy Systems department at the Fraunhofer IZI, Rostock branch. It offers standardized, industry-oriented product testing in the field of blood purification to support a faster transfer of new technologies to the market. The laboratory conducts manufacturer-independent tests of blood purification products such as dialyzers, hemofilters, and adsorbers, and operates according to specific product standards for testing medical devices, such as DIN EN ISO 8637-1 to -3.
Through close scientific cooperation with the Rostock University Medical Center, in particular with the Section for Nephrology and its affiliated dialysis unit (Prof. Dr. med. Steffen Mitzner, Dr. med. Sebastian Koball) and the Department of Anesthesiology and Intensive Care Medicine (Prof. Dr. med. Christian Schewe, PD Dr. med. Gerd Klinkmann), a powerful alliance of applied research, clinical expertise, and industrial testing practice is formed.
ASSESS-MED is funded by the European Union through the European Regional Development Fund (ERDF) as well as the Ministry of Economics, Employment and Health of the state of Mecklenburg-Vorpommern.
Funding reference: GW-21-0001
(Previously funded under the reference: GW-19-0001.)
EUROPEAN UNION European Regional Development Fund
Service portfolio & competencies
The ASSESS-MED testing laboratory has a broad spectrum of standardized testing procedures at its disposal:
Standard-compliant performance testing (according to DIN EN ISO 8637-1 to -3) of dialyzers, hemo(dia)filters, plasma filters:
- Clearance (diffusive permeability)
- Sieving coefficient (convective permeability)
- Ultrafiltration coefficient
- Plasma filtration
In-vitro biocompatibility tests according to DIN EN ISO 10993-1ff:
- Cytotoxicity analyses (according to DIN EN ISO 10993-5)
- Hemocompatibility: Hemolysis, coagulation, platelet & complement activation (according to DIN EN ISO 10993-4)
Further services:
- Endotoxin retention / removal
- Hemoadsorption / plasma adsorption model
- Use of all types of test fluids (human / animal)
- Miniaturized dialyzer / filter / adsorber models for testing patient samples
- Analyses of various clinically relevant molecules in-house or in cooperation with certified medical laboratories (list not exhaustive):
- Water-soluble and protein-bound uremic toxins
- (Large) middle molecules
- Pro- / anti-inflammatory mediators
- Plasma proteins
- Albumin binding capacity
- Pharmacological active substances
- Endotoxin
- Publications in peer-reviewed journals
- If required, development/establishment of further assays and models according to customer requirements. Feel free to contact us!
Accreditation & quality management
The laboratory has implemented a quality management system according to ISO/IEC 17025:2018.
An application for accreditation with the German Accreditation Body (DAkkS) is currently under review. Testing procedures such as the performance evaluation according to DIN EN ISO 8637-1-3 are already being carried out under the QMS.
Cooperation models
The ASSESS-MED testing laboratory offers various forms of collaboration, ranging from:
- Testing orders according to standards or individual specifications
- Consulting on product-related issues
- Joint development projects (e.g., ZIM, KMU-innovativ)
- Support of preclinical and clinical studies in cooperation with the Rostock University Medical Center