Medical device evaluation

Medical device evaluation

The microbiological safety of medical devices is an issue that concerns many actors
(manufacturers, distributors, users and patients). Biotech-Germande laboratory was created
for medical devices manufacturers and users to address this problem. Our goal is to
provide high-quality expertise, technical assistance and high added-value scientific researches
to help you meet regulatory requirements. As a microbiology laboratory dedicated to the
management of infection risk, we perform standard or customized testing to meet your
specific needs:

  • Medical devices evaluation – type tests– performance qualification
    • Endoscope and instrument washer-disinfector according to NF EN ISO 15883
    • Storage cabinets for heat sensitive endoscopes according to NF S 98-030,…
  • Determination of the biocidal activities of room decontamination process according to NFT
    72-281
  • Evaluation of the cleaning efficacy of medical device reprocessing products or process
    according to NF EN ISO 15883-5 (OPA, biuret, ninhydrine, TOC,…),
  • Evaluation of the antimicrobial efficacy of detergent, disinfectants or any other biocidal
    agents :
    • According to international or European standards (AOAC tests, TGA
      guidelines, NF EN 1040, NF EN 1275, …)
    • Against biofilms
  • Customized tests to help you in the design of the critical parameters of the medical device.

You can follow in real time the progress of your study by logging into your customer’s area.
Our experts and scientists are in direct contact with you to discuss and interpret the results and
provide you with the highest quality assistance.

Informations

Adress

Biotech-Germande
163 Avenue Luminy - case 927
13009 Marseille
Tel : 04 91 82 82 40
Email : biotech-germande@eurofins.com