SBS - The best value in QMS software

IEC 60601-1 Electrical Safety testing - Class 1 ME externally powered - Earth resistance testing

J

Jason Raddatz

#1
I'm running into an issue with electrical safety testing on a class 1 ME externally powered device. The device can operate both via a removable battery pack, or an external power adapter. The device is labeled as Class 1, however there are no exposed protective earth conductors on the chassis. All metal components are only functional earths, with resistance above 0.2 Ohms. The protective earth, is located inside the external power adapter, which of course is not accessible during safety testing. Is earth resistance testing required for this device? If so, how can earth resistance be measured if there are no accessible protective earth points in the chassis?
 
Elsmar Forum Sponsor
#2
1. Disconnection of functional earths is considered a Normal condition. Your equipment shall respect earth leakage current limits with the FE disconnected. Also EMC tests shall be carried with FE disconnected.
2. Plastic enclosure shall guarantee 2 MOP since earth protection is not guaranteed. Therefore, Dielectric withstand levels and separation distances are doubled.

If your device remains compliant under theses conditions, then I think that it respects the requirement of the standard.

Regards
 

Peter Selvey

Staff member
Moderator
#3
For periodic electrical safety testing, it is clear that no test is required for this situation.

In a type test, the earth resistance should be tested to all parts where the earth is close to mains parts. This cannot be done from the outside of the equipment, unless the manufacturer has neatly daisy chained all the parts in series without parallel paths, and designated a special test point such that the 25A current passes through all the critical points. And pigs might fly. In other words the test that is normally done in periodic electrical safety testing is not anyway really testing all the internal earth connections are OK.

However, you might face some trouble if you leave it blank. So I would suggest writing something like "no externally accessible earthed parts, would require disassembly to test, which is not warranted". That means that anyone that wants to challenge it needs to address the risks associated from pulling the equipment apart, which are clearly far higher than any benefit received from the test.
 
Thread starter Similar threads Forum Replies Date
R IEC 60601-1 - Magnesium oxide used for the electrical insulation of heating elements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen 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
G Electrical Safety standard for medical device not covered by IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
JoCam Medical Device that is class II electrical and IEC 60601-1-11 EU Medical Device Regulations 5
P IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
P Recommended Books on Electrical Safety Compliance for IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
N RS485 stand to meet the EFT (Electrical Fast Transients) test according to IEC 60601 ISO 13485:2016 - Medical Device Quality Management Systems 3
B IEC 60601-1 2nd Clause 17 and 3rd edition - Electrical Isolation IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M IEC 60601 Medical electrical equipment - Send declaration and guidance to customers? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
F Medical Electrical Equipment / System Peripherals - IEC 60601-1-3 IEC 60601 - Medical Electrical Equipment Safety Standards Series 16
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
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
A IEC 60601-1 Dielectric Strength test for battery operated devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
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
K Dielectric strength test as per IEC 60601-1 -Infant incubator IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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

Similar threads

Top Bottom