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CHAPTER 2
2.2.4.
International Standards Compliance
The Mistral complies with the following international standards and
directives:
EMC Standards:
IEC 60601-1-2:2001 + A1:2004
Clause 36.201 (Emission);
Clause 36.202 (Immunity);
Harmonized Standards:
Medical Electrical Equipment – Part 1:
General Requirements for Safety:
IEC60601-1:1988 + A1:1991 + A2: 1995
EU Directives:
- Low Voltage Directive 2006/95/EC
- Electromagnetic Compatibility Directive
2004/108/EC
- Medical Device Directive 93/42/EEC –
Class IIa device marked as CE 0344 of the KEMA Notified Body
(only for the Acne Clearance and Psoriasis Care applications)
Mistral User Manual
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