Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN 1639:2009
• Năm ban hành / Publication date: 2009
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Dentistry - Medical devices for dentistry - Instruments
• Phạm vi áp dụng / Scope of standard: 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.