Medical device testing and Validation of chemical and thermal disinfection and cleaning methods

Medical device manufacturers are obliged to provide validated reprocessing instructions. Profound knowledge and experience is offered by our staff to guide our customers' products through these obligations. Development and efficacy testing of manual and automatic cleaning and disinfection processes is performed by application of microbiological and proteinchemical methods. Furthermore, the issue of sensitive tissues obliged to be sterile is approached by effective chemical disinfection procedures validated by a wide choice of indicator microorganisms.

All microbiological tests are performed in accordance with international standards, norms and regulations:

 

  • ISO 14160 Validation of Chemical Disinfection/Sterilization Procedures for Tissues
  • DIN 58953-6 Microbial Impermeability Testing)
  • ISO 3826-1 Microbial Impermeability Testing
  • Validation of Manual and Automatic Cleaning and Disinfection Processes according to ISO 17664, ISO 15883, ASTM E2314, ASTM E1837, RKI-publications, FDA-Guidances, AAMI TIR30, AAMI TIR12
  • Validation of Steam Sterilization Processes according to ISO 17664, ISO 17665, ISO 14937, AAMI TIR12
  • ISO 11137 part 1-2 Validation of Gamma Sterilization
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