標準號：BS EN 1639-2009
中文標準名稱：牙科學.牙科用醫療器械.儀器
英文標準名稱：Dentistry - Medical devices for dentistry - Instruments
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：11.060.25
引用標準：EN 556-1;EN 980;EN 1041;EN 1640;EN 13060;EN 21942-1-1991;EN 21942-3-1993;EN 23964;EN 29168;EN 60601-1;EN ISO 1797-1;EN ISO 1797-2;EN ISO 2157;EN ISO 3630-1;EN ISO 3630-2;EN ISO 3630-3;EN ISO 3823-1;EN ISO 3823-2;EN ISO 7153-1;EN ISO 7492;EN ISO 7711-1;EN
適用范圍：This European Standard specifies general requirements for instruments used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, reprocessing, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not apply to any necessary energy source to which an instrument needs to be connected. These energy sources are covered by EN 1640.Tests for demonstrating compliance with this European Standard are contained in the level 3 standards, if appropriate.