Regulatory Focus™ > News Articles > ISO Releases New Device Standard for Toothbrushes

ISO Releases New Device Standard for Toothbrushes

Posted 30 April 2012 | By Alexander Gaffney, RAC 

The International Organization for Standardization (ISO) has released a new standard for a common medical device: the toothbrush.

In ISO 20126:2012, Dentistry-Manual Toothbrushes-General Requirements and Test Methods, the organization outlines "pass-fail criteria, physical inspection guidelines, fatigue resistance, chemical challenge and handle strength requirements and tests, as well as marking, labeling and packaging guidelines for manual toothbrushes."

"[C]ommon requirements are needed to compare different products," said Professor Hiroshi Nakajima, Chair of the committee which developed the standard. The updated standard replaces one released in 2005, and includes new requirements for testing the impact resistance of toothbrush handles.


Read more:

ISO - Smile with confidence when you brush your teeth with ISO


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