Customized Medical Device Testing

• Microclimate/physiological function of orthotics and bandages (AiF 11283)
• 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 (ISO 20743 / ISO 22196), antiviral activity (ISO 18184 / ISO 21702)
• Hygiene monitoring /microbiological environmental testing, e.g. in the production environment
• Population of microorganisms - bioburden (ISO 11737-1)
• Function and biocompatibility in new condition and after a specified number of cleaning cycles: standardized washing procedures for household laundry (ISO 6330), industrial laundry (ISO 15797) or according to manufacturer's specifications
• Function of foot bandages (DIN SPEC 13257*)
  *The new DIN SPEC 13257 specifies requirements for foot dressings in medical foot treatment for single use and defines corresponding test procedures for their compliance. The DIN SPEC was developed in workshops according to the PAS method Pedilay Care GmbH with the help of Hohenstein.

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