Method and system for sterilizing an analyte sensor

  • US 8,802,006 B2
  • Filed: 08/27/2012
  • Issued: 08/12/2014
  • Est. Priority Date: 04/10/2008
  • Status: Active Grant
First Claim
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1. A method of sterilizing a glucose monitoring assembly, the method comprising:

  • assembling a glucose sensor and a sensor introducer to form a glucose sensor assembly, wherein the glucose sensor comprises at least one electrode, an enzyme layer, and a glucose diffusion limiting layer;

    assembling a medical device assembly including sensor electronics;

    packaging the glucose sensor assembly in a first container;

    packaging the first container in a second container that includes at least one glucose sensor assembly;

    irradiating the second container including the at least one glucose sensor assembly at a predetermined dose level using electron beam irradiation; and

    exposing the medical device unit assembly to a chemical solution for a second predetermined time period to sterilize the medical device assembly.

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