Endoscope Washer-Disinfector validation (EWD)
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.
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 :
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At Eurofins Biotech-Germande laboratory, we can validate your EWD by performing:
The tests riquired to comply with ISO 15883-1, 15883-4 et 15883-5 :
- 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:
- 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.
Glossary:
ISO: International Organisation for Standardisation
Annexe D: Method for microbiological assessment of liquid transport system disinfection
Surrogate: Substitution device representative of an endoscope with transparent tubes for visualising what happens inside an endoscope.
Why choose Eurofins ?
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Contact us:
Eurofins Biotech-Germande SAS
✉ biotech-germande@etfr.eurofins.com
☎ +33 (0)4 42 33 24 04
505, rue Louis Berton, Bât. 2, 13590 Aix-en-Provence