| 4.11 |
Power input |
Suitable devices for voltage, current/power and frequency supply: 1 phase and 3 phase variacs |
R |
| 5.3 |
Ambient temperature, humidity, atmospheric pressure |
Suitable devices for recording ambient temperature, humidity, atmospheric pressure |
R |
| 5.7 |
Humidity preconditioning treatment |
Environmental conditions: Climate chamber controlling temperature and humidity |
R |
| 5.9.2 |
Accessible parts |
Force gauge (30 N), standard test finger (figure 6), straight unjointed test finger, test hook (figure 7) |
R |
| 7.1.2 |
Legibility of markings |
Illuminance meter |
R |
| 7.1.3 |
Durability of markings |
Distilled water, ethanol (96% pure), isopropyl alcohol, timer/stop watch |
R |
| 8.4.2 |
Accessible parts including applied parts |
Oscilloscope, oscilloscope leads, suitable instruments for measuring voltage, current, capacitance, test pin (Figure 8), metal test rod (D = 4 mm, L = 100 mm), force gauge (10 N) |
R |
| 8.4.3, 8.4.4 |
Limitations voltage and energy |
Suitable oscilloscope recorder/set-up & RCL meter |
R |
| 8.5.5.1 |
Defibrillation protection |
5 kV test circuit & oscilloscope interface circuit according to Figures 9 & 10, oscilloscope |
S |
| 8.5.5.2 |
Energy reduction test |
The test circuit according to Figure 11, oscilloscope, oscilloscope leads |
S |
| 8.6.4 |
Impedance and current-carrying capability |
Current source (25 A minimum, 50 or 60 Hz, 6 V maximum) |
R |
| 8.7 |
Leakage currents and patient auxiliary currents |
Measuring device according to Figure 12, mains isolation transformers, variacs, voltmeter, millivoltmeter, aluminium foil, diverse circuits (fig. 13-20) |
R |
| 8.8.3 |
Dielectric strength |
High voltage tester, isolating transformer for HV-tests (fig. 28), stop watch/timer |
R |
| 8.8.4.1 a) |
Ball pressure test |
Test equipment according to IEC 60695-10-2 |
R |
| 8.8.4.2 |
Resistance to environmental stress |
Apparatus for ageing rubber in oxygen |
S |
| 8.9 |
Creepage distances and air clearances |
Oscilloscope, oscilloscope leads, callipers, micrometer, spacing gauges, force gauge (2 N & 30 N), standard test finger (figure 6) |
R |
| 8.9.1.7 |
Material groups classification |
Test equipment according to IEC 60112 |
S |
| 8.9.3.4 |
Thermal cycling |
Heating cabinet |
R |
| 8.11.3.5 |
Cord anchorage |
Force gauge (at least 100 N), torque gauge (at least 0.35 Nm) |
R |
| 8.11.3.6 |
Cord guards |
Weights, angle gauge, radius gauge |
R |
| 9.4 |
Instability hazards |
5° & 10° inclined planes or inclinometer or trigonometric calculation, force gauge (at least 220 N), 20 cm by 20 cm test surface, weights, test threshold (10 mm high and 80 mm wide), 7 cm strap, stop watch/timer |
R |
| 9.5.2 |
Cathode ray tubes |
The relevant tests of IEC 60065, Clause 18. |
S |
| 9.6.2.1 |
Audible acoustic energy |
A-weighted sound pressure level according to ISO 3746, ISO 9614-1 or IEC 61672-1 |
S |
| 9.6.3 |
Hand-transmitted vibration |
Measurements are made in accordance with ISO 5349-1. |
S |
| 9.7.5 |
Pressure vessels |
Hydraulic pressure test apparatus |
S |
| 9.8 |
Hazards associated with support systems |
Weights or load cell, 0.1 m2 test surface, stop watch/timer, human body test mass (Figure 33) |
R |
| 10.1 |
X-radiation |
Radiation meter |
S |
| 10.3 |
Microwave radiation |
Radiation meter |
S |
| 10.4 |
