Compliance With Legal And Normative Requirements - Vapormed Mighty Plus MEDIC Instructions For Use Manual

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10 C O M P L I A N C E W I T H L E G A L A N D
N O R M AT I V E R E Q U I R E M E N T S
Directive 93/42/EEC on medical devices
Medical electrical equipment IEC 60601-1
Medical electrical equipment: Requirements in home healthcare
environment IEC 60601-1-11
Medical electrical equipment ANSI/AAMI ES 60601-1
Medical electrical equipment CAN/CSA-C22.2 No. 60601
Electromagnetic compatibility according to IEC 60601-1-2
Notified Body:
TÜV SÜD Product Service GmbH
Ridlerstraße 65
80339 München, Germany
Manufacturer:
Storz & Bickel GmbH
In Grubenäcker 5-9
78532 Tuttlingen, Germany
33

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