Washer-disinfector Biokompatibility (ISO 10993)

System: G 7836 CD/Miele

In the Miele washer-disinfector, almost all reprocessable medical devices and laboratory equipment can be cleaned and disinfected thermally at up to 95 °C and/or chemo-thermally at up to 65 °C with suitable disinfectants, while meeting general or epidemic hygiene requirements.

Useful tips:

Suitable samples:
  • Surgical instruments
  • minimally invasive instruments
  • anaesthesia and intensive care instruments
  • baby bottles and teats
  • operating theatre shoes
  • laboratory equipment from research and production as well as all analytical and preparative areas including microbiology and biotechnology
Sample specifications:
  • Suitable for cleaning in a washer-disinfector
Range/Options:
  • Thermal disinfection up to 95˚C (drying up to 115˚C).
  • Connection for up to four process chemicals

Application(s)

  • Cleaning of exhibits

  • Reprocessing validation

Standards

  • Food and Drug Administration. Final Guidance for Industry and FDA Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling, VIII. Validation of Cleaning Process (2015)
  • Association for the Advancement of Medical Instrumentation. (2016). AAMI TIR30:2011/€2016. A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. Abschnitt 7.5. Arlington: AAMI
  • ISO 15883

Contact:  Yves Viecelli +41 32 644-2051

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