Gamma Knife CE certification

 Gamma Knife CE certification should follow the EU technical regulations and EN standards. For the EU has issued Directive 18 categories of industrial products, from the structure of these instructions, the instructions which can be divided into vertical and horizontal directive. Vertical instructions are specific products for the object, such as the Medical Device Directive; the level of instruction for a variety of products, such as electromagnetic compatibility directive, which applies to all electrical and electronic components products. For the Gamma Knife, the applicable instructions have fourteenth term, the first and fifth, namely: 93/42 / EEC Medical Device Directive, 73/23 / EEC Low Voltage (LVD) Directive and 89/336 / EEC Electromagnetic compatibility (EMC) directive. EU standards to support these instructions is: (1) EN60601-1 medical electrical equipment Part I: General requirements for safety; (2) EN60601-1-1 Medical Electrical Equipment Part I: General requirements for safety and correcting the first number; (3) EN60601-2-11 Medical electrical equipment Part: γ beam therapy equipment for the safety requirements; (4) EN60601-1-2 Medical Electrical Equipment Part I: General requirements for safety 1.2 Parallel Electromagnetic compatibility - Requirements and test . The first of which (1), (2) (3), the standard is the Gamma Knife Low Voltage (LVD) test is based on: (4) criteria is based on the Gamma Knife electromagnetic compatibility (EMC) testing.