IEC 60601-1 Grips 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.

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, vol/oxygen mixture (vol 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