TecnoBody S.r.l –PROKIN Systems
ANNEX A - Norms and Standards References
PROKIN-MF/ PROKIN-E Systems Normative References
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The product is a medical device conforming to 93/42/CEE European Normative and
classified according to rule 12 of annex IX as
Class I (M)
Conforming to EN 60601- 1 ( CEI 62- 5 ) European Normative, III° edition
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Class I equipment
Type B applied parts
Continuous functioning
Protection level against water and dust entrance: IPX0
Besides, the system is conforming to the European Normative:
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EN 60601-1-2 III° edition
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MF-PK-MANOP-02
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PROKIN-MF /PROKIN-E SYSTEM – OPERATOR’S MANUAL
