SBS - The best value in QMS software

IEC 60601-1 Dielectric Strength test for battery operated devices

#1
Hi,

I have seen multiple posts regarding the confusion behind the test voltages for the dielectric strength testing and would appreciate any clarification on the following question.

For a rechargeable battery operated medical device that is charged using a mains supply, would the dielectric strength testing as per the IEC 60601-1 Clause 8.8.3 be required. The medical device is a single Type BF applied part with multiple functions. Since it is mainly operating in the battery mode (U <60Vdc), would the test voltage be 500Vrms (1MOPP)? However, the testing lab is considering the mains supply as the working voltage and test at 1500Vrms.

How do we work around this?
 
Elsmar Forum Sponsor

Benjamin Weber

Trusted Information Resource
#2
As long as it is possible to apply the device on the patient while it is connected to mains, the mains voltage is the correspponding working voltage.

The question is: Is there solid insulation used as a means of protection against electric shock? Only if so, dielectric strength has to be tested on the corresponding part. Also be aware that you need 2 MOPP vs. mains voltage (test voltage ususally 4kV, but depends on the actual mains voltage!), not only 1 MOPP (usually 1.5kV, but depends on acutal mains voltage). But maybe the missing 1 MOPP is implemented by dreepage/clearances?
 

Peter Selvey

Staff member
Moderator
#3
This might a different issue. If the device is Type BF, the "F" in the BF (or CF) indicates that the applied part is floating and can withstand the applied part (patient) being raised to mains voltage while limiting leakage currents back into the device.

For this, the related insulation is required to be 1MOPP at mains supply (typically 1.5kV, 4/2.5mm cr/cl).

This is a special rating for the applied part and has nothing to do with the power supply. Even fully battery operated devices need to comply with this test, and they are assigned a special reference voltage of 250Vac just for this test.

Think of it like a IP rating, whether or not you think it is important, once you mark the device as say IP67 it has to pass the IP67 test.

Same with BF: once you put the BF symbol on, it has to comply with the 1 MOOP @ 250V
 
#4
This might a different issue. If the device is Type BF, the "F" in the BF (or CF) indicates that the applied part is floating and can withstand the applied part (patient) being raised to mains voltage while limiting leakage currents back into the device.

For this, the related insulation is required to be 1MOPP at mains supply (typically 1.5kV, 4/2.5mm cr/cl).

This is a special rating for the applied part and has nothing to do with the power supply. Even fully battery operated devices need to comply with this test, and they are assigned a special reference voltage of 250Vac just for this test.

Think of it like a IP rating, whether or not you think it is important, once you mark the device as say IP67 it has to pass the IP67 test.

Same with BF: once you put the BF symbol on, it has to comply with the 1 MOOP @ 250V
Would it be possible not to use the BF classification, even if your device is internally powered and has no way to be connected to a main supply? Could we classify the device as a type B just to avoid having to go through dielectric strength testing?
 
Thread starter Similar threads Forum Replies Date
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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 IEC 60601-1 Electrical safety testing - Dielectric Strength Test - 8.8.3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Dielectric Strength of Electroshock - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C INMETRO 350 Dielectric Strength Test to IEC 60601-1 clauses 18, 19 and 20 Other Medical Device Regulations World-Wide 5
S Issues with Dielectric Strength Testing - IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
R Current Limit in IEC 60601 Dielectric Strength Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D IEC 60601-2-37 - No Dielectric testing specifications? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Outsourcing IEC 60601-1 Ed 3.2 Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Complex IEC 60601-1 gap assessment IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
H IEC 60601-1 ME equipment or ME system IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R IEC 60601-1 - 11.1.3 e) Test criteria - Temperature Measurements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Z IEC 60601-2-25; Frequency response test Medical Device and FDA Regulations and Standards News 1
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B IEC 60601 - Creepage Distance - Relay that acts as a means of physical mechanical protection Process Maps, Process Mapping and Turtle Diagrams 0
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M What to Expect from Next IEC 60601-1 and IEC 60601-1-2 Amendments? IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
R Hand transmitted vibration 9.6.3 of IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W IEC 60601 - Essential performance c.2.34 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-43 - Clause 203.6.103 - Physical button? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E IEC 60601-1 - Unearthed Medical Device Metal Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
JoCam Failure to test Class I medical device to IEC 60601-1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 - Different methods of achievement of the isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
A Unused SIP/SOPs - IEC 60601-1 and IEC 60601-1-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
K Sequence of testing in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B IEC 60601-2-10 - Accuracy of Pulse Parameters - Required Measurement Uncertainty IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
DitchDigger IEC 60601-1 subclause 5.1 - Adequate evaluation in lieu of testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom