標(biāo)準(zhǔn)號(hào)：BS EN 1639-2009
中文標(biāo)準(zhǔn)名稱(chēng)：牙科學(xué).牙科用醫(yī)療器械.儀器
英文標(biāo)準(zhǔn)名稱(chēng)：Dentistry - Medical devices for dentistry - Instruments
標(biāo)準(zhǔn)類(lèi)型：C33
發(fā)布日期：2009/11/30 12:00:00
實(shí)施日期：2009/11/30 12:00:00
中國(guó)標(biāo)準(zhǔn)分類(lèi)號(hào)：C33
國(guó)際標(biāo)準(zhǔn)分類(lèi)號(hào)：11.060.25
引用標(biāo)準(zhǔn)：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.