IEC 60601-1 and ISO 14971 Assessment

hornet456

Starting to get Involved
#11
The form I mentioned earlier is now at version 2.3 and can be found here:-

It lists every sub-clause of 60601 (and collaterals) that require the RMF and shows which elements of 14971 need to be addressed.
Appreciate the link! - I see that the latest version of ISO 14971 in that link is only 2007. Any advise on how to map the 14971:2012 version?
 
Elsmar Forum Sponsor
#12
Any advise on how to map the 14971:2012 version?
The only difference between 2007 and 2012 versions is the addition of the Z annexes. Without being overaly cynical they do not add anything and can be ignored.
When a reviewer states that the reference should be 2012 correct them by stating that it is part of the official IECEE form.
 

silentmonkey

Involved In Discussions
#14
Your experience is valuable to people like me who are new to the regulatory environment. Thank you!
Hi Hornet,

I'm in the same shoes as you were 9 months ago! A test lab in Korea is requesting to see all clauses from 60601-1 included as a risk in our risk management file. We have already included all the clauses from 60601-1 as design inputs and generically covered electrical hazards by complying to 60601-1.

The requested action seems redundant. Would you be able to share any advice about how you managed the situation?

Thank you kindly. I've also sent you a PM.
 

Peter Selvey

Staff member
Super Moderator
#15
Unfortunately this is the standard, not the test lab. Wherever the standard refers to risk management as part of the requirement, the test lab is expected to inspect the risk management file. It's a huge pain not only for the manufacturer but also the test lab. The best thing is to bite the bullet and prepare a few line items or in a separate section in the risk management that cover those clauses. Even if it is in a separate section, make sure to keep the same format as used in the main RM table, i.e. the sequence of events, probability, severity, risk estimation, decision on risk acceptability, risk control (link), verification (link), validation (post risk control numbers) etc.

You can keep it simple. The key point is to understand the "legal" minimum, i.e. the minimum records that ISO 14971 states are required for each line item.

To give an example, Clause 7.2.2 says that detachable parts must be marked with the manufacturer's name and a type/model number unless there is no unacceptable risk. If a manufacturer decides not to mark a detachable part then that manufacturer is required, in a sense legally required, to show probability and severity numbers and other ISO 14971 records to support this decision. It doesn't matter how obvious the decision is, those records are required.

It's important to keep in mind that virtually every medical device on the market has pinch points, areas where they really should be doing more but commercial reality, competition, cost, complexity, conflicts and just plain old "my device is wonderful" bias means that short cuts are taken. More often than not, 601 hits some of these nails on the head in an RM clause. At that point, the probability, severity, risk criteria etc suddenly become more than just redundant :)
 

silentmonkey

Involved In Discussions
#16
Unfortunately this is the standard, not the test lab. Wherever the standard refers to risk management as part of the requirement, the test lab is expected to inspect the risk management file. It's a huge pain not only for the manufacturer but also the test lab. The best thing is to bite the bullet and prepare a few line items or in a separate section in the risk management that cover those clauses. Even if it is in a separate section, make sure to keep the same format as used in the main RM table, i.e. the sequence of events, probability, severity, risk estimation, decision on risk acceptability, risk control (link), verification (link), validation (post risk control numbers) etc.

You can keep it simple. The key point is to understand the "legal" minimum, i.e. the minimum records that ISO 14971 states are required for each line item.

To give an example, Clause 7.2.2 says that detachable parts must be marked with the manufacturer's name and a type/model number unless there is no unacceptable risk. If a manufacturer decides not to mark a detachable part then that manufacturer is required, in a sense legally required, to show probability and severity numbers and other ISO 14971 records to support this decision. It doesn't matter how obvious the decision is, those records are required.

It's important to keep in mind that virtually every medical device on the market has pinch points, areas where they really should be doing more but commercial reality, competition, cost, complexity, conflicts and just plain old "my device is wonderful" bias means that short cuts are taken. More often than not, 601 hits some of these nails on the head in an RM clause. At that point, the probability, severity, risk criteria etc suddenly become more than just redundant :)
Hi Peter,

Thanks for the advice. Your earlier post back in 2018 sums up really well some of my current thoughts. We have risk items in the file which are pending the lab test report and can't sign them off creating that circular reference.

In our Hazards Analysis, we have a generic line item regarding electrical faults under normal and single fault conditions and the risk control is we have designed in accordance with 60601-1, hence the risk has been controlled taking into consideration the current state of the art. Additionally, we have extracted each clause from the electrical standards and added them as design requirements into our design traceability matrix.

Therefore, we have confidence that all risks found in 60601-1 have been reduced as low as possible (EU), and makes doing this exercise in our risk management file redundant and non-value adding.

Do you think the above might be an acceptable response to the test lab? If we are just stuck due to the wording of the standard, then what value do we get as an organisation in doing this exercise (other than just because its required)?
 

