MO003-GB 18/05/06
Operative Manual
Rev.0
Page 9 of 34
1.5 Manufacturer’s declaration of conformity CE
The Company:
RIMSA P. LONGONI S.r.l.
Via Monterosa, 18/20/22 - 20038 SEREGNO (MI) - ITALIA
declares on its own responsibility that the Medical Illumination Device for surgical and diagnostic use:
SATURNO WALL
APPLICARE
ETICHETTA
constructed by RIMSA P.LONGONI S.r.l., conforms to the Attachment VII of the 93/42 EEC Directive
of June 14
th
1993 and applied in Italy by the Legislative Decree N° 46 of February 24
th
1997 moreover, it
is in conformity with the following safety regulation EN 60601-2-41.
Classification with reference to article 9 and Attachment IX of the 93/42/CEE Directive
DURATION:
Short term (Par.1 “Definitions”, art.1, paragraph 1.1, attachment IX)
DESCRIPTION: Non invasive Medical Device (Par.1 “Definition”, art.1, paragraph 1.2, attachment IX)
Active Medical Device (art.1, paragraph 1.4, attachment IX)
CLASS:
I (Par.3 “Classification”, art.1, paragraph 1.1 Rule 1, attachment IX)
•
Technical reference file Code
RIM-FT001.
•
The evaluation of conformity is developed in reference to article 11 of the 93/42 EEC Directive.
•
The
RIMSA
Quality System conforms to the UNI EN ISO 9001:2000 and UNI EN ISO
13485:2004 regulations and is certified by the IMQ S.p.a. (certified CSQ n.9120.RMS1 and
9124.RMS2).
Name: Paolo Longoni
Position: Managing Director
Summary of Contents for SATURNO WALL
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