Schmalz G, Browne R M
Department of Oral Pathology, University of Birmingham, School of Dentistry, St. Chad's Queensway, UK.
Int Dent J. 1995 Aug;45(4):275-8.
The advent of the European Union requires the biological evaluation of all medical devices used in dentistry prior to their general availability for clinical use. Biological evaluation is one component of the 'Essential Requirements' with which all devices need to conform. Such conformity will result in the issue of the CE mark. To facilitate this process, harmonised European standards are required. It is the policy of The European Committee for Standardisation (CEN) that, whenever possible, the relevant International standards will be adopted as European standards.
欧盟的出现要求在牙科中使用的所有医疗器械在普遍用于临床之前进行生物学评价。生物学评价是所有器械都需符合的“基本要求”的一个组成部分。这种符合将导致CE标志的颁发。为推动这一进程，需要统一的欧洲标准。欧洲标准化委员会（CEN）的政策是，只要有可能，相关的国际标准将被采纳为欧洲标准。
