BS EN 1639-2009 牙科学.牙科用医疗器械.仪器

标准号：BS EN 1639-2009
中文标准名称：牙科学.牙科用医疗器械.仪器
英文标准名称：Dentistry - Medical devices for dentistry - Instruments
标准类型：C33
发布日期：2009/11/30 12:00:00
实施日期：2009/11/30 12:00:00
中国标准分类号：C33
国际标准分类号：11.060.25
引用标准：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
适用范围：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.