Blood Glucose Monitoring | Bioscience Labs

Blood Glucose Monitoring Systems: Cleaning & Disinfection Procedure Validation

Blood Glucose Monitoring Systems: Cleaning & Disinfection Procedure Validation

BioScience Laboratories Inc. conducts the FDA required validation of cleaning and disinfection procedures.  Each evaluation will include the following FDA requirements:

  • Selection of an EPA approved registered cleaning and disinfection product that does not result in the physical deterioration of the device overall, or deterioration of any device component as the housing or touch pad buttons.
  • Demonstration using the standard ASTM E 1053 and ASTM E2362 tests that the disinfection protocol is effective against Hepatitis B virus.
  • Demonstration that the Blood Glucose Monitoring Systems (BGMS) is robust to cleaning and disinfection procedures after multiple cleaning and disinfection cycles.
  • Description of how the cleaning and disinfection procedures affect the port of the meter.
  • Confirmation that the disinfectant does not cloud the face/display of the meter and does not corrode or erode the plastic housing or buttons.
  • GLP Protocol with acceptance criteria.
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ASTM - E2362

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ASTM- E1053

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