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IEC 60601-1 Grips And Other Handling Devices-7 Cm Strap Tester

Standard:IEC60601-1-clause 9.4.4Force:0-1500N
Test Time:0-9999sHandle Width:7cm
Highlight:IEC 60601-1-Clause 9.4.4

7cm Strap Tester

1500n Strap Tester

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Product Description

IEC 60601-1Grips and other handling devices-7 cm strap tester
Carrying handles or grips furnished on PORTABLE ME EQUIPMENT shall withstand loading as described in the following test:
The handles and their means of attachment are subjected to a force equal to four times the weight of the ME EQUIPMENT in any direction of NORMAL USE and transport.
If more than one handle is furnished on PORTABLE ME
EQUIPMENT , the force is distributed between the handles. The distribution of forces is determined by measuring the percentage
of the ME EQUIPMENT weight sustained by each handle with the ME
EQUIPMENT in the normal carrying position. If the ME EQUIPMENT is furnished with more than one handle but is so designed that it can readily be carried by only one handle, then each handle is to be
capable of sustaining the total force.
The force is applied uniformly over a 7 cm length of the handle at the centre, starting at zero and gradually increasing so that the test value will be attained in 5 s to 10 s and maintained for a period of 1 min.
Handles that break loose from the ME EQUIPMENT or exhibit any permanent distortion, cracking or other evidence of breakdown constitutes a failure.
IEC 60601-1 Grips And Other Handling Devices-7 Cm Strap Tester 0

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

 

 

ClauseMeasurement/testingTesting / measuring equipment / material neededSubcontracting
4.11Power inputSuitable devices for the voltage, current/power and frequency

Supply: 1 phase and 3 phase variacs

 

R
5.3Ambient temperature, humidity, atmospheric pressureSuitable devices for recording ambient temperature, humidity, atmospheric pressure

 

R
5.7Humidity preconditioning treatmentEnvironmental conditions: Climate chamber controlling temperature and humidity

 

R
5.9.2Accessible partsForce gauge (30 N), standard test finger (figure 6), straight unjointed test finger, test hook (figure 7)

 

R
7.1.2Legibility of markingsIlluminance meter

 

R
7.1.3Durability of markingsDistilled water, ethanol (96% pure), isopropyl alcohol , timer / stop watch

 

R
8.4.2Accessible parts including applied partsOscilloscope, 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 energySuitable oscilloscope recorder /set-up & RCL meterR
8.5.5.1Defibrillation protection5 kV test circuit & oscilloscope interface circuit according to Figures 9 & 10, oscilloscope

 

S
8.5.5.2Energy reduction testThe test circuit according to Figure 11, oscilloscope, oscilloscope leads

 

S
8.6.4Impedance and current-carrying capabilityCurrent source (25 A minimum, 50 or 60 Hz, 6 V maximum)

 

R
8.7Leakage currents and patient auxiliary currentsMeasuring device according to Figure 12, mains isolation transformers, variacs, voltmeter, millivoltmeter, aluminium foil, diverse circuits (fig. 13-20)

 

R
8.8.3Dielectric strengthHigh voltage tester, isolating transformer for HV-tests (fig. 28), stop watch / timer

 

R
8.8.4.1 a)Ball pressure testTest equipment according to IEC 60695-10-2

 

R
8.8.4.2Resistance to environmental stressApparatus for ageing rubber in oxygen

 

S
8.9Creepage distances and air clearancesOscilloscope, oscilloscope leads, callipers, micrometer, spacing gauges, force gauge (2 N & 30 N), standard test finger (figure 6)

 

R
8.9.1.7Material groups classificationTest equipment according to IEC 60112

 

S
8.9.3.4Thermal cyclingHeating cabinet

 

R
8.11.3.5Cord anchorageForce gauge (at least 100 N), torque gauge (at least 0.35 Nm)

 

R
8.11.3.6Cord guardsWeights, angle gauge, radius gauge

 

R
9.4Instability hazards5° & 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
9.5.2Cathode ray tubesThe relevant tests of IEC 60065, Clause 18.

 

S
9.6.2.1Audible acoustic energyA-weighted sound pressure level according to ISO 3746, ISO 9614-1 or IEC 61672-1

 

S
9.6.3Hand-transmitted vibrationMeasurements are made in accordance with ISO 5349-1.

 

S
9.7.5Pressure vesselsHydraulic pressure test apparatus

 

S
9.8Hazards associated with support systemsWeights or load cell, 0.1 m2 test surface, stop watch / timer, human body test mass (Figure 33)

 

R
10.1X-radiationRadiation meter

 

S
10.3Microwave radiationRadiation meter

 

S
10.4LasersTest equipment according to IEC 60825-1S
11.1Excessive temperaturesTemperature indicator/recorder suitable for this function and

thermocouples, 4 wire resistance unit, test corner, variac

 

R
11.2Fire preventionSpark ignition test apparatus (Figure 34), oxygen gas analyzer

 

S
11.3Constructional requirements for fire enclosuresFV tests specified in IEC 60695-11-10S
11.6.2Overflow15° inclined plane or inclinometer or trigonometric calculation, stop watch / timer, high voltage tester

 

R
11.6.3SpillageFlask or graduated cylinder, stop watch / timer

 

R
11.6.5Ingress of water or particulate matterClassification tests of IEC 60529

 

W
11.6.6Cleaning and disinfectionDielectric strength and leakage current tests as appropriate

 

R
11.6.7SterilizationSterilisation to client specification

 

S
13Hazardous situations and fault conditionsstop watch / timer, voltmeter, ammeter, temperature indicator / recorder suitable for this function and thermocouples, 4 wire resistance unit, cheesecloth

 

R
15.3Mechanical strengthForce 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
15.4.2Temperature and overload control devicesPositive temperature coefficient devices (PTC’s) with IEC 60730-1: 1999, clauses 15, 17, J.15 and J.17

 

S
15.4.3.4Primary Lithium batteriesPerformance of the tests identified in IEC 60086-4

 

S
15.4.3.4Secondary Lithium batteriesPerformance of the tests identified in IEC 62133S
15.4.6Actuating parts of controlsForce gauge (at least 100 N), torque gauge (at least 6 Nm), stop watch / timer

 

R
15.4.7Cord-connected hand-held and foot-operated control devicesForce gauge (minimum1 350 N), 30 mm diameter test tool, stop watch / timer

 

R
15.4.7.3Entry of liquidsClassification tests of IEC 60529

 

W
15.5.1.1TransformersWinding tester for transformers, temperature indicator/recorder suitable for this function and thermocouples variac, loads

 

R
15.5.2Dielectric strength5x voltage / 5x frequency dielectric strength test fixture, stop watch / timer

 

R
16.6Leakage currentsAs in sub-clause 8.7

 

R
A 10.4Light emitting diodes (LEDs)As specified in IEC 62471

 

S
GProtection against hazards of ignition of flammable anaesthetic mixtures4 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.4.3Prevention of electrostatic chargesantistatic material testing according to ISO 2882

 

S
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

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