IEC 60601-2-44:2002 pdf download
IEC 60601-2-44:2002 pdf download.Medical electrical equipment -Part 2-44: Particular requirements for the safety ofx-ray equipment for computed tomography.
2.109
TOMOGRAPHIC SECTION THICKNESS
FULL WIDTh AT HALF MAIMUN of the SENSITIVITY PROFILE taken at the iso-centre of a
TOUOGRAPHIC SECTION
2.110
NOMINAt. TOMOGRAPHIC SECTION THICKNESS
in CT SCANNERS the TOMOGRAPHIC SECTION THICKNESS which is selected and indicated on the
CONTROL PANEL
NOTE In heIlc8i acanning the th.ciness 01 a reconatructed image dependB on the helical reconslfuction aIgonthm and pitch, and hence this thickness may not equal the NOMINAL TOIOGRAPNIC SECTION pcxNsss. The Ihickneu ol the reconstructed image may be indicated or selected prIor to the hlical scan.
3 General requirements
This clause of the General Standard applies except as follows:
3.1 Addition.
CT SCANNERS shall be designed so as not to deliver a voltage higher than the NOMINAL X-RAY TUBE VOLTAGE for the X-RAY TUBE ASSEMBLY.
5 ClassificatIon
This clause of the General Standard applies except as follows:
5.1 Replacement:
HIGH VOlTAGE GENERATORS in CT SCANNERS shall be CLASS I EQUIPMENT or INTERNALLY POWERED EQUIPMENT.
5.6 Replacement.
Unless otherwise specified, CT SCANNERS or sub-assemblies thereof shall be classified as suitable for continuous connection to the SUPPLY MAINS in the STAND-BY STATE and for specified LOADINGS; see also 61 m) and 6.8.101.
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on th. outside of EQUIPMENT or EQUIPMENT parts
g) Connection to the supply
Addition:
For CT SCANNERS that are specified to be permanently installed, the information required in 6.1 g) of the General Standard may be stated only In the ACCOMPANYING DOCUMENTS.
m) Mode of operation
Replacement:
The mode of operation — where appropriate, together with maximum permissible ratings — shall be stated in the ACCOMPANYING DOCUMENTS; see 6.8.101.
p) Output
Replacement:
This subclause of the General Standard does not apply.
t) Cooling conditions
Addition:
The cooling requirements for the safe operation of a CT SCANNER, or a sub-assembly thereof, shall be indicated in the ACCOMPANYING DOCUMENTS, including as appropriate the maximum heat dissipation.
6.7 Indicator lights and push-buttons
a) Colours of indicator lights
Addition after the first paragraph:
For CT SCANNERS, the colours to be used for indicator lights shall be as follows:
— the colour green shall be used at the CONTROL PANEL to indicate the state from which one further action leads to the LOADING STATE; see 29.1.101.1 a);
— the colour yellow shall be used at the CONTROL PANEL to indicate the LOADING STATE; see 29.1.101.1 b).
NOTE The colours 01 indicator lights need to be chosen according to the message to be given. Thus, the same operational state of an EQUIPMENT can have simultaneous indications in different colours depending upon the place of indication, for example green at the CONTROL PANEL and red at the entrance to the EXAMINATION ROOM
6.8 ACCOMPANYING DOCUMENTS
6.8.2 INSTRUCTIONS FOR USE
a) General information
Addition:
Electric output data shall be stated in the INSTRUCTIONS FOR USE in terms of LOADING FACTORS as described in 6.8.2 a) 1) to 6.8.2 a) 4).
For CT SCANNERS in which part of the HIGH-VOLTAGE GENERATOR is integrated with the X-RAY TUBE ASSEMBLY (for example X-RAY TUBE HEADS) the stated values shall refer to the complete device.
The following combinations and data shall be stated:
1)The corresponding NOMINAL X-RAY TUBE VOLTAGE together with the highest X-RAY TUBECURRENT obtainable from the HIGH-VOLTAGE GENERATOR when operated at that X-RAY TUBEvOLTAGE.
2)The corresponding highest X-RAY TUBE CURRENT together with the highest X-RAY TUBE
VOLTAGE, obtainable from the HIGH-VOLTAGE GENERATOR when operating at that X-RAY TUBEcURRENT.
3) The corresponding combination of X-RAY TUBE VOLTAGE and X-RAY TUBE CURRENT which
results in the highest electric output power.
4) The NOMINAL ELECTRIC POwER given as the highest constant electric output power in
kilowatts which the HIGH-vOLTAGE GENERATOR can deliver, for a LOADING TIME of 4 s at anX-RAY TUBE VOLTAGE of 120 kV, or if these values are not selectable，with an X-RAY TUBEVOLTAGE nearest to 120 kV and the value of LOADING TIME nearest to but not less than 4 s.The NOMINAL ELECTRIC PowER shall be given together with the combination of X-RAY TUBEVOLTAGE and X-RAY TUBE CURRENT and the LoADING TIME which are used in the CT SCANNER.
