Sernetz Friedrich
Dentaurum J. P. Winkelstroeter KG, Turnstrasse 31, 75228 Ispringen, Germany.
J Orofac Orthop. 2005 Jul;66(4):307-18. doi: 10.1007/s00056-005-0503-7.
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.
自1994年以来，德国标准化协会（DIN，Deutsches Institut für Normung e.V.）成立了一个名为“正畸产品”的德国工作组，致力于制定正畸产品的标准化规范。在美国，1996年美国牙科协会（ADA，American Dental Association）成立了一个类似的工作组，名为“正畸材料”。自1997年起在国际标准化组织（ISO）层面开展工作，一个国际团队负责统一各国已制定的标准。本文旨在报告德国及国际标准化的现状。文中考虑了已发布的关于弓丝（DIN 13971，ADA规范32）、托槽和管（DIN 13971 - 2，ADA规范100）以及弹性元件（DIN 13901）的标准，以及ISO标准（ISO/CD 15841和ISO/CD 15841 - 2）和DIN 13904 - 1中出现的问题。我们证明，使用这些产品的正畸医生对它们的要求已促成了合理的质量标准。由于有明确规定的测试方法，现在可以对正畸产品进行测试，并比较其是否符合这些最低标准。事实上，已达成一致的标准有助于产品制造商及其用户提高产品质量，并最终提高正畸治疗的成功率。
