Screen Supports for Use in an Operating Room and IEC 60601

[tazer]

Hi All,
A colleague asked me a question that I could not answer.
He works in a service that manufactures "Screen Supports" for use in the operating room. These are only tubes and do not have any cables, it is up to the user to install them there..
He asked me what standards are applicable. He was thinking about the 60601, I do not agree.
I think more to something like contamination, sterilization, ...
Did you have any ideas?

Many thanks.

 

[Pads38]

Re: Screen supports and 60601

I would suggest that a screen (monitor / video) support is not a 'medical device'. However, if it is designed in particular for screens that are 'medical monitors' they could become 'accessories for a medical device' in which case the requirements of 60601-1 could be considered.

Clause 9.8 is entitled 'Mechanical Hazards associated with support systems'. Looking at that, and the rationale in Annex A, shows that a 'support system' can be of any form and may support Patients or Operators or an external load.

So that clause gives requirements for tensile safety factors etc.
Assuming this support is going to be bolted to a wall then sterilisation is not going to be relevant. You would need an assurance of being adequately clean at time of installation. How stringent this should be could be part of your Risk Management process, or may be set by the purchasing authority.

Any cleaning / disinfection during the service life should be identified and form part of the installation and users manuals.

 

[Mark Meer]

Re: Screen supports and 60601

What Pads38 says...

...but this raises an interesting marketing question.
Assuming they are NOT considered medical device accessories, could the OP still market their stand as suitable for (general) surgical room monitors without meeting any particular medical standard?

 

[tazer]

Thank you PADS38
I find your reflection very pertinent.
I understand that, as such, they may not be considered as medical devices. But once linked to a medical screen, they become its accessories and therefore clause 9.8 applies to them, but not only because they will intervene other chapters as 7 and 9.
In this case someone must have them certified, either alone by the manufacturer or bound, by the assembler.
In some catalogs, they are also sold with marketing certifications as "Medical Grade"