Peter Selvey

Staff member
Super Moderator
#17
We could be talking about two different things here. My personal opinion is that items handled completely within the standard (i.e. the standard provides an objective requirement and assessment) AND uses well established technology does not need to appear at all in the main hazard analysis table.

In electrical safety (fire/shock) there are literally thousands of risk controls, much of which is far beyond the end device manufacturer's ability to even be aware of let alone be competent in assessing the risk. So for that part I entirely agree, no point in even having a line item.

I would just mention somewhere in the RM file that hazardous situations covered by published standards, with objective requirements and compliance criteria and where compliance is achieved through the use of well established technology are not included in the hazard analysis. And then add a list of standards applied or a pointer (e.g. to list of applied standards in the specifications).

However, in the case that an individual clause in a standard has subjective or flexible requirements, and/or makes a specific reference to risk management, or where the technology used for compliance is new or unusual, then I think there should be a corresponding line item in the hazard analysis table. These are the items that I am talking about.

For IEC 60601-1 itself, there are likely to be only 10-20 applicable items for the average medical device which fall into this category. So it's not a huge task, even if some of them are likely to be obviously OK. The above mentioned example of 7.2.2 (not marking a detachable part) is one case. Spillage is another (11.6.3). These are clauses that have deliberately introduced some flexibility, allowing the manufacturer rather than the standard to decide what is OK or not. The trade off is that it has to be written up in risk management.

While it might seem redundant, chances are that when they are listed up systematically there's likely to be one or two items that a design is sailing close to the edge of reasonable, so the RM write up starts to add some value.

There are some clauses in 601-1 where the authors have used risk management to be lazy, by covering big subjects like performance. The "line item" that matches those clauses is likely to be a bit of a fudge, which is worse than redundant. But at least for now, the test lab needs to link to something in order to complete their report, so fudge it has to be.

Regardless, if individual clause has a specific reference to risk management and there is no line item for the test lab to link to, their only choice would be to record verdict of "not evaluated". They cannot record "Pass". Full stop. This is the key point to understand, as much as the test lab might want to they can't just make things up to fit each manufacturer's whims.

That said, I do a lot of direct (non-accredited) reports for manufacturers and "N/E" is a popular option!
 

Tidge

Trusted Information Resource
#18
I agree with the response by @Peter Selvey , but I want to make my own comments on:
We could be talking about two different things here. My personal opinion is that items handled completely within the standard (i.e. the standard provides an objective requirement and assessment) AND uses well established technology does not need to appear at all in the main hazard analysis table.
I used to be in very firm agreement with this assessment, because the previous (2012) revision of 14971 included (in the informative annex D.5.5, D.6.3, as well as the concept of 'practicable' ) guidance on the application of different 'contexts' that for certain risks which are specifically addressed in an applicable standard with prescribed requirements and test methods that there wasn't much benefit in spilling ink (in a risk file) for such risks beyond identification of those design outputs which (in a 60601-1 sense) were 'critical components'. Because of the allergic reaction to 'economic context' (as written in 2012 D.6.3) and the move to documenting that risks are 'as low as possible', I am afraid that I now see some cracks of daylight between certain lines of risk analysis and consensus standards established to address those specific risks.

I am still in agreement with the quoted text, and I doubt that a NRTL would go looking for lines of risk analysis for areas where they have established test methods/requirement. I would recommend that the risk files include those lines of analysis (done in a consistent manner with other lines) specifically for those users who will be coming into the risk file for some other reason that certification testing to 60101-1.
 

hornet456

Starting to get Involved
#19
Hi Hornet,

I'm in the same shoes as you were 9 months ago! A test lab in Korea is requesting to see all clauses from 60601-1 included as a risk in our risk management file. We have already included all the clauses from 60601-1 as design inputs and generically covered electrical hazards by complying to 60601-1.

The requested action seems redundant. Would you be able to share any advice about how you managed the situation?

Thank you kindly. I've also sent you a PM.
I responded to your PM, hope that helps!
 

Peter Selvey

Staff member
Super Moderator
#20
I might have used this example before: take a simple component like an appliance inlet, and experts could write a small book on all the design aspects which make it safe. There's a whole lot more there than the average electrical engineer would have thought. The point is that it's not just a matter of spilling ink, it's beyond the typical medical device manufacturer's ability to even know that such a range of risks (hazardous situations) even exist.

Strictly speaking, referencing a standard as a risk control measure is not correct. The risk control measure is the actual design features that ensure compliance with the standard; the test in the standard is just the verification component. For example, if a device is likely to be splashed with water in normal use, referring to the IPX2 test is not a risk control measure, it's the gaskets, sealing, clever location of the vents and other features that form the risk control measure. With that in mind, it quickly becomes obvious that we can't document every safety related design feature in risk management. Even a simple M3x10mm screw holding the case together is a risk control measure.

As popularised by Sir Isaac Newton: "If I have seen further it is by standing on the shoulders of Giants" - in risk management much