Acteon X-MIND trium - List of International Standards and Directives; Dosimetric Indications

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USER MANUAL• X-Mind trium • (13) • 03/2018 • NTR0EN010M
11.15 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
The system is classied as:
Directive MDD 93/42 EEC
Annex IX, article 10
21CFR
892.1750
SOR 98/282
rule 8
TG(MD) Regulations 2002
Schedule 2 part 4.3
Pharmaceuticals and
Medical Devices Act
[Table 1]
Class IIb II III IIb II
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
21 CFR 1020.30
21 CFR 1020.31
21 CFR 1020.33
11.16 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 benecial 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.