IEC 60601-1-Figure 34 Spark Ignition Test Apparatus

IEC 60601-1-Figure 34 Spark Ignition Test Apparatus

  • Model:
11 .2.2 M E EQUIPMENT and ME SYSTEMS used in conjunction with OXYGEN RICH ENVIRONMENT
11 .2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENT
In ME EQUIPMENT and ME SYSTEMS , the RISK of fire in an OXYGEN RICH ENVIRONMENT shall be reduced as far as possible under NORMAL CONDITION or SINGLE FAULT CONDITIONS (as identified in 11 .2.3). An unacceptable RISK of fire is considered to exist in an OXYGEN RICH ENVIRONMENT when a source of ignition is in contact with ignitable material and there is no means that would limit the spread of a fire.
NOTE 1 For oxygen concentrations up to 25 % at one atmosphere or partial pressures up to 27,5 kPa for higher atmospheric pressures, the requirements in 1 3.1 .1 are considered to be sufficient.

a) * A source of ignition is considered to exist in an OXYGEN RICH ENVIRONMENT when any of the following conditions exist in NORMAL CONDITION and SINGLE FAULT CONDITIONS (including voltage and current):
1 ) the temperature of the material is raised to its ignition temperature;
2) temperatures could affect solder or solder joints causing loosening, short circuiting or other failures that could result in sparking or raising the temperature of the material to its ignition temperature;
3) parts affecting safety crack or change their outer shape exposing temperatures exceeding 300 °C or sparks (see 4) and 5) below) due to overheating;
4) temperatures of parts or components could exceed 300 °C;
5) sparks provide adequate energy for ignition by exceeding the limits of Figure 35 to Figure 37 (inclusive).

Items 4) and 5) address the worst case where the atmosphere is 1 00 % oxygen, the contact material (for item 5) is solder and the fuel is cotton. Available fuels and oxygen concentrations should be taken into consideration when applying these specific requirements. Where deviations from these worst case limits are made (based on lower oxygen concentrations or less flammable fuels) they shall be justified and documented in
As an alternative to a) 5), the following test may be used to determine whether a source of ignition exists.

First, the place(s) within the ME EQUIPMENT where sparking might cause ignition are identified. Then the material(s) of the parts between which sparks can occur is identified.
Samples of the same material are then used to construct the contact pins for the test apparatus (see Figure 34).
Other parameters for the test are: oxygen concentration, fuel, electrical parameters (current, voltage, capacitance, inductance or resistance). These parameters are chosen such that they represent the worst case for the ME EQUIPMENT

Two contact pins made of the material to be considered are placed in opposition (see Figure 34). One pin has a diameter of 1 mm, the other of 3 mm. The electrical source is connected to the pins as shown in Figure 35 to Figure 37. A piece of cotton is placed close to the contact surfaces of the two pins. The contacts are constantly flushed by oxygen with a speed of less than 0,5 m/s via a tube. The cathode is moved to the anode to close the contacts and pulled back to open them again. A minimum of 300 trials has to be performed before it can be decided that the sparks do not ignite. If the sparks get smaller because of bad surfaces of the electrodes, the electrodes are cleaned with a file. If the cotton gets
black because it became oxidized then it is replaced. In Figure 36 and Figure 37, the resistance used to control current flowing into the inductor and the time constant for charging the capacitor is chosen such that it has minimal impact on the energy of the spark. This is tested by visual inspection without the capacitor in place or with the inductor shorted.

The situation with the highest voltage or current respectively and no ignition defines the upper limit. A safe upper limit is given by dividing the upper limit of voltage or current respectively with the safety margin factor of three.

IEC 60601-1-Figure 34 Spark Ignition Test Apparatus 0

Figure 34 – Spark ignition test apparatus

IEC 60601-1-Figure 34 Spark Ignition Test Apparatus 1

Figure 35 – Maximum allowable current I as a function of the maximum allowable voltage U measured in a purely resistive circuit in an OXYGEN RICH ENVIRONMENT

IEC 60601-1-Figure 34 Spark Ignition Test Apparatus 2

Figure 36 – Maximum allowable voltage U as a function of the capacitance C measured in a capacitive circuit used in an OXYGEN RICH ENVIRONMENT

IEC 60601-1-Figure 34 Spark Ignition Test Apparatus 3

Figure 37 – Maximum allowable current I as a function of the inductance L measured in an inductive circuit in an OXYGEN RICH ENVIRONMENT


IEC 60601-1:2005 + Am.1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

“R” Required

“S” May be subcontracted, see OD 2012

“SPTL” Specialized Facility, see IECEE 02-2

“W” Witness testing in the categories “MED” and “MEAS”

