DECRETO 10 agosto 2018 - Determinazione degli standard di sicurezza e impiego per le apparecchiature a risonanza magnetica. (18A06555)
IL MINISTRO DELLA SALUTE Visto il decreto del Presidente della Repubblica 8 agosto 1994, n. 542, recante «Regolamento recante norme per la semplificazione del procedimento di autorizzazione all'uso diagnostico di apparecchiature a risonanza magnetica nucleare sul territorio nazionale» e, in particolare, l'art. 2, comma 1, che prevede che gli «standards» di sicurezza ed impiego per le apparecchiature R.M. sono fissati con decreto del Ministro della sanita', sentito il parere del Consiglio superiore di sanita', l'Istituto superiore di sanita' e l'Istituto superiore per la prevenzione e la sicurezza del lavoro e aggiornati, con la medesima procedura, in relazione all'evoluzione tecnologica, anche su domanda delle imprese produttrici;
Visto il decreto del Ministro della sanita' 29 novembre 1985, recante «Disciplina dell'autorizzazione e uso delle apparecchiature diagnostiche a risonanza magnetica nucleare (R.M.N.) sul territorio nazionale» e successive modifiche, pubblicato nella Gazzetta Ufficiale 10 dicembre 1985, n. 290;
Visto il decreto del Ministro della sanita' 2 agosto 1991, recante «Autorizzazione alla installazione ed uso di apparecchiature diagnostiche a risonanza magnetica» e successive modifiche, pubblicato nella Gazzetta Ufficiale 20 agosto 1991, n. 194, S.O.;
Visto il decreto del Ministro della sanita' 3 agosto 1993, recante «Aggiornamento di alcune norme concernenti l'autorizzazione all'installazione ed all'uso di apparecchiature a risonanza magnetica» e successive modifiche, pubblicato nella Gazzetta Ufficiale 11 agosto 1993, n. 187;
Visto il decreto legislativo 24 febbraio 1997, n. 46 e successive modifiche, recante «Attuazione della direttiva 93/42/CEE, concernente i dispositivi medici»;
Visto il regolamento UE 2017/745 del Parlamento europeo e del Consiglio, del 5 aprile 2017, relativo ai dispositivi medici, che...
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