Medical Devices

hy·labs performs microbiological analysis of medical devices following GLP guidelines. The laboratory is ISO 9001 certified and has facilities of a CLASS 10,000 CLEAN ROOM and a CLASS 100 L.A.F.

Following is a partial list of services performed by the laboratory:

  • Validation of Sterilization Processes with the aid of Biological Indicators (B.I.)
    • Resistance Performance Test for:
    • Steam Sterilization
    • Dry Heat Sterilization
    • Ethylene Oxide (ETO) Sterilization
  • Validation of Sterilization Process by Gamma Irradiation
  • Verification of Spore Population in B.I.
  • Bioburden determination
  • Bacterial Identification
  • Endotoxin Validation and Testing by the LAL Method
  • Accelerated Aging Service 

For custom-made tests contact our Laboratory Manager: judi@hylabs.co.il

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