Why should we work together?

Our participation in numerous scientific events keeps us up to date with the latest knowledge, methods and technologies relating to endoscope washer-disinfectors (EWD). This knowledge enables us to provide a personalised support to meet your expectations and the requirements of current standards.

Supporting our customers is a priority, and throughout the validation process you will be accompanied and advised by our teams of experts to certify that your EDS meets ISO 15883-1, 15883-4 and 15883-5 standards

 

Since 2020, we have carried out more than 65 studies on endoscope washer-disinfectors.

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Key figures 

Because of the increasing complexity of endoscopes, cleaning and disinfection are critical steps during their lifecycle. Cleaning/disinfection using an Endoscope Washer Disinfector (EWD) is the most standardized and fastest method. It is subject to strict regulations.

To determine the biocidal effectiveness of an EWD, it is necessary to conduct a specific validation program, in compliance with the requirements of ISO standards 15883-1, 15883-4 and 15883-5.

The 15883 standard evaluates EWD, among others, on the following points :

  • Self-disinfection cycle,
  • Cleaning phase,
  • Disinfection phase,
  • Complete cycle (cleaning and disinfection),
  • Efficiency of the water treatment system.
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How do we validate your LDEs?

We offer to validate your LDEs by conducting additional tests and studies.

The tests riquired to comply with ISO 15883-1, 15883-4 et 15883-5

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Self-disinfection:
Annexe D method 1,
Annexe D method 2,
Annexe F (chimical self-disinfection).

Cleaning phase:
Biofilm test,
Endoscope test,
Surrogate test.

Disinfection phase:
Surrogate test.

Complete cycle (cleaning and disinfection):
Endoscope test,
Surrogate test (optionnal).

Determination of filter and water treatment system efficacy

Additional studies:

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  • Risk analysis to determine your Type Test Groups,
  • Identification of the most resistant microorganism,
  • Selection of soils: method based on Annex B of standard 15883-5: 2021.

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Contactez notre laboratoire expert

Eurofins Biotech Germande SAS

505 Rue Louis Berton, ZAC du Quartier de l'Enfant, 13290 Aix-en-Provence, France