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STANDARDER
För att tillförsäkra säkerheten har stimulatorn utformats, tillverkats och distribuerats i enlighet med kraven i
EU-direktiv 93/42/EEG, om medicintekniska produkter.
Stimulatorn uppfyller även kraven i IEC 60601-1 om allmänna fordringar beträffande säkerhet för elektrisk
utrustning för medicinskt bruk, IEC 60601-1-2 om elektromagnetisk kompatibilitet samt IEC 60601-2-10 om
särskilda fordringar på nerv- och muskelstimulatorer.
Enligt aktuella gällande internationella standarder måste en varning utfärdas beträffande placering av
elektroder på bröstkorgen (ökad risk för hjärtflimmer).
Stimulatorn uppfyller även kraven i direktiv 2002/96/EG om avfall som utgörs av eller innehåller elektriska eller
elektroniska produkter (WEEE).
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