TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING
IEC 60601-1:2005+AMD1:2012+AMD2:2020
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
Download IEC 60601-1-2020
| Clause | Measurement/testing | Testing / measuring equipment / material needed | Equipment |
| 4.11 | Power input | Suitable devices for the voltage, current/power and frequency
Supply: 1 phase and 3 phase variacs |
IEC 60601-1-2020 |
| 5.3 | Ambient temperature, humidity, atmospheric pressure | Suitable devices for recording ambient temperature, humidity, atmospheric pressure | |
| 5.7 | Humidity preconditioning treatment | Environmental conditions: Climate chamber controlling temperature and humidity | |
| 5.9.2 | Accessible parts | Force gauge (30 N), standard test finger (figure 6), straight unjointed test finger, test hook (figure 7) | |
| 7.1.2 | Legibility of markings | Illuminance meter | |
| 7.1.3 | Durability of markings | Distilled water, ethanol (96% pure), isopropyl alcohol, timer/stopwatch | |
| 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)
10kOhm/8W resistor |
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| 8.4.3, 8.4.4 | Limitations voltage and energy | Suitable oscilloscope recorder /set-up & RCL meter | |
| 8.5.4 | Working voltage measurement | Oscilloscope, High voltage differential probe | |
| 8.5.5.1 | Defibrillation protection | 5 kV test circuit & oscilloscope interface circuit according to Figures 9 & 10, oscilloscope | |
| 8.5.5.2 | Energy reduction test | The test circuit according to Figure 11, oscilloscope, oscilloscope leads | |
| 8.6.4 | Impedance and current-carrying capability | Current source (25 A minimum, 50 or 60 Hz, 6 V maximum) | |
| 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) | |
| 8.8.3 | Dielectric strength | High voltage tester, isolating transformer for HV-tests (fig. 28), stopwatch /timer | |
| 8.8.4.1 a) | Ball pressure test | Test equipment according to IEC 60695-10-2 | |
| 8.8.4.2 | Resistance to environmental stress | Apparatus for ageing rubber in oxygen
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| 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) | |
| 8.9.1.7 | Material groups classification | Tracking Tester | |
| 8.9.3.4 | Thermal cycling | Heating cabinet | |
| 8.11.3.5 | Cord anchorage | Force gauge (at least 100 N), torque gauge (at least 0.35 Nm)
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| 8.11.3.6 | Cord guards | Weights, angle gauge, radius gauge | |
| 9.2.3.2 | Overtravel end stops | The moving part is to be driven against each end stop or other mechanical means for the number of cycles, operating speed and test conditions as specified in Table 33. | |
| 9.4 | Instability hazards | 5° & 10° inclined planes or inclinometer or trigonometric calculation, force gauge (no more than 150 N), 20 cm by 20 cm test surface, weights, test threshold (10 mm high and 80 mm wide), 7 cm strap, stopwatch / timer | |
| 9.5.2 | Cathode ray tubes | The relevant tests of IEC 60065, Clause 18 or IEC 61965 | |
| 9.6.2.1 | Audible acoustic energy | A-weighted sound pressure level according to ISO 3746, ISO 9614-1 or IEC 61672-1 | |
| 9.6.3 | Hand-transmitted vibration | Measurements are made in accordance with ISO 5349-1 | |
| 9.7.5 | Pressure vessels | Hydraulic pressure test apparatus, stopwatch / timer | |
| 9.8 | Hazards associated with support systems | Weights or load cell, 0.1 m2 test surface, stopwatch / timer, human body test mass (Figure 33) | |
| 10.1 | X-radiation | Radiation meter | |
| 10.3 | Microwave radiation | Radiation meter | |
| 10.4 | Lasers | Test equipment according to IEC 60825-1 | |
| 11.1 | Excessive temperatures | Temperature indicator/recorder suitable for this function and
thermocouples, 4 wire resistance unit, test corner, variac |
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| 11.2 | Fire prevention | Spark ignition test apparatus (Figure 34), oxygen gas analyzer | |
| 11.3 | Constructional requirements for fire enclosures | FV tests specified in IEC 60695-11-10 | |
| 11.6.2 | Overflow | 15° inclined plane or inclinometer or trigonometric calculation, stop watch / timer, high voltage tester | |
| 11.6.3 | Spillage | Flask or graduated cylinder, stop watch / timer | |
| 11.6.5 | Ingress of water or particulate matter | Classification tests of IEC 60529 | |
| 11.6.6 | Cleaning and disinfection | Dielectric strength and leakage current tests as appropriate | |
| 11.6.7 | Sterilization | Sterilisation to client specification | |
| 11.7 | Biocompatibility | Test instruments comply with ISO 10993 series of standards | |
| 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 | |
| 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 | |
| 15.4.2 | Temperature and overload control devices | Positive temperature coefficient devices (PTC’s) with IEC 60730-1: 2010, clauses 15, 17, J.15 and J.17 | |
| 15.4.3.4 | Primary Lithium batteries | Performance of the tests identified in IEC 60086-4 | |
| 15.4.3.4 | Secondary Lithium batteries | Performance of the tests identified in IEC 62133 | |
| 15.4.6 | Actuating parts of controls | Force gauge (at least 100 N), torque gauge (at least 6 Nm), stop watch / timer | |
| 15.4.7 | Cord-connected hand-held and foot-operated control devices | Force gauge (minimum1 350 N), 30 mm diameter test tool, stop watch / timer | |
| 15.4.7.3 | Entry of liquids | Classification tests of IEC 60529 | |
| 15.5.1.1 | Transformers | Winding tester for transformers, temperature indicator/recorder suitable for this function and thermocouples variac, loads | |
| 15.5.2 | Dielectric strength | 5x voltage / 5x frequency dielectric strength test fixture, stop watch / timer | |
| 16.6 | Leakage currents | As in sub-clause 8.7 | |
| A 10.4 | Light emitting diodes (LEDs) | As specified in IEC 62471 | |
| 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, ether/oxygen mixture (ether volume percentage 12,2 % ± 0,4 %), test apparatus for flammable mixtures (Figure G.7), | |
| G.4.3 | Prevention of electrostatic charges | antistatic material testing according to ISO 2882 | |
| L | Insulated winding wires for use without interleaved insulation | Sample is 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. |
