IEC60601-1 2005 测试设备
TESTING AND MEASURINGEQUIPMENT/ALLOWED SUBCONTRACTING
IEC 60601-1:2005
Medical electrical equipment- Part 1: General requirements for basic safety and essential performance
“R” Required
“S” Maybe subcontracted, see OD 2012
“SPTL” SpecializedFacility, see IECEE 02-2
“W” Witnesstesting in the categories “MED” and “MEAS”
“3PPS” ThreePhase 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
| 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, methylated spirit, isopropyl alcohol (purity not specified: do we need a CTL decision?), 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 (20 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 |
10.4 | Lasers and light emitting diodes (LEDs) | 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 |
