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Compliance In Focus
Posted by John Lehmann on Fri, May 4, 2012

What is a Device You Use at Least Twice a Day?

You might be surprised to find that the good ole toothbrush is a long time trusted medicalISO ToothBrush Standards device. The FDA Medical definition of a manual toothbrush is “a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.”  This seems to be pretty simple and straight forward! However, recently the International Organization for Standardization (ISO) released new standards for this manual device. The new requirements and test methods include:

  • Pass-fail criteria
  • Physical inspection guidelines
  • Fatigue resistance
  • Handle strength requirements and tests

This is the second edition of the international performance criteria for toothbrushes and it’s set to replace the first edition, taking our ordinary tooth brush to a new level! According the press release, “The latest version introduces a new requirement and test for determining the impact resistance of toothbrush handles.” So, next time you brush, you can hold your handle with confidence and smile with ISO Standards!

Do you have any thoughts on the new standards? Were you surprised to discover such a criteria exists for a simple toothbrush? Smile, and share your thoughts with us!

Photo Credit: el patojo

Topics: Medical Devices, International Organization for Standardization, FDA


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