Do they use the same standards: Stand-alone software and embedded software?

C

CoWorkerM

#1
Hello,

any comments are appreciated to the following question, which I will demonstrate using an example:

Suppose you as manufacturer are building a medical device which is a medical system consisting of
- a medical equipment: an ECG sensor consisting of patient cable, electronic including CPU, embedded software, housing, USB connector to the PC
- non-medical equipment: PC including peripheries as printer etc
- a medical device: PC software working on the PC for recording, saving, printing, exporting, evaluating, and archiving the ECG recordings

Which software standards have to be applied?

1) IEC 62304 for the PC software and IEC 60601-1, chapter 14 PEMS for the embedded software in the ECG sensor?

2) IEC 62304 also for the embedded software in the ECG sensor?

3) IEC 60601-1, chapter 14 PEMS also for the (stand-alone) PC software?

Remarks: IEC 62304 states in "1.2 Field of application": This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.
IEC 60601-1, 3rd ed.: PEMS consists of PESS and PESS contains per definition one or more CPU.

Looking at those definitions, it is most straight forward to say "yes" to all three questions.
 
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c.mitch

Quite Involved in Discussions
#3
Hello,
To begin with, I exclude the non medical equipmt of this discussion.

1) IEC 62304 for the PC software and IEC 60601-1, chapter 14 PEMS for the embedded software in the ECG sensor?
Yes, this was my first thought when I read your post. I usually think 60601-1 equals embedded and 62304 equals software.

2) IEC 62304 also for the embedded software in the ECG sensor?
This is my second thought. Well, if there is software in the ECG sensor, then 62304 should be applicable (see field of application of the standard).
But section 14 of 60601-1 already defines requirements about software.
So, what to do?
It depends on the size of the embedded software. If it is a very small software made (say, one or a few source files) then 60601-1 section 14 is enough. If the software is big enough to do what's required by 62304: architectural design and detailed design, then 62304 is applicable.
Coming back to your case. Since your embedded sw communicates with the
PC, I would say that it is relevant to consider both as two parts of a system and apply 62304 to the whole.

3) IEC 60601-1, chapter 14 PEMS also for the (stand-alone) PC software?
No, standalone software is immaterial has no applied parts and is not subject to hardware mechanical/chemical/physical hazards. Thus it is not covered by 60601-1.

Regards.

Mitch.
 
#4
I would highlight the fact that clause 14 of 60601 states that it only applies to software that provides 'Essential Performance' or 'Basic Safety'.

And Annex C of 62304 shows how it is related to other standards, including 60601. It points out that Software Validation is not covered by 62304, as it is a 'system' level requirement. See figure C2 for a diagram of the portions of the "V model" of software development that lie outside the scope of 62304.

So, in answer to the original question of which standard to use - both of them.
 
C

CoWorkerM

#5
To answer to Pads38:

> I would highlight the fact that clause 14 of 60601 states that it only applies to software that provides 'Essential Performance' or 'Basic Safety'.

Embedded software in an ECG sensor is not a small program, actually it has to cover the A/D process, the pacemaker detection in the signal, the configuration of sample rate and amplification, the buffering, the protocol handling and some other minor tasks. It also - in most cases depending on the intended use - provides 'Essential Performance', because ECG signal malfunction (modification or artefacts) could be a hazardous situation which potentially leads to wrong diagnosis.

> So, in answer to the original question of which standard to use - both of them.

So you mean: both of them for both software: embedded and stand-alone?

To answer c.mitch:

> 3) IEC 60601-1, chapter 14 PEMS also for the (stand-alone) PC software?
> No, standalone software is immaterial has no applied parts and is not subject to hardware mechanical/chemical/physical hazards. Thus it is not covered by 60601-1.

This is a great argumentation, I am thinking about it...
 
C

CoWorkerM

#6
Hello,

I would like to add some information to 3) also to follow up the discussion with c.mitch:

60601-1 states in 1.1 (Scope of application) that this norm applies for the 'Essential Performance' or 'Basic Safety' of medical electrical equipment (ME equipment) and medical electrical systems (ME systems).

A ME equipment is a device that connects to the patient (to shorten it a bit).
A ME system is a combination of devices that at least holds one ME equipment.

Now, the ECG sensor is a ME equipment, and therefore 60601-1 applies.

The PC with the PC software can be - looking at the example described in image A.7 (appendix 3.8)

- either together with the ECG sensor and the electrodes ONE ME equipment if the manufacture wants this to be so. This may result in other difficulties (eg. the verification of 60601-1-2 together with the PC). In this constellation the PC and the PC software is within the ME equipment and therefore 60601-1 and chapter 14 PEMS applies for the PC software also.

- or it can be part of a ME system where the system consists of the ME equipment (the ECG sensor) and another device, the PC (office device) with the PC software (which is a medical device). In this case, the PC software is a part of a ME system, and this hole system is a PEMS.
(see definition of a PEMS: ME equipment or ME system holding one or more PESS). Now, the PC software is a PESS of PEMS of a ME system and therefore 60601-1 applies also for the PC software.

Being logical, 60601-1 always applies to PC medical software, as long as the PC with the software is the part of a ME system as in our case.

Another argument is, such systems of PC-based ECG diagnosis are older than the 62304. And before, the 60601-1-4 (PEMS in 2nd edition) has been applied. Why should this stop now, just because 62304 has been published?

So, is there anybody out of the FDA, the NB or the writers of the norms or what's with the other applicants who know what to do and why?
 
C

CoWorkerM

#7
Hello,

adding to the question 2):

In a document shortly published by the team NB:
[www].team-nb.org/documents/2013/FAQ_62304_Final_130804.pdf (sorry, not having yet posted 10 posts, I was not able to include links. Pls. reconstruct)

we find in section 2.1 "Scope of EN 62304":

Assuming all software has a medical purpose, does the standard apply to the following?
b) Embedded software including FPGA's with single chip computers

Answer: "Software executed on a processor (can also be part of a FPGA) during the intended operation is considered a software item under EN 62304."

Embedded software is included in the scope of 62304?!
 

sagai

Quite Involved in Discussions
#10
It is more or less only up to your regulatory plan for your particular product and/or also up to the compliance explicitly may be declared in you quality management system.
Other than that ... nope ...

One question relates to this subject. Are you looking into IEC/TR 80002-1:2009 as well?

Regards
 
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