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Eurofins France >> Hygiène Hospitalière >> Endoscope Washer-Disinfector validation (EWD)
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Endoscope Washer-Disinfector validation (EWD)

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Detailed view of an endoscope washer-disinfector in a laboratory. The device features stainless steel racks and a red emergency stop button, ensuring optimal hospital hygiene. Eurofins offers endoscope washer-disinfector (EWD) validation services to ensure the safety and efficacy of disinfection procedures in healthcare facilities.

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.

Infographic showing the endoscope washer-disinfector validation process by Eurofins. Detailed steps: pre-treatment (checking endoscope integrity), cleaning (removal of dirt), rinsing and disinfection (elimination of bacteria), and final rinse. The cleaned and disinfected endoscope is ready for use. Eurofins offers its expertise at every step to ensure optimal hospital hygiene. Key figures on the importance of cleaning and disinfecting endoscopes. Due to their increasing complexity, these steps are essential in their life cycle. Using an endoscope washer-disinfector (EWD) is the most standardized and fastest method, 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.

Infographic illustrating the validation cycle of endoscope washer-disinfectors (EWD) by Eurofins. The steps include self-disinfection, the cleaning phase, the disinfection phase, and the complete cycle (cleaning and disinfection). Each phase is crucial to ensure the hygiene and safety of endoscopes. Eurofins provides services to validate these steps and ensure compliance with strict standards.

 

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 ?

Reconnaissance Internationale
 International
recognition
Our knowledge of international standards, particularly European ones, ensures compliance with them during the validation of your medical devices. Consult the list of our accreditations here.

Suivi personnalisé
Personalised Monitoring
We provide you with a study manager who will become your privileged contact. They will offer you tailored support throughout the process. Contact us and meet our experts.

Expert en microbiologie
Microbiology Expertise
Our specialised team in microbiology and medical hygiene conducts risk factor analysis in the design of your medical devices as an independent laboratory.


Proven Expertise 
Our 30 years of experience enables us to provide you with high-quality services. Our experts accompany you to offer a solution tailored to your needs and provide personalized support. Contact our medical device evaluation experts.

 

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