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IEC60601-1 2005 List Apparatus

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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”       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

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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