BS EN 1640-2009 牙科学.牙科用医疗器械.设备

标准号：BS EN 1640-2009
中文标准名称：牙科学.牙科用医疗器械.设备
英文标准名称：Dentistry - Medical devices for dentistry - Equipment
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：11.060.20
引用标准：EN 980;EN 1041;EN 1639;EN 21942-1-1991;EN 21942-4-1993;EN 60601-1;EN 60601-2-22;EN 60601-1-4;EN 60825-1;EN 62304;EN ISO 6875;EN ISO 7488;EN ISO 7494-1;EN ISO 7494-2;EN ISO 9680;EN ISO 9687;EN ISO 10637;EN ISO 10650-1;EN ISO 10650-2;EN ISO 11143;EN ISO 114
适用范围：This European Standard specifies general requirements for 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 apply to 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 EN 1639.Tests for demonstrating compliance with this standard are contained in the level 3 standards, if appropriate.