IEC 60601-2-18 (IEC 601-2-18) Particular Requirements for Endoscopic Equipment

william guo

Starting to get Involved
#11
Hello everybody,
I don't open a new thread and have another question about the insulation diagram in Annex J of IEC 60601-2-18:2009. About example 1 of insulation example 101 in figure 201.J.101, why the insulation path 11 is unnecessary? If insulation path 11 is missing, means internal circuit is directly contacted with the outsurface of endocope, and there will be current leakaged between different parts of outsurface of endocope. Even in the 1997 version of IEC 60601-2-18 requires a b-a insulation between the outer surface of endoscope and any live circuit in the endocope.
 
Elsmar Forum Sponsor
#12
Hi William,

you have two options for this insulation diagram - example 1 or example 2:

If you use for area 9 2 × MOPP (MAINS VOLTAGE) than you don´t need area 11.

If you use for area 9 2 × MOOP (MAINS VOLTAGE) than you additioal need area 11. Otherwise you don`t have 2 x MOPP from mains to AP.

For both examples area 10 is importand.

BR,
Daniel
 

william guo

Starting to get Involved
#13
Hi William,

you have two options for this insulation diagram - example 1 or example 2:

If you use for area 9 2 × MOPP (MAINS VOLTAGE) than you don´t need area 11.

If you use for area 9 2 × MOOP (MAINS VOLTAGE) than you additioal need area 11. Otherwise you don`t have 2 x MOPP from mains to AP.

For both examples area 10 is importand.

BR,
Daniel
Hi Daniel,
thanks for your reply.
One point I didn't get. For option 1, the standard considerred the patient direct contacting part and internal secondary circuit as a whole applied part. Because the internal energized circuit is not intended to produce physiology effects, is it acceptable that patient contacts the internal circuit? It really contains a voltage such as 12V. This situation seems descriped as b-a insulation in 1997 version of IEC 60601-2-18.
BR
William
 
#14
Hi William,

I try to explain my point of view.

The 2nd Edition of the IEC 60601-2-18 require the insulation b-a. ( Inner electrical circuit of the endoscope to outer surface). Annex AA mention, that the endoscope have to be tested without connection to the supply unit. That was discussed some years ago in this thread.

The 3rd Edition require 2 MOPP from mains and 2 MOPP from inner electrical circuit as well. Additional require the IEC 60601-2-18 for endoscopic equipment BF or CF. That means, that the endoscope have to be completely separated from PE.

If your endoscope ( which is not intended to produce physiology effects to the patient) is powered with energy which is completely separated from PE ( floating circuit) its, from my point of view, okay. Of course, all MOPP´s have to be provided in the supply unit. In the endoscope you have only functional isolation.

If you perform Dielectric strength test from mains to AP -> no breakdown, because of insulation area 9 in the supply unit.
If you perform Dielectric strength test on area 10 ( outer surface Endoscope to PE) -> no breakdown, because of floating circuit. IEC 60601-2-18 3rd don’t consider to test the endoscope disconnected to the supply unit.

Best regards,
Daniel
 
Thread starter Similar threads Forum Replies Date
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
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
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
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
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Transformer Requirements - IEC 60601-1 vs. IEC 61558-2-15 IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T Clearance and Creepage according to Subclause 8.9.1 for MOPP IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A IEC 60601-1 and IEC 60601-2-2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3

Similar threads

Top Bottom