Customized Medical Device Testing

• Hygiene monitoring /microbiological environmental testing, e.g. in the production environment
• Population of microorganisms - bioburden (ISO 11737-1)
• Analysis of endotoxins - LAL test (Ph. Eur. 2.6.14, ANSI/AAMI ST72 and DIN EN ISO 11737-3)
• Standard test method for microbial ranking of porous packaging materials (exposure chamber method - ASTM F 1608)
• Microclimate/physiological function of orthotics and bandages (AiF 11283)
• Function of foot bandages (DIN SPEC 13257*)
  *The new DIN SPEC 13257 specifies requirements for single-use foot dressings in medical foot treatment 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.
• Wear tests/mechanical irritation on human skin
• Wash-out/residues of biological components (e.g. coatings, active ingredients) by radioactive labeling and LSC
• Antimicrobial efficacy (ISO 20743 / ISO 22196), antiviral activity (ISO 18184 / ISO 21702)
• 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

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