DIN EN 1640:2010
牙科学.牙科用医疗器械.设备.德文版本EN 1640-2009
Dentistry - Medical devices for dentistry - Equipment; German version EN 1640:2009
- 标准号
- DIN EN 1640:2010
- 发布
- 2010年
- 发布单位
- 德国标准化学会
- 当前最新
- DIN EN 1640:2010
- 引用标准
- EN 1041 EN 1639 EN 21942-1:1991 EN 21942-4:1993 EN 60601-1 EN 60601-1-4 EN 60601-2-22 EN 60825-1 EN 62304 EN 980 EN ISO 10637 EN ISO 10650-1 EN ISO 10650-2 EN ISO 11143 EN ISO 132 EN ISO 6875 EN ISO 7488 EN ISO 7494-1 EN ISO 7494-2 EN ISO 9680 EN ISO 9687
- 被代替标准
- DIN EN 1640:2008 DIN EN 1640:2004
- 适用范围
- This European Standard specifies general requirements for items of dental equipment used in the practice of dentistry and which are medical devices. It includes requirements for intended performance, design attributes, components, packaging, marking, labelling, and information supplied by the manufacturer.This European Standard does not include requirements for dental X-ray equipment.This European Standard does not apply to any dental instruments connected to an item of dental equipment. These instruments are covered by the level 2 and level 3 standards for dental instruments.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.