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(12) PATENT APPLICATION PUBLICATION
(19) INDIA (21) Application No.: 00632/KOL/2003 A
(22) Date of filing of Application: 15/12/2003 (43) Publication Date: 09/06/2006
(54) Title of the invention: METHOD FOR MANUFACTURING A STERILIZED AND CALIBRATED BIOSENSOR-
BASED MEDICAL DEVICE
(51) International classification : A61L 2/00
(31) Priority Document No : 10/324,933
(32) Priority Date : 20.12.2002
(33) Name of priority country
(86) International Application No and
: U.S.A
: NIL
Filing Date
:
(87) International Publication No : NIL
(61) Patent of addition to Application No : NIL
Filed on : NIL
(62) Divisional to Application No : NIL
Filed on : NIL
(57) Abstract:
A method for manufacturing a sterilized and calibrated
biosensor-based medical device (e.g., an integrated
biosensor and lancet medical device) includes sterilizing a
biosensor-based medical device that contains a biosensor
reagent composition (e.g., an analyte specific enzyme and
mediator biosensor reagent composition). The sterilizing
can be accomplished using, for example, a gamma
radiation based technique. Thereafter, the biosensor
reagent composition of the sterilized biosensor-based
medical device is calibrated. Another method for
manufacturing a sterilized and calibrated biosensor-based
medical device includes first assembling and packaging a
plurality of biosensor-based medical devices that include a
biosensor reagent composition. The packaged biosensorbased
medical devices are then sterilized using a radiationbased
sterilization technique, to create a plurality of
sterilized, packaged biosensor-based medical devices.
Thereafter, the sterilized and packaged biosensor-based
medical devices are calibrated. The calibration can be
accomplished, for example, using a statistical sample of
the plurality of sterilized, packaged biosensor-based
medical devices.
(FIG.1 )
(71) Name of Applicant: LIFESCAN, INC.
Address of the Applicant: 1000 GIBRALTAR
DRIVE, MILPITAS, CALIFORNIA, 95035,
U.S.A
(72) Name of the Inventor: (1) TEODORCZYK
MARIA
Filed U/S 5(2) before The Patents (Amendment)
Act, 2005: NO
The Patent Office Journal 09/06/2006 10938