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Certificates

Certificates

Test results confirming the safety and reliable disinfection of the ETD3 system have been compiled. Please find below a full list of which certificates are available for the ETD3 when using the PAA process:


  • Micobiological Testing of the Automated Reprocessing of Flexible Endocopes in the Washer-Disinfector ETD3 PAA-Version, Olympus Europe Ltd., Hamburg, Germany
  • Efficacy of EndoDet and EndoDis + EndoAct for cleaning and disinfection of Olympus Gastroscope Type GIF-XT30 with the Endo Thermo Disinfector ETD3 tested according to the recommendations for ’Testing and Evaluating the Cleaning and Disinfection Efficacy of Endoscope Washer/Disinfectors and Disinfection Automates’ with Enterococcus Faecium
  • Bactericidal efficacy of Olympus EndoDis + Olympus EndoAct tested according to EN13727
  • Sporicidal efficacy of Olympus EndoDis + Olympus EndoAct tested against Bacillus subtilis EN 13704
  • Efficacy Olympus EndoDis + Olympus EndoAct against yeasts.  Test C. albicans accoding to EN 13624
  • Efficacy against viruses of Olympus EndoDis + Olympus EndoAct tested against Polio-, Adeno-, Siminavirus 40 according to the DVV guideline - Ecolab
  • On the virus-efficacy of the processing procedure under near use-related conditions of EndoDis, EndoDet and EndoAct tested adapted to the recommendations for ’Testing and Evaluating the Cleaning and Disinfection Efficacy of Endoscope Washer/Disinfectors and Disinfection Automats’ of the ETD2 Cleaning and Disinfection Process against Bovine Parvovirus (BPV). 
  • Determination of the Bactericidal Activity of the disinfectant ’EndoDis/EndoAct’ (Olympus Optical Co. Europe) at 35oC and in the presence of specific interfering substances (clean conditions) against Enterococcus Faecium CIP 5855 according to the french standard NFT72-300
  • Determination of the Bactericidal Acitivity of the disinfectant ’EndoDis/EndoAct’ (Olympus Optical Co. Europe) according to the french standard NFT72-170
  • Expert Judgement on the Efficiency of the Self-Disinfection Program Olympus ETD 3 with Olympus EndoDis and EndoAct
  • Evaluation of a water treatment system for Endoscope Washer-Disinfector 
  • Olympus EndoDis Assessment of the biocompatibility regarding the principles laid down in the ISO 10993: Biological evaluation of medical devices
  • Ecological evaluation of the cleaning Product Olympus EndoDet for setup of endoscopes in the Endo- Thermo- Disinfector (ETD)
  • Department of Toxicology VTB Biology/Product Safety.  Olympus EndoDet Hazard assessment
  • Material safety data sheet EndoDet, Material saftey data sheet EndoDis, Material safety data sheet EndoAct - Ecolab
  • Statement on the Cleaning Efficacy and Protein Fixation of Disinfectants Based on Peracetic Acid - Ecolab
  • Declaration of conformity for EndoDet, EndoDis and EndoAct - Ecolab
  • Declaration of conformity for ETD3 - Miele
  • Evaluation Report, Olympus Endo-Thermodisinfector, ETD3 Plus PAA, HIRL, Birmingham
  • ETD3-PAA plus, HTM-2030 Compliance Equipment Design Analysis

 

 

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