11.14 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
MDD 93/42 EEC and subsequent amendments
In compliance with the classication indicated in the Medical Device Directive 93/42/EEC, Annex IX, article 10: “Active devices
intended to emit ionising radiation and intended for diagnostic radiology”, the system is classied as:
Class IIb
IEC/EN 60601-1:1988, 2nd edition
IEC 60601-1/A1
IEC 60601-1/A2
CSA C22.2#601.1-M90 including update 2
UL 60601-1 : 2003, 1st edition
AS/NZS 3200.1.0
JIST 0601-1: 1999
IEC/EN 60601-1-1:2000, 2nd edition
IEC/EN 60601-1-3:1994, 1st edition
IEC/EN 60601-1-4:1996, 1st edition
IEC 60601-1-4/A1
IEC/EN 60601-2-7:1998, 2nd edition
IEC/EN 60601-2-28:1993, 1st edition
IEC/EN 60601-2-32:1994, 1st edition
IEC/EN 60601-2-44:2001, 2nd edition
IEC 60601-2-44/A1(including corr. 1: 2006)
IEC/EN 60601-1:2005, 3nd edition
IEC/EN 60601-1-3:2008,
IEC/EN 60601-1-6:2010,
IEC 62366: 2007
IEC 60601-2-63:2012
ANSI/AAMI ES60601-1:2005
CAN/CSA-C222.2 N. 60601-1:08
IEC/EN 60601-2: 2007
11.15 DOSIMETRIC INDICATIONS
The following tables provides dosimetric indications related to the execution of radiographic exams by the X-MIND trium.
The radiation dose is reported in terms of Dose Area Product (DAP), which takes into account the size of the X-ray beam and
its intensity, providing a thorough dose index; in detail, the DAP is computed by multiplying the Air Kerma measured by the
X-ray beam area at the measurement location.
The DAP is considered benecial for the following reasons:
· It is dependent by the typology of beam limiting device installed and in use
· It is independent by the measured location, that is the distance from the focal spot
This section reports the value of radiation dose for every type of exam and any combination of loading factors.
Typically, these dosimetric indications represents a reference for the operators to adjust or modify the loading factors during
the process of optimization of the scanning protocol; in addition, these values might be used for dosimetric check during
installation or periodic maintenance to assess the proper functioning of the device.
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