標準號：BS EN 1641-2009
中文標準名稱：牙科學.牙科用醫療器械.材料
英文標準名稱：Dentistry - Medical devices for dentistry - Materials
標準類型：C33
發布日期：2009/11/30 12:00:00
實施日期：2009/11/30 12:00:00
中國標準分類號：C33
國際標準分類號：11.060.10
引用標準：EN 980;EN 1041;EN 21563;EN 21942-1-1991;EN 21942-2-1992;EN ISO 1564;EN ISO 1942-5-1994;EN ISO 3107;EN ISO 4049;EN ISO 4823;EN ISO 6872;EN ISO 6873;EN ISO 6874;EN ISO 6876;EN ISO 6877;EN ISO 7405;EN ISO 7491;EN ISO 7551;EN ISO 9333;EN ISO 9693;EN ISO 9917-
適用范圍：This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. For the purposes of this standard these materials are defined as restorative and orthodontic materials. Dental implants are specificallyexcluded and described in EN 1642. This standard also specifies general requirements for materials used in the practice of orthodontics. This standard includes requirements for intended performance, design attributes, components, sterilization, packaging, marking, labelling, and information supplied by the manufacturer.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.