Insulation Diagram IEC60601

[Ohad Barsheshet]

Hey!
New to the business of IEC60601 so please bear with me
I was advised before planning any further into my electrical design and manufacturing to form an insulation diagram to plan my device in a safer way and smart way so i wont need to do back tracking and reengineering that will be costly.
After looking for information and ways to make such diagram I got overwhelmed and kind of confused, i would like to get any information and tips on the subject.
maybe information on what should it include?
what needs to be specified?
table of context? what does it need to include?
what should be marked and checked in terms of MOPP
keep in mind every insulation diagram i saw has a MOOP since it has an applied part while my device don't.

Thanks in advance to anyone willing to help a fella out

 

[FelipeSchneider]

Hi Ohad, indeed, the amount of information available about the 60601 and the Insulation Diagram is overwhelming, therefore, it is basically impossible to describe all points regarding the design of an Insulation Diagram in a single post.

There are really nice discussions about this theme in this forum, I even started one topic about it last week. Please check this post:
Grounded (PE) Cable foil as Means of Patient Protection and solid insulation levels for secondary circuits

There you will find an Insulation Diagram example of a device without applied part.
You should also keep in mind that you may need to treat some accessible parts as applied parts. Additionally, you need to provide at least 2 MOPP for everything that is inside the Patient Environment (or have a good reasoning for not doing that).

 

[Ohad Barsheshet]

Hi Felipe, Thank you for the advice I will go through your post soon.
My problem with the Insulation Diagram is that I couldn't find any source of information explaining exactly what are MOPP'S (since they are the only one I need) if you have any solid explanation on what counts as MOPP or where do I need to give reasoning to them I would appreciate it a lot.
I've taken into consideration accessible parts that can be counted as Applied Parts like the standard demands and after through thinking and considering my device doesn't have one.

To sum up my main problems are:
1. Not knowing where to input the MOPP'S in the diagram(Where are they needed)
2. What is that said patient Environment and what does it include, How does it effect my devices planning
3. There are some details needed to be filled like (Pollution degree, Over voltage category, Altitude, Material group) which I don't know where to get the details for
4. In terms of Dielectric strength what is exactly tested?


General Questions:
Creepage distance and Air clearance are counted as MOPP in the cable cord power input?
Do you have any table of context to explain your insulation diagram? ( I feel like if I knew why you chose those places to act as MOPPS I'd understand them in context to my medical device)

I Appreciate your kindness to help me out and look forward to your response

Best,
Ohad

 

[FelipeSchneider]

Ohad, it seems that you haven't read the 60601 yet. Trust me, it is worth! It seems to have 1000 pages and you will never finish it but the part that you need is much smaller than you think...

Put that in place, some comments about your questions:

My problem with the Insulation Diagram is that I couldn't find any source of information explaining exactly what are MOPP'S (since they are the only one I need) if you have any solid explanation on what counts as MOPP or where do I need to give reasoning to them I would appreciate it a lot.

• You also gonna need some MOOPs. A clear example is that, if you have a power cable connected to the mains, this power cable must be certified for medical use.
• You can use multiple methods as MOOPs and MOPPs:
  • Solid insulation (like a non-conductive material)
    • You also may count transformers
  • Air gaps and creepages
  • Grounding
• Each of those methods has some requirements and they are described throughout the first chapters of the 60601 (especially on the 8th).

1. Not knowing where to input the MOPP'S in the diagram(Where are they needed)

The basic principle here is that you can't expose the patient or the operator to a not acceptable risk if one Means of Protection fails. But the story is not limited to this simple explanation.

2. What is that said patient Environment and what does it include, How does it effect my devices planning

The standard brings a full and clear definition to this question. A simple CTRL+F will help you. Also, check Figure A.9.

3. There are some details needed to be filled like (Pollution degree, Over voltage category, Altitude, Material group) which I don't know where to get the details for

You and the Risk Analysis Committee need to evaluate the environment where your device will operate. If you are not sure about the pollution degree, play safe.

 

[akp060]

Additionally, you need to provide at least 2 MOPP for everything that is inside the Patient Environment (or have a good reasoning for not doing that).

Just a note..
"A patient can also be an operator" (Sub-clause 3.76, Ed 3.2). Hope this helps

 

[Ohad Barsheshet]

Thanks guys I appreciate the helpful notes and good spirit!!
I did read some of the standard but not as much.
I will continue to read it and figure stuff out

Best,
Ohad