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Does EN 60601-1 apply to stand alone software medical devices?
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Does EN 60601-1 apply to stand alone software medical devices?
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  Post Number #1  
Old 2nd November 2012, 01:37 PM
andreiafilipaf

 
 
Total Posts: 17
Question Does EN 60601-1 apply to stand alone software medical devices?

Hi

I would like to know if EN 60601-1 applies to software stand alone medical devices?

Also, can a collateral standard like 60601-1-6 be applicable when the main one (60601-1) is considered not applicable?

Thank you!

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  Post Number #2  
Old 2nd November 2012, 03:49 PM
sagai

 
 
Total Posts: 1,133
Re: Does EN 60601-1 apply to stand alone software medical devices?

I have heard about it ones, but having a chat with the auditor he had dropped this idea.
EN ISO 14971:2012 is the one that you may looking for EU legislation (or non of these, up to you )
Cheers!
  Post Number #3  
Old 2nd November 2012, 10:32 PM
raymond02302

 
 
Total Posts: 61
Re: Does EN 60601-1 apply to stand alone software medical devices?

EN 60601-1 is applicable to software embedded in medical equpment. IEC 62304 is applicable to stand alone software medical equipment.

IEC 60601-1-6 is cllateral standard usd in conjunction with IEC 60601-1. you can use IEC 62366 for assessing usability engineering. For USA, you can use AAMI HE 74 (process) and AAMI HE 75 (principle).
  Post Number #4  
Old 3rd November 2012, 03:53 AM
sagai

 
 
Total Posts: 1,133
Re: Does EN 60601-1 apply to stand alone software medical devices?

I am not sure if "applicable" means almost the same for all readers, so let me put it this way.

The mentioned IEC 62304, IEC 62366 and ISO14971 are voluntary standards both for EU and US legislation.

Cheers
  Post Number #5  
Old 11th November 2012, 08:18 PM
c.mitch's Avatar
c.mitch

 
 
Total Posts: 175
Re: Does EN 60601-1 apply to stand alone software medical devices?

If you want to get clearance in the US, I would add to Sagai's list the General Principles of Software Validation, guidance of the FDA.
As far as I know, neither IEC 60601-1 nor its collaterals apply to standalone software.

I would add a restriction: unless that software in an accessory of a electromedical device. But this was probably the case you were thinking of in your initial post.
  Post Number #6  
Old 12th November 2012, 10:23 AM
Peter Selvey

 
 
Total Posts: 899
Re: Does EN 60601-1 apply to stand alone software medical devices?

The phrase "stand alone software" usually means software sold on it's own with the intention to be installed by the user, usually on a PC, usually for data analysis (diagnosis) or other intermediate processing.

Under regulations stand alone software usually considered a "medical device" although there is no actual physical "device" as such, so it can get confusing.

IEC/EN 60601-1 is not applicable, since there is no physical device. Since EN 60601-1 does not apply, none of the collateral or particular standards apply.

IEC/EN 62304 is applicable - it applies to all software, whether embedded, stand alone or otherwise. EN 62366 (usability) is also applicable to all medical devices, including stand alone software.

"Applicable" here means according to the scope of the standard, noting that most modern regulations allow the use of alternate methods to standards, if properly documented.
Thanks to Peter Selvey for your informative Post and/or Attachment!
  Post Number #7  
Old 12th November 2012, 10:25 AM
andreiafilipaf

 
 
Total Posts: 17
Re: Does EN 60601-1 apply to stand alone software medical devices?

Thank you All for your feedback!
  Post Number #8  
Old 1st December 2016, 12:38 PM
yodon

 
 
Total Posts: 1,158
Re: Does EN 60601-1 apply to stand alone software medical devices?

Quote:
In Reply to Parent Post by Peter Selvey View Post

The phrase "stand alone software" usually means software sold on it's own with the intention to be installed by the user, usually on a PC, usually for data analysis (diagnosis) or other intermediate processing.

Under regulations stand alone software usually considered a "medical device" although there is no actual physical "device" as such, so it can get confusing.

IEC/EN 60601-1 is not applicable, since there is no physical device. Since EN 60601-1 does not apply, none of the collateral or particular standards apply.

IEC/EN 62304 is applicable - it applies to all software, whether embedded, stand alone or otherwise. EN 62366 (usability) is also applicable to all medical devices, including stand alone software.

"Applicable" here means according to the scope of the standard, noting that most modern regulations allow the use of alternate methods to standards, if properly documented.
Apologies if this has been answered elsewhere. This was the first one I found in a search (and didn't take the time to go through the other 50 pages ).

I am wondering if anyone has had experience pushing stand alone software through CE marking. I agree that 62304 and 62366 are applicable but who makes the assessment? Is it typically the NB or should an independent test lab do it (like they do when it's software contained in a device)?
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