93
17.6. EQUIPMENT TESTED ACCORDING STANDARDS
EN 60601-1 (1990);
Amendment 1 EN 60601-1 (1992);
Amendment 2 EN 60601-1 (1995);
Amendment13 EN 60601-1 (1995);
UL 60601-
60601-1-4-2004
EN 60601-1-3 (2001);
EN 60601-2-7 (2001);
EN 60601-2-28 (2001);
EN 60601-2-32 (2001);
IEC 60601-1;
Emenda 1 IEC 601-1;
IEC 60601-1-2;
CISPR 11, edição 3.1 (1999);
IEC 61000-4-2 (1999);
IEC 61000-4-3 (1998);
IEC 61000-4-4 (1995);
IEC 61000-4-5 (1995);
IEC 61000-4-6 (1996);
IEC 61000-4-11 (1996);
IEC series 60601-1 Medical Electrical Equipment - Part 1: General requirements for safety;
EN 980:2003 (Ed. 2) - Graphical symbols for use in the labeling of medical devices;
ISO 14971 - Medical devices - application of risk management medical devices;
ISO 9687: 1993 - Dental equipment - graphical symbols;
ISO 7494 - Norma dental units;
ISO 13485-2 - Quality systems - medical devices;
ISO 780 - Packaging - pictorial marking for handling goods;
ISO 11144 - Norma dental equipment - connections for supply and waste lines.
Reference axis between the target angle and the focal point of the X-ray tube:
90º With axis of anode and cathode, respective
Target angle with reference axis:
5º
Reference axis angle between the target and the focal point of the x-ray generator
mounted
:
measurements of x-ray generator mounted:
318mm x 440mm x 212mm
weight of X-ray generator mounted:
34.6 lb.
Tolerances of the focal point in relation in relation to the axes of reference:
X=
0.5mm (lateral)
Y=
0.5mm (depth)
Z=
0.5mm (height)
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