EMC Statement in Instruction Manual

N

nikolaos

#11
Cyberice, the declaration of the manufacturing and the tables in the IFU is part of the certification according to IEC/EN 60601-1-2. This is very well explianed in the standard and all Notified Bodies will accept this.
 
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C

cyberice

#12
That's right - but we don't put the tables in the IFU - we only put the link in the IFU - that's I want to explain :) It take a while for us to persuade the auditor - that a link only is acceptable!
Because in our mind it doesn't make really sense to put a table with numbers and units in an IFU for the customer - he won't understand it! :)
 
N

nikolaos

#13
The standard clearly states that the tables must be inserted in the IFU. If the medical device is for hospital use the Medical Engineers should check the tables in the IFU and verify the correct enviroment for proper operation of the device. Table 203 specifies the separation distances between portable a mobile RF equipment and the device. This is an important information for the safe operation of the equipment. A web link can go down anytime and, in my opinion, cannot be used for safety issues
 

Peter Selvey

Staff member
Super Moderator
#14
Just to clarify one possible important point here:

The EMC tables are not required in the instructions for use, although they commonly included there for convenience.

IEC 60601-1 [2nd ed] requirements are split in two parts:

6.8.2 - instructions for use (i.e. instruction manual)
6.8.3 - technical description (i.e. service manual)

The EMC tables fall under Clause 6.8.3, which means there were intended for a service manual. Of course, if a manufacturer chooses not to provide a service manual then the tables should be in the instruction manual.

It should be noted that both the "instructions for use" and "technical description" fall under "accompanying documents" (defined term) which means they must be physically provided with the equipment to comply with the standard.

Providing EMC tables on the web site might be reasonable (I make no comment on this) but it does not comply with the standard. If you do not comply with a standard there are special provisions under the MDD (EU), FDA, Japanese PAL, CMDR, Australian TGA systems. For example, in Europe, the presumption of conformity no longer exists, and you need to provide the "alternate solution" directly against relevant essential requirements. It is not a matter of whether your Notified Body says it is OK or not. The decision is up to you, but you need special evidence.

Also, take care with legal liability. Let's say an EMC interference problem occurs (equipment position closer than as allowed in the table). If you comply with the standard, it is easier to defend. But if the tables are missing (even if they are on a web-site), it is a non-conformity which becomes more difficult to defend against.

I understand the EU thinking about allowing electronic (website) documentation, but no decision yet.
 
N

nikolaos

#15
Just to clarify.
The "Instruction for use" (6.8.2.201 of 60601-1-2) and the "Technical description" (6.8.3.201 of 60601-1-2) for us as a medical device manufacturer is what we call "user's manual". In this manual there are the EMC Tables, and for us is falls under the "Accompanying documents".
We also have a "service manual" with detailed technical description, schemanics, diagrams but this is only for our field engineers and not for the user.
Anyway the tables are 3 pages, where is the problem to include them in the "Accompaying documents?
 
I

iangregson

#16
Is that sufficient ?
MAny IFU I have looked at have a large list of technical data.
I was told you have to demonstrate that your statment meets requirements. I have a similar problem and am struggling to get a definitive answer.
What is the minimum that can be put in IFU ?
 
N

nikolaos

#17
I have the tables as a doc document and can be edited according the instruction of the IEC60601-1-2 standard and the use of the EMC test report from the EMC testing Lab.
After this you can insert them into the user manual, IFU, operator's manual...
I am not sure if I can attach this file to the forum. The file contains just the tables of the standard.
Can a moderator clarify this?
Thank you
 
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