“3PPS” Three Phase Power Supply required

ClauseMeasurement/testingTesting / measuring equipment / material neededSubcontracting
4.11Power input

Suitable devices for the voltage, current/power and frequency

Supply: 1 phase and 3 phase variacs

5.3Ambient temperature, humidity, atmospheric pressure

Suitable devices for recording ambient temperature, humidity, atmospheric pressure

5.7Humidity preconditioning treatment

Environmental conditions: Climate chamber controlling temperature and humidity

5.9.2Accessible parts

Force gauge (30 N), standard test finger (figure 6), straight unjointed test finger, test hook (figure 7)

7.1.2Legibility of markings

Illuminance meter

7.1.3Durability of markings

Distilled water, ethanol (96% pure), isopropyl alcohol , timer / stop watch

8.4.2Accessible 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)




Limitations voltage and energySuitable oscilloscope recorder /set-up & RCL meterR protection

5 kV test circuit & oscilloscope interface circuit according to Figures 9 & 10, oscilloscope

S reduction test

The test circuit according to Figure 11, oscilloscope, oscilloscope leads

8.6.4Impedance and current-carrying capability

Current source (25 A minimum, 50 or 60 Hz, 6 V maximum)

8.7Leakage currents and patient auxiliary currents

Measuring device according to Figure 12, mains isolation transformers, variacs, voltmeter, millivoltmeter, aluminium foil, diverse circuits (fig. 13-20)

8.8.3Dielectric strength

High voltage tester, isolating transformer for HV-tests (fig. 28), stop watch / timer

R a)Ball pressure test

Test equipment according to IEC 60695-10-2

R to environmental stress

Apparatus for ageing rubber in oxygen

8.9Creepage distances and air clearances

Oscilloscope, oscilloscope leads, callipers, micrometer, spacing gauges, force gauge (2 N & 30 N), standard test finger (figure 6)

R groups classification

Test equipment according to IEC 60112

S cycling

Heating cabinet

R anchorage

Force gauge (at least 100 N), torque gauge (at least 0.35 Nm)

R guards

Weights, angle gauge, radius gauge

9.4Instability 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

9.5.2Cathode ray tubes

The relevant tests of IEC 60065, Clause 18.

S acoustic energy

A-weighted sound pressure level according to ISO 3746, ISO 9614-1 or IEC 61672-1

9.6.3Hand-transmitted vibration

Measurements are made in accordance with ISO 5349-1.

9.7.5Pressure vessels

Hydraulic pressure test apparatus

9.8Hazards associated with support systems

Weights or load cell, 0.1 m2 test surface, stop watch / timer, human body test mass (Figure 33)


Radiation meter

10.3Microwave radiation

Radiation meter

10.4LasersTest equipment according to IEC 60825-1S
11.1Excessive temperatures

Temperature indicator/recorder suitable for this function and

thermocouples, 4 wire resistance unit, test corner, variac

11.2Fire prevention

Spark ignition test apparatus (Figure 34), oxygen gas analyzer

11.3Constructional requirements for fire enclosuresFV tests specified in IEC 60695-11-10S

15° inclined plane or inclinometer or trigonometric calculation, stop watch / timer, high voltage tester


Flask or graduated cylinder, stop watch / timer

11.6.5Ingress of water or particulate matter

Classification tests of IEC 60529

11.6.6Cleaning and disinfection

Dielectric strength and leakage current tests as appropriate


Sterilisation to client specification

13Hazardous situations and fault conditions

stop watch / timer, voltmeter, ammeter, temperature indicator / recorder suitable for this function and thermocouples, 4 wire resistance unit, cheesecloth

15.3Mechanical 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

15.4.2Temperature and overload control devices

Positive temperature coefficient devices (PTC’s) with IEC 60730-1: 1999, clauses 15, 17, J.15 and J.17

S Lithium batteries

Performance of the tests identified in IEC 60086-4

S Lithium batteriesPerformance of the tests identified in IEC 62133S
15.4.6Actuating parts of controls

Force gauge (at least 100 N), torque gauge (at least 6 Nm), stop watch / timer

15.4.7Cord-connected hand-held and foot-operated control devices

Force gauge (minimum1 350 N), 30 mm diameter test tool, stop watch / timer

R of liquids

Classification tests of IEC 60529


Winding tester for transformers, temperature indicator/recorder suitable for this function and thermocouples variac, loads

15.5.2Dielectric strength

5x voltage / 5x frequency dielectric strength test fixture, stop watch / timer

16.6Leakage currents

As in sub-clause 8.7

A 10.4Light emitting diodes (LEDs)

As specified in IEC 62471

GProtection 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.4.3Prevention of electrostatic charges

antistatic material testing according to ISO 2882

LInsulated winding wires for use without interleaved insulationSample 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.S