Proof of efficacy and safety of medical devices

Neutral proof of the efficacy and safety of your product is a prerequisite for the medical device to be compliant with the European Medical Device Regulation (MDR) and thus be allowed to be marketed in Europe.

We support you in providing this evidence for your technical documentation. We offer biological, chemical and physical laboratory tests.

Hohenstein is an accredited testing laboratory for medical products by the German Accreditation Body (Deutsche Akkreditierungsstelle (DAkkS))

Biocompatibility

  • Cytotoxicity according to DIN EN ISO 10993-5
  • Chemical characterization according to DIN EN ISO 10993-18
  • Test for irritation / mucosal damage by means of HET CAM test
  • Further tests on request

Please also contact us on the subject of biocompatible coatings for medical devices. With our innovative test setups, we collect valuable preclinical data in this area.

Efficacy/function of medical compression stockings

  • Compression effect of hosiery according to RAL-GZ 387/1
  • Compression effect of armsleeves according to RAL-GZ 387/2
  • Compression effect of hosiery systems for the treatment of ulcus cruris according to RAL-GZ 387/3

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

  • Bacterial filtration efficiency (BFE) according to DIN EN 14683 Annex B
  • Determination of breathability (pressure difference) according to DIN EN 14683 Annex C
  • Penetration of synthetic blood according to ISO 22609
  • Evaluation of microbial cleanliness (Bioburden) and biocompatibility

Efficacy/function of surgical clothing, surgical drapes and clean-air clothing according to DIN EN 13795-1 and -2

  • Resistance to germ penetration in moist condition according to DIN EN ISO 22610
  • Resistance to germ penetration in dry condition according to DIN EN ISO 22612
  • Particle release in dry condition (linting) according to DIN EN ISO 9073-10
  • Resistance to liquid penetration according to EN ISO 811
  • Bursting strength in in dry and wet state according to EN ISO 13938-2*
  • Tensile strength in dry and wet state according to EN ISO29073-3
  • Evaluation of cleanliness microbial/bioburden and of 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.

Efficacy/function and safety of other medical devices - examples

  • Surface condition and damage patterns using scanning electron microscopy (SEM) and SEM-EDX
  • Microclimate / physiological function of orthoses and bandages according to AiF 11283
  • Function of foot bandages according to DIN Spec 13257
  • Wearing tests / Mechanical irritation on human skin
  • Wash-out / residues of biological components (e.g. coatings, active ingredients) by radioactive labeling and LSC
  • Antimicrobial activity according to DIN EN ISO 20743, antiviral activity following ISO 18184

Is your product or your question not mentioned here? Just contact us. We are also happy to develop individual test setups for testing your product.

Aging and shelf life

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

We would be pleased to check the function and biocompatibility of your medical device comparatively in new condition and after aging.

Microbiological purity, cleaning/reprocessing

  • Population of microorganisms (bioburden) according to DIN EN ISO 11737-1
  • Reprocessing in standardized washing procedures according to DIN EN ISO 6330 (household laundry) and DIN EN ISO 15797 (industrial laundry) or individually according to manufacturer's specifications
  • Hygiene monitoring /microbiological environmental testing, e.g. in the production environment

We are happy to check the function and biocompatibility of your medical device comparatively in new condition and after a certain number of reprocessing cycles.

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