ANSI - American National Standards Institute
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Standards Make a Difference on World Diabetes Day


New York, Nov 14, 2007

More than 17,000 people developed diabetes today. Tomorrow, that figure may rise even higher. To help raise global awareness of this chronic, debilitating, and costly disease, World Diabetes Day is observed each year on November 14.

Diabetes occurs as a result of problems with the production and supply of insulin. Type 1 diabetics do not produce enough of this essential hormone and require insulin injections to survive. Type 2 diabetics can produce insulin, but their bodies cannot use the hormone effectively.

Though the disease kills 3.8 million people worldwide each year, several key standards help the medical community to diagnose and treat both type 1 and type 2 diabetes, allowing patients to live longer, healthier lives.

November is American Diabetes Month
  • 20.8 million Americans have diabetes – that’s 7% of the population

  • At least 54 million Americans are pre-diabetic

  • If trends continue, one out of three Americans born after 2000 will develop diabetes in their lifetime

Source: American Diabetes Association
Type 1 diabetics control their blood glucose levels by injecting insulin. A standard from the International Organization for Standardization (ISO) provides specific requirements and test methods for sterile single-use syringes. ISO 8537:2007 covers syringes for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml (U-100).

When the body does not produce or use insulin properly, glucose remains in the blood, resulting in several potentially life-threatening complications. Both type 1 and type 2 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, outlines the performance requirements for self-testing blood glucose monitoring systems, ensuring that the tests diabetics conduct at home are accurate and reliable.

Doctors and patients alike can be assured of the safety of diabetic care equipment thanks to a document from ANSI-accredited standards developer the Association for the Advancement of Medical Instrumentation (AAMI). AAMI HE48:1993 offers design and engineering guidelines that take human factors and ergonomics into account to ensure that optimum user and patient safety are reflected in medical device design.

To learn more about diabetes and its impact in the United States, visit the American Diabetes Association website.

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