A standard on digital impression devices – and methods for assessing accuracy, has just been published. The standard was developed by an international working group headed by NIOM’s senior scientist John Tibballs, and managed by the Japanese Industrial Standards Committee (JISC).
The standard, published by the International Organization for Standardization (ISO) was made public on August 13. It is titled ISO 20896 Dentistry – Digital impression devices – methods for assessing accuracy. It opens for regulation within the European Union of intra oral scanners as medical devices with a measuring function.
Senior scientist John Tibballs is clear in his advise to any clinician considering purchase of a chairside scanning system. “Ask the manufacturer for the results of testing according to the new standard.”
To achieve compliance with the standard, manufacturers need to have undertaken, and reported the results from, a series of measurements designed to quantify precision (repeatability) and accuracy (or its negation: that is bias).
The publication is the outcome of a three-year project. The starting point was a standard (No. 132) published by the American Dental Association in 2015. It had been established that scanning for large prosthetic devices could be grossly inaccurate, even when performed by competent practitioners.
The new standard provides the means needed to measure progress in attaining better digital impressions. The clinician considering purchase of a chairside scanning system is well advised to ask the manufacturer for the results of testing according to the new standard.