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Standards Help Save Lives during American Diabetes Month.

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November 12, 2009 - Providing specific requirements and test methods for syringes used to inject insulin, ISO 8537:2007, Sterile single-use syringes, with or without needle, for insulin, covers syringes for use with 40 and 100 units of insulin/ml. Another standard, ISO 15197:2003, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, outlines performance requirements for self-testing blood-glucose monitoring systems.

Standards Save Lives During American Diabetes Month


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American National Standards Institute (ANSI)
11 West 42nd St., 13th Flr.
New York, NY, 10036
USA



Press release date: November 3, 2009

The American Diabetes Association is launching a national movement this November to Stop Diabetes. As activists bring the facts of diabetes to light during American Diabetes Month, standards are in place to assist those afflicted with the disease in maintaining healthful lifestyles.

Type 1 diabetics control their blood glucose levels by injecting insulin. An International Standard from the International Organization for Standardization (ISO) provides specific requirements and test methods for syringes used to inject insulin. ISO 8537:2007, Sterile single-use syringes, with or without needle, for insulin, covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).

This standard was developed by ISO Technical Committee (TC) 84, Devices for administration of medicinal products and intravascular catheters. The American National Standards Institute (ANSI)-accredited U.S. Technical Advisory Group (TAG) administrator for this TC is the Association for the Advancement of Medical Instrumentation (AAMI), an ANSI organizational member and accredited standards developerWhen the body does not produce or use insulin properly, glucose remains in the blood, resulting in several potentially life-threatening complications. All diabetics need to keep a close watch on their blood glucose levels to prevent damage to the kidneys, eyes, nerves, and cardiovascular system. Another ISO standard, ISO 15197:2003, In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, outlines the performance requirements for self-testing blood-glucose monitoring systems, assuring that the tests diabetics conduct at home are accurate and reliable.

This standard was developed by ISO TC 212, Clinical laboratory testing and in vitro diagnostic test systems. The U.S. holds the chairmanship and the secretariat of this TC, with Donald Powers, Ph.D., serving as chairman and the Clinical and Laboratory Standards Institute (CSLI) as secretariat. CSLI, an ANSI organizational member and accredited standards developer, is also the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to TC 212.

As part of the Stop Diabetes campaign, the American Diabetes Association is urging all Americans to confront, fight, and ultimately stop diabetes. The Association provides a number of suggestions of how to get involved, including sharing personal stories, participating in fundraising walks and bicycle rides, and learning more about the disease, at stopdiabetes.com.
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