Service  » Update Service » Amendments to DIN VDE 0751:2001
GMC-I Service GmbH - Gebäude

GMC-I Service GmbH
Thomas-Mann-Str. 16-20
D-90471 Nürnberg
Fon: +49 911 817718 - 0
Fax: +49 911 817718 - 253

 

How to find us

 

Opening times
Mon-Thu from 06.30-16.30 clock
Fri 06.30-14.00 clock

Comparison: DIN VDE 0751 October 1990 versus October 2001

October 1990

October 2001

Repair, modification and testing of medical and electrical devices Periodic testing and testing prior to initial start-up for electrical medical devices and systems
Can also be used for testing after repair and/or modification
Valid through October 2003 Valid as of October 2001
Testing may only be performed by trained personnel. Testing may only be performed by electricians or under their supervision
Systems testing
The first measured value for new instruments must be ascertained and documented in writing as a comparative value for future measurements. Testing prior to initial start-up – the first measured value and the measuring method must be documented.
The measured value for leakage current may not deviated from the first measured value by more than 50% or 10 µA (whichever is larger). Periodic testing – measured values and measuring methods must be documented. If the measured value is more than 90% of the allowable limit value, the first measured value must be used for evaluation. If no first measured values are available, testing intervals can be shortened.
Testing after repair depends upon the type of work executed (same tests as for testing prior to initial start-up and periodic testing ).
Accessories used together with the instrument and/or disposable items are evaluated during visual inspection.
Protective conductor resistance
Test current > 5 A / 4 to 6V AC or DC
Limit values: 0.2 ohm, conductor: 0.1 ohm

Permanently installed: 0.2 ohm (without cable)
Protective conductor resistance
Test current > 200 mA / 4 to 24 V AC or DC (plus and minus)
Limit values: 0.3 ohm (including mains cable – recommended

Permanently installed: 0.3 ohm (without cable)
Without mains cable: 0.2 ohm +0.1 ohm for cable
Insulation resistance (if required)
L/N->SL
GW SK I >2 Mohm
GW SK II >7 Mohm
Application part: (F) -> SL >70 Mohm
Test voltage: 500 V
Equivalent device leakage current
(L+N to accessible conductive parts + housing, protective conductor is not connected)
Equivalent device leakage current
(L+N to accessible conductive parts + housing, protective conductor is connected)
Attention: Measurement of device leakage current or equivalent device leakage current may be omitted for permanently installed devices which have been connected in accordance with DIN VDE 0107.
Equivalent patient leakage current
All application parts are connected to each other.
Equivalent patient leakage current
Each application part must be measured individually.
Leakage current in accordance with figure 9 – the sum resulting >from housing leakage current (including all accessible conductive parts and all patient leakage currents with the mains plug inserted in both directions, with interruption of the PE connection) Device leakage current (earth leakage current in EN 60601) direct or as differential current – with the mains plug inserted in both directions –  (attention: protective conductor interrupted).
The highest value and line voltage must be documented.
Attention: Measurement of device leakage current or equivalent device leakage current may be omitted for permanently installed devices which have been connected in accordance with DIN VDE 0107.
Patient leakage current
from each application part