Lasers |
Test equipment according to IEC 60825-1 |
S |
| 11.1 |
Excessive temperatures |
Temperature indicator/recorder suitable for this function and thermocouples, 4 wire resistance unit, test corner, variac |
R |
| 11.2 |
Fire prevention |
Spark ignition test apparatus (Figure 34), oxygen gas analyzer |
S |
| 11.3 |
Constructional requirements for fire enclosures |
FV tests specified in IEC 60695-11-10 |
S |
| 11.6.2 |
Overflow |
15° inclined plane or inclinometer or trigonometric calculation, stop watch/timer, high voltage tester |
R |
| 11.6.3 |
Spillage |
Flask or graduated cylinder, stop watch/timer |
R |
| 11.6.5 |
Ingress of water or particulate matter |
Classification tests of IEC 60529 |
W |
| 11.6.6 |
Cleaning and disinfection |
Dielectric strength and leakage current tests as appropriate |
R |
| 11.6.7 |
Sterilization |
Sterilisation to client specification |
S |
| 13 |
Hazardous situations and fault conditions |
Stop watch/timer, voltmeter, ammeter, temperature indicator/recorder suitable for this function and thermocouples, 4 wire resistance unit, cheesecloth |
R |
| 15.3 |
Mechanical strength |
Force gauge (250 N minimum), circular plane surface 30 mm in diameter, 500 g steel ball, 50 mm thick hardwood board (hardwood > 600 kg/m3), 40 mm step, hardwood doorframe (40 mm2), circulating air oven |
R |
| 15.4.2 |
Temperature and overload control devices |
Positive temperature coefficient devices (PTC's) with IEC 60730-1: 1999, clauses 15, 17, J.15 and J.17 |
S |
| 15.4.3.4 |
Primary Lithium batteries |
Performance of the tests identified in IEC 60086-4 |
S |
| 15.4.3.4 |
Secondary Lithium batteries |
Performance of the tests identified in IEC 62133 |
S |
| 15.4.6 |
Actuating parts of controls |
Force gauge (at least 100 N), torque gauge (at least 6 Nm), stop watch/timer |
R |
| 15.4.7 |
Cord-connected hand-held and foot-operated control devices |
Force gauge (minimum 1,350 N), 30 mm diameter test tool, stop watch/timer |
R |
| 15.4.7.3 |
Entry of liquids |
Classification tests of IEC 60529 |
W |
| 15.5.1.1 |
Transformers |
Winding tester for transformers, temperature indicator/recorder suitable for this function and thermocouples variac, loads |
R |
| 15.5.2 |
Dielectric strength |
5x voltage / 5x frequency dielectric strength test fixture, stop watch/timer |
R |
| 16.6 |
Leakage currents |
As in sub-clause 8.7 |
R |
| A 10.4 |
Light emitting diodes (LEDs) |
As specified in IEC 62471 |
S |
| G |
Protection against hazards of ignition of flammable anaesthetic mixtures |
4 mm & 12 mm diameter test rods, timer/stop watch, gasket test B-b of IEC 60068-2-2, force gauge (minimum 100 N), gas pressure meter (0 to 400 Pa range), voltmeter, ammeter, ohmmeter, meter for capacitance and inductance, oxygen mixture (volume percentage 12.2% ± 0.4%), test apparatus for flammable mixtures (Figure G.7) |
S |
| G.4.3 |
Prevention of electrostatic charges |
Antistatic material testing according to ISO 2882 |
S |
| L |
Insulated winding wires for use without interleaved insulation |
Sample preparation according to IEC 60851-5:1996 & dielectric according to 60601-1; flexibility and adherence test 8 of IEC 60851-3:1996; mandrels of diameters according to Table L.1; heat shock test 9 of IEC 60851-6:1996; 2 mm diameter shot of stainless steel, nickel or nickel plated iron |
S |