Tiêu chuẩn quốc tế

• Số hiệu / Standard Number: EN 45502-2-3:2010
• Năm ban hành / Publication date: 2010
• Tình trạng / Status: A - Còn hiệu lực
• Tên tiếng Anh / Title in English: Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
• Phạm vi áp dụng / Scope of standard: This Part 2-3 of EN 45502 specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways. Devices which treat hearing impairment via means other than electrical stimulation are not covered by this European Standard. The tests that are specified in EN 45502 are type tests and are to be carried out on samples of a device to show compliance. This Part of EN 45502 is also applicable to NON-IMPLANTABLE PARTS and accessories of the devices (see NOTE 1). The electrical characteristics of the IMPLANTABLE PART shall be determined by either the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this particular standard shall apply.