Standardization of orthodontic products--does it make sense?
Since 1994, the DIN (Deutsches Institut für Normung e.V.) has had a German working group named "Orthodontic Products" working toward establishing standardized norms for orthodontic products. In the USA, a similar working group called "Orthodontic Materials" was established in 1996 at the ADA (American Dental Association). Working at the ISO level since 1997, an international team has been in charge of unifying the standards already set at national levels. It is the aim of this article to report on the current state of standardization in Germany and internationally. The standards already published for wires (DIN 13971, ADA Spec. 32), for brackets and tubes (DIN 13971-2, ADA Spec. 100) and for elastomeric elements (DIN 13901) have been considered, as have problems occurring with ISO standards (ISO/CD 15841 and ISO/CD 15841-2) and DIN 13904-1. We demonstrate that the demands made of these products by the orthodontists who use them have lead to reasonable quality standards. Thanks to clearly-defined testing methods, orthodontic products can now be tested and their compliance with these minimum standards can be compared. In fact, the standards that have been agreed upon help both the product manufacturers and their users to improve product quality and, ultimately, the success of orthodontic treatment.
Sernetz
Friedrich
F
Dentaurum J. P. Winkelstroeter KG, Turnstrasse 31, 75228 Ispringen, Germany. Friedrich.Sernetz@dentaurum.de
D003764:Dental Materials / Q000592:standards*; D019544:Equipment Failure Analysis / Q000592:standards*; D005858:Germany; D017408:Guidelines as Topic; D038622:Internationality; D008422:Materials Testing / Q000592:standards*; D009967:Orthodontic Appliances / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D012015:Reference Standards
D003764:Dental Materials