Blood Glucose Monitoring System & Medical Devices: Cleaning & Disinfection Procedure Validation

Bioscience Laboratories Inc. conducts the FDA-required validation of cleaning and disinfection procedures based upon AAMI TIR12:2010 “Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers”. 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, such as the housing or touchpad buttons.
• Demonstration using the standard ASTM E1053 and ASTM E2362 tests that the disinfection protocol is effective against Hepatitis B virus and other blood-borne viruses.
• 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.

ASTM

These are among the most commonly used ASTM methods, please note that these are not our only capabilities. After discussing your needs with our experts, we are able to purchas...

ASTM - E2362

Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection This test method may be used to determine if a pre-saturated or impre...

ASTM - E1053

Standard Test Method to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Non-porous Environmental Surfaces This test method is used to evaluate t...

Virology Testing Laboratory

BioScience Laboratories can assist with new product development, R&D projects, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabili...