IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
COMMITTEE OF TESTING LABORATORIES
IEC 60601-1 Edition 2(1988)
TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING/ALLOWED WITNESSING
R=Required by Lab
S=May be subcontracted
W = May be witnessed in MTL laboratory, equipment not necessary at CBTL
Clause
4
6
Measurement/testing
Humidity preconditioning
Durability of markings
7
10
Power input
Environmental conditions
15
Supply
Limitations voltage / energy
16
Enclosures and protective covers
17
Defibrillator proof testing
18
19
Earth resistance
Leakage currents
20
21
Dielectric strength test
Mechanical strength
Testing / measuring equipment / material needed
Humidity cabinet
Cloth, distilled water, Isopropyl alcohol and methylated spirit & a
suitable timer / stop watch
Suitable devices for the voltage, current / power and frequency
Climate chamber controlling temperature and humidity or room with
the conditions required
1 phase and 3 phase variacs
Suitable oscilloscope, recorder / set-up or equivalent suitable device
& RCL meter
Pull / push tester, test hook, test finger, test pin
test rods 4 mm / 10 mm (fig. 7-9)
5 kV test circuit & oscilloscope interface circuit according to Figures
50 & 51, oscilloscope
Earth resistance tester
Variac, mV-meter, diverse circuits (fig. 14-27)
Measuring device (fig. 15), alu-foil, isolation transformers (fig. 10-12)
High voltage tester, isolating transformer for HV-tests (fig. 28)
Impact hammer, weights
Hard wood plate
Balance
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Subcontracting
R
R
R
R
R
R
R
R
W
R
R
R
R
R
R
R
IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
Clause
24
25
29
36
37
39
40
41
42
Measurement/testing
Stability tests
Expelled parts
X radiation
EMC requirements
Flammable gases
Common requirements AP and APG
equipment
Requirements AP equipment
Requirements APG equipment
Heating tests
44
Spillage, liquids, sterilisation
45
51
52
Pressure
Hazardous output
Abnormal operation and fault conditions
53
56
Environmental tests
Components
57
Mains part
COMMITTEE OF TESTING LABORATORIES
Testing / measuring equipment / material needed
Inclinometer or trigonometric calculation (slope up to 10 °)
As described per IEC 60065
Radiation meter
EMC; measuring equipment as required in IEC 60601-1-2
See clauses 39 and 40
Voltmeter; test rods 4 mm, 12 mm
Resistance meter according to ISO 471/1853/2878
Voltmeter, Amperemeter, RCL meter, temperature meter
Same equipment as for clause 40 inclusive special gases
Voltmeter, ampere meter (AC / DC)
Temperature indicator / recorder suitable for this function and
thermocouples, test corner
4 wire resistance measuring unit
Measuring cups
Pipette
Humidity chamber
Different liquids for cleaning
IP appliances
Sterilisation to client specification
Sterilisation with steam
Pressure gauges
Voltmeter; amperemeter; oscilloscope
Apparatus for ball pressure test (fig. 48), oven, suitable timer / stop
watch, same equipment as in clause 42
Humidity chamber
Counter; torque tester; weights
IP appliances as per clause 44
Pull tester; different sizes of cables;
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Subcontracting
R
S
W
S
S
R
R
R
R
R
R
R
R
W
W
W
W
R
R
R
R
R
W
R
IEC SYSTEM FOR CONFIRMITY TESTING AND
CERTIFICATION OF ELECTRICAL EQUIPMENT
Clause
59
Appendix F
Measurement/testing
Construction and layout
Flammable mixtures
COMMITTEE OF TESTING LABORATORIES
Testing / measuring equipment / material needed
Winding tester for transformers
Micrometer; sliding calliper
Ball pressure test apparatus (fig. 48); oven
Micrometer; callipers, force gauge, multimeter
Apparatus for rubber ageing in oxygen
See also clause 37 – 40, test apparatus
Subcontracting
R
R
R
R
S
S
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.
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