Hohenstein is an accredited testing laboratory for medical products. We provide neutral proof of efficacy and safety - a pre-requisite for approval or recognition of medical products with the European Medical Device Regulation (MDR).
- Biological, microbiological-hygienic and physical laboratory tests
- Technical documentation
- Hosiery compression effect (RAL-GZ 387/1)
- Sleeve compression effect (RAL-GZ 387/2)
- Hosiery system compression effect for the treatment of ulcus cruris (RAL-GZ 387/3)
- Bacterial filtration efficiency - BFE (DIN EN 14683 Annex B)
- Determination of breathability - pressure difference (DIN EN 14683 Annex C)
- Penetration of synthetic blood (ISO 22609)
- Evaluation of microbial cleanliness (bioburden) and biocompatibility
- Resistance to germ penetration in moist condition (DIN EN ISO 22610) and dry condition (DIN EN ISO 22612)
- Particle release in dry condition (linting) (DIN EN ISO 9073-10)
- Resistance to liquid penetration (EN ISO 811)
- Tensile strength in dry and wet state (EN ISO 29073-3)
- Evaluation of cleanliness (microbial/bioburden) and biocompatibility
- Bursting strength in dry and wet state (EN ISO 13938-2*)
*Deviating from the standard, the burst strength is conducted according to EN ISO 13938-2 instead of EN ISO 13938-1. EN ISO 13938-1 section 1 indicates no significant difference in the bursting strength results using hydraulic method (13938-1) and pneumatic method (13938-2) for pressures up to 800 kPa.
- Microclimate/physiological function of orthotics and bandages (AiF 11283)
- Function of foot bandages (DIN Spec 13257)
- Wear tests/mechanical irritation on human skin
- Wash-out/residues of biological components (e.g. coatings, active ingredients) by radioactive labeling and LSC
- Antimicrobial activity (DIN EN ISO 20743 / ISO 22196), antiviral activity according to test principle of ISO 18184 / ISO 21702
We specialize in customized testing for different products. Contact us to develop individual testing plans.
- Surface condition/condition assessment in new condition and after use/reprocessing via scanning electron microscopy (SEM)
- Homogeneity and removal of coatings
- Material determination by energy dispersive X-ray spectroscopy (EDX)
- Damage analysis
- Recognition of markings and inscriptions (e.g. UDI - Unique Device Identification)
We compare the function and biocompatibility of medical devices in new condition and after aging.
- Accelerated aging due to storage in the climate chamber
- Real-time storage under standard conditions
We check the function and biocompatibility of your medical device in new condition and after a specified number of cleaning cycles.
- Population of microorganisms- bioburden (DIN EN ISO 11737-1)
- Reprocessing in standardized washing procedures for household laundry (DIN EN ISO 6330), industrial laundry (DIN EN ISO 15797) or according to manufacturer specifications
- Biocidal effect in instrument disinfection, surface disinfection and disinfecting washing procedures
- Hygiene monitoring/microbiological-environmental testing, e.g. in the production environment