Leakage Current Measuring Instrument - IEC 60601-1 Requirement

M

MSouza

#1
I'm building a setup to measure leakage current described in IEC 60601. My problem is to find a multimeter to use to measure the voltage across the humam body model with these specs:

"The measuring instrument referred to as MD shall have an input impedance (Z) of 1MW and a frequency characteristic that is flat from DC to 1MHz."

It's possible to find a multimeter with these specs?

Tanks
MSouza
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 

Peter Selvey

Staff member
Super Moderator
#3
Most test labs will use a multimeter for general purpose, and an oscilloscope if higher frequencies are suspected.

Multimeters vary greatly in frequency response so you need to check the specification. Typical ranges are from 20kHz for cheap to 100kHz for high end meters.

Many labs have a special wide band rms meter which is specified up to 1MHz or higher. But I found a close look at the specs on these meters is pretty bad. They were really designed for work in the dB region, where a 5 or 10% error is nothing much.

In truth, measurements above about 50kHz take some work to get accurate, not just the meter. The problems increase with frequency. Towards the 1MHz end, most ad-hoc laboratory set ups would probably have errors exceeding 50%.

But, it is not a real issue as it is rare to have a source of high frequency with significant current, enough to get close to the limits.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#5
Thanks for getting back to us and letting us know what you did.
 

Peter Selvey

Staff member
Super Moderator
#6
The AD636 has a headline 1MHz bandwidth, but if you look closely the specs you find the 1% bandwidth is only 14-130kHz depending on signal size. I got caught out once with the AD637, with a similar problem that the headline spec is misleading.

The AD734 has a headline spec is 10MHz, which means at 1MHz it remains accurate, but it needs >100mV input, and has only 50k input impedance. So you will need a buffer amp with gain, I suggest LM7171.

And of course you will still need to take care with the design around front end at higher frequency.

Also note that for the "mains on applied part" and similar tests the voltmeter is at mains potential, so it needs to be isolated and should have CMRR >90dB. But as there are no higher frequency components in that test, using a standard battery operated multimeter should be OK.
 
Thread starter Similar threads Forum Replies Date
S Calibration - Isolated current meter - Measuring patient auxiliary leakage current Calibration and Metrology Software and Hardware 4
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Earth leakage current test for Permanently installed Large scale MEE IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
T Tests IEC 60601-1 - Grounding Resistance, Leakage Current and Dielectric Rigidity in an automated way IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Leakage Current test and Dielectric strength for Battery operated ECG device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
M Leakage current measurement with non-frequency-weighted device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E IEC 60335-1 leakage current measurement Other ISO and International Standards and European Regulations 3
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
W How can I test the Patient Leakage Current of an Infusion Pump? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
A Accuracy Calculation of Leakage Current for an Electrical Safety Analyzer General Measurement Device and Calibration Topics 5
J Exceeding the DC Leakage Current Limit IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
L Building your own Leakage Current Tester IEC60990 Other US Medical Device Regulations 4
R IEC 60601-2-49 - Touch Current (Enclosure Leakage Current) requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Medical Device Leakage Current Measurement with External Power Supply IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R Why DC limits more stringent than AC limits for Leakage Current Test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Pre-Conditioning Leakage Current IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
M Operator/Patient Leakage Current IEC 60601 - Battery Charger IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
P Leakage Currents and Patient Auxiliary Current under IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Leakage current from battery - IEC 60601-1 Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
N 60601-2-2 Ed 6 Clause 201.8.8.3.102 - HF instrument leakage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Measuring Leakage Currents with IEC 60601 defined Measurement Device (MD) IEC 60601 - Medical Electrical Equipment Safety Standards Series 15
M ISO 13485 - Are Earth Leakage Tests Required? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Patient Leakage ISO 7176-14 vs. IEC 60601-1:2005 Reporting Requirements Other US Medical Device Regulations 1
M IEC60601-1 Battery Powered Body Worn Device Leakage Currents IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Understanding DC Patient Leakage Failure from 0.3VDC IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Whether some paths exist for leakage to get outside the LCD? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
C USB, Clearances and Earth Leakage - Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
K Calibration method for Torque Wrench & AC gas leakage Tester General Measurement Device and Calibration Topics 4
W FMEA - Current control and occurrence rating FMEA and Control Plans 3
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 4
W Need for current design or process control FMEA and Control Plans 2
E Best way to keep up with pharmaceutical quality knowledge and current affairs Service Industry Specific Topics 1
T Iec 60601 Impedance and current-carrying capability IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
F Proficiency Testing for ISO 17025: AC Current Ranges ISO 17025 related Discussions 1
Q Raising A CAPA on Current CAPA system US Food and Drug Administration (FDA) 3
A SPC for Eddy Current Testing Statistical Analysis Tools, Techniques and SPC 28
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
A QMS - Medical Device - New company under a current one ISO 13485:2016 - Medical Device Quality Management Systems 3
K Questions on Technical File to show it is current EU Medical Device Regulations 5
H IS there any database for list of CE marked Medical devices and there current status EU Medical Device Regulations 8
B Mains fuses and OVER-CURRENT RELEASES IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Adding an additional distributor to a current Mexico Medical Device Registration Other Medical Device Regulations World-Wide 0
M IEC 60601-1 and Active Current Protection Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Testing a Low Current (Battery) DC Medical Device Other Medical Device Related Standards 4
D Referencing Standards in Procedures - Current version or actual? Document Control Systems, Procedures, Forms and Templates 6
I Curious if a List of Current Standards Revisions Exsists Other Medical Device Related Standards 3

Similar threads

Top Bottom