General
• The product has been designed in accordance with Regulation (EU)
2017/745 on medical devices (MDR)
• ISO 14971
Safety
• IEC 60601-1
• AAMI ES 60601-1
• CSA C 22.2 No.60601-1
Environmental Compliance
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
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