IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
COMMITTEE OF TESTING LABORATORIES
IEC 80601-2-30 - Edition 1 + Amendment 1
TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING
R=Required by Lab
S=May be subcontracted
Clause
Measurement/testing
201.11.8.102
Power supply
201.12.1.103
201.12.1.105
Nominal blood pressure indication range
Maximum pressure in single fault condition
201.12.1.106
201.12.1.107
Manometer test mode
Maximum changes of blood presuure
determination
201.15.3.5.101 Shock and vibration for other than transport
Testing / measuring equipment / material needed
NIBP simulator,
stop watch
NIBP simualtor
pressure meter,
stopwatch
stopwatch
patient simulator
Subcontracting
R
R
R
R
R
Shock test in accordance with IEC 60068-2-27:2008 – test type 1, 2
S
Broad-band random vibration test in accordance with IEC 60068-2-64:2008
201.15.3.5.102 Shock and vibration for transport
Shock test in accordance with IEC 60068-2-27:2008 – test type 1, 2
S
Broad-band random vibration test in accordance with IEC 60068-2-64:2008
Free fall in accordance with IEC 60068-2-31:2008 - PROCEDURE 1
201.101.2
Pressurization
mandrel
R
201.104
Maximum inflating time
stopwatch
R
202.6.2.101
Electrosurgery interference recovery
HF surgical equipment test layout according to figure 107,
W
patient simulator accordimg to figure 108,
HF surgical equipment (cut mode with output power of at least 300 W,
coagulation mode with output power of at least 100 W, frequency 450 kHz ±
100 kHz)
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/IEC 17025 regarding validation are applicable, as the tests of this
standard are not standardized tests.
1(1)
2008-05-23