On 29 June 2015, the International Organization for Standardization, ISO, published a revised version of ISO 12836, the standard for assessing the precision of the scanning devices used in dentistry to create digital impressions for prosthetics. By precision we mean that a scanning device delivers the same digitized geometrical model of a test object every time within a given uncertainty in dimensions. Precision is the manufacturer’s responsibility.
NIOM’s experts are strongly involved in standardization activities enhancing the quality of medical devices used in dentistry (ISO/TC 106; CEN/TC 55 Dentistry) and in the development of standards for safety evaluation of medical devices (ISO/TC 194; CEN/TC 206 Biological evaluation of medical devices). NIOM also participates in quality management and corresponding general aspects for medical devices (ISO/TC 210; CEN-CLC/TC 3). New work has recently started in ISO/TC 210/WG 6: Application of post market surveillance systems to medical devices.