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IEC 60601-1-Figure 34 Spark Ignition Test Apparatus

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China KingPo Technology Development Limited certification
China KingPo Technology Development Limited certification
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According to SGS Qualified Suppliers requirements. kingpo is granted as "STATEMENT OF SGS QUALIFED SUPPLIERS"

—— SGS

Good day and thank you for you According to the sample of the instrument you provided, we are very satisfied with our test. We want to change the order from 2 to 10. The following is the order details of our Asia Pacific branch. Would you please send me the quotation of the corresponding office? So we can generate an order to confirm it. Thank you.

—— Angel

Dear Supplier KINGPO TECHNOLOGY DEVELOPEMENT, In the ambit of ISO 9001:2015 certification, we intend to communicate the requirements as well as its percentage used on final evaluation used by ISQ to control and monitor its external supplier’s performance as per bellow: According with the above requirements to be maintained in future evaluations

—— ISQ Procurement Management

first of all, I would also like to thank you for the good cooperation! We especially appreciate the fast service and that there is almost always a solution for our requests and problems. Thank you very much for this and all the best and continue a good cooperation also for 2022!

—— TUV Rheinland Germany

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IEC 60601-1-Figure 34 Spark Ignition Test Apparatus

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

Large Image :  IEC 60601-1-Figure 34 Spark Ignition Test Apparatus

Product Details:
Place of Origin: China
Brand Name: KingPo
Certification: calibration cert
Model Number: IEC 60601-1-Figure 34
Payment & Shipping Terms:
Minimum Order Quantity: 1
Packaging Details: safety carton pack or plywood box
Payment Terms: T/T
Detailed Product Description
Standard: IEC 60601-1-Figure 34 Pin Diameter: 3mm And 1mm
Oxygen Speed: 0.5 M/s Times: 300 Min
High Light:

IEC 60601-1-Figure 34

,

3mm Pin Spark Ignition Test Apparatus

,

1mm Pin Spark Ignition Test Apparatus

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
the RISK MANAGEMENT FILE .
As an alternative to 11.2.2.1 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

 

 

 

TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING

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

 

 

Clause Measurement/testing Testing / measuring equipment / material needed Subcontracting
4.11 Power input

Suitable devices for the 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 (minimum1 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, ether/oxygen mixture (ether 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 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
 
     

 

 

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