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

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

  • Model:
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


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