Does EN 60601-1 apply to stand alone software medical devices?

andreiafilipaf

Inactive Registered Visitor
#1
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!
 

sagai

Quite Involved in Discussions
#2
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!
 

raymond02302

Quite Involved in Discussions
#3
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).
 

sagai

Quite Involved in Discussions
#4
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
 

c.mitch

Quite Involved in Discussions
#5
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.
 

Peter Selvey

Trusted Information Resource
Trusted
#6
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.
 

yodon

Forum Moderator
Staff member
Moderator
#8
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 :eek: ).

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)?
 

Pads38

Quite Involved in Discussions
#9
Hi Don,

What MDD class is your software? Class I, IIa, IIb or III?

and what is your 62304 classification A, B or C?

MDD Class I has no notified body involvement. The 62304 and 62366 work is still required, but the extent of such efforts can be tailored to the risk profile of your device/software.

For higher classes, where NB involvement is required, as the 2 standards are more 'process' standards, rather than a 'test' standard the NB may accept your own documentation.

The NB we use now says that they do not have the technical expertise to accept / decline our internally produced test results. They have to be reviewed by an accredited test house (another arm of the same organisation).

This adds time and cost - but is much less than a full external test proramme.
 

Peter Selvey

Trusted Information Resource
Trusted
#10
There is no requirement in the MDD for 3rd party assessment for any standard.

Some general standards like IEC 60601-1 and IEC 60601-1-2 require experience and test equipment that the average manufacturer does not have, so it makes sense (more efficient) to contract an external lab.

But many regulatory standards can be handled in-house. Typical examples include particular standards where the manufacturer can have better equipment/experience than an external lab, and management system standards like IEC 62304 and IEC 62366 where there is little benefit in engaging external labs (there's no measurements, objective criteria, etc. so the labs just charge money and don't take any responsibility, no real added value).
 
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