IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
COMMITTEE OF TESTING LABORATORIES
IEC 60601-2-45 Edition 3
TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING
R=Required by Lab
S=May be subcontracted
Clause
203.6.7.102
203.8.5.4.102.5.
201.8.8.3
Measurement/testing
Motion of anti-scatter grid
Dielectric strength
201.9.2.3.1
203.6.7.103.2
Unintended movement
ARTEFACTS from grid lines
203.6.7.104.2
Maximum LOADING TIME
203.8.5.4.102.6
Compression force
201.9.2.101.3 Biopsy needle positioning accuracy
Testing / measuring equipment / material needed
- Adequate Sand-filled bags or soft rubber blocks
- Aluminium plate of 2mm thickness
- Densitometer (Range 0 to 3,5)
- Required using of memory scope with measurement
functions
- High voltage dividers or kV meter
- Force gauge
- PHANTOM of 20 mm PMMA
- aluminium plate of 2 mm thicknesswith sufficient
dimensions
- densitometer
- 40 mm thick rectangular Polymethylmethacrylate (PMMA)
PHANTOM with sides equal to or exceeding 150 mm.
- Compression scale
- soft rubber block 20 mm to 50 mm thick, and 100 mm to 120 mm
long and wide
- Test device for mammographic stereotactic devices
1(3)
Subcontracting
W
W
R
W
W
W
S
IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
Clause
Measurement/testing
COMMITTEE OF TESTING LABORATORIES
Testing / measuring equipment / material needed
- Dynamometer
- Adequate ion chamber associated to Electrometer-source/
or adequate Radiation dosimeter.
- Adequate ion chamber associated to Electrometer-source/
Test for Half-value layer
or adequate Radiation dosimeter.
- Aluminium filters (Purity >= 99,99%)
- Adequate ion chamber associated to Electrometer-source/
Primary protective shielding
or adequate Radiation dosimeter.
- Fit shielding of ion chamber
Protective barrier
- Adequate X-ray generator (35kV; percentage ripple <=4%;
Total filtration of 0,03mmMo)
Reproducibility of radiation output - Adequate ion chamber associated to Electrometer-source/
without AEC actived
or adequate Radiation dosimeter. ( High sensibility)
Linearity and constancy
- Same equipment than above
Accuracy and reproducibility of X-ray - Required using of memory scope with measurement
functions
tube
- High voltage dividers or kV meter
voltage
- Required using of memory scope with measurement
Accuracy of X-ray tube current
functions
- Set of precision resistors
- Differential amplifier
AEC requirements
- Appropriate phantom
Subcontracting
Stability in normal use
Radiation output
203.10.1
203.7.6
203.11.101
203.13.101
203.6.4.3.102.2
203.6.4.3.102.3
203.6.5.2
Accuracy of Irradiation time
- Required using of memory scope with measurement
functions
- High voltage dividers or kV meter
2(3)
W
W
W
W
W
W
W
IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
Clause
Measurement/testing
Accuracy of Current time product
COMMITTEE OF TESTING LABORATORIES
Testing / measuring equipment / material needed
- Required using of memory scope with measurement
functions
- High voltage dividers or kV meter
- Set of precision resistors
- Differential amplifier
Subcontracting
Note: The presence of equipment alone does not indicate a satisfactory situation. Assessors must evaluate the equipment design, calibration, uncertainty and
documentation to ensure compliance with the directions of the standard. The requirements of ISO Guide 17025 regarding validation are applicable, as the tests of this
standard are not standardised tests.
3(3)