Biocompatibility | Shelf Life | Hygiene | Compression Stockings | ​​​​​​​Masks | ​​​​​​​Surgical/Cleanroom | ​​​​​​​Others | ​​​​​​​EU MDR

Neutral testing and proof for medical devices.

From consumer safety to product development to complaint prevention and marketing, lives depend on it.

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

Biocompatibility

  • Cytotoxicity (DIN EN ISO 10993-5)
  • Chemical characterization (DIN EN ISO 10993-18)
  • Tests for irritation/mucosal damage (HET CAM test)
  • Biocompatibility of coatings for medical devices - Our innovative test methods collect valuable preclinical data
  • Further tests on request

More on harmful substances

Efficacy/function of medical compression stockings

  • 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)

More on medical compression

Efficiency/function of medical face masks according to DIN EN 14683

  • 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

More on Medical Face Masks

Efficacy/function of surgical and cleanroom textiles according to DIN EN 13795-1 and -2

  • 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)
  • Bursting strength in dry and wet state (EN ISO 13938-2)*
  • Tensile strength in dry and wet state (EN ISO 29073-3)
  • Evaluation of cleanliness (microbial/bioburden) and biocompatibility
     

* Deviating from the requirement standard DIN EN 13795-1, the burst strength is not carried out according to EN ISO 13938-1, but according to EN ISO 13938-2. EN ISO 13938-1 section 1 indicates that there is no significant difference in the bursting strength results achieved using tests according to EN ISO 13938-1 (hydraulic method) and EN ISO 13938-2 (pneumatic method) for pressures up to 800 kPa.

Testing of other medical devices - Examples

  • Surface condition and damage patterns using scanning electron microscopy (SEM) and SEM-EDX
  • 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), antiviral activity (ISO 18184)

We specialize in customized testing for different products and queries. Contact us to develop individual testing plans.

Aging and shelf life

We compare the function and biocompatibility of medical devices in new condition and after aging.

  • Accelerated storage in the climate chamber
  • Real-time storage under standard conditions

Microbiological purity, cleaning/reprocessing

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

Start with product development.

Diversified?

So is Hohenstein. We turn research into solutions tailored to unique market requirements.

Contact
Ben Mead
Managing Director
Hohenstein Institute America