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IEC60601-1 2005 测试设备

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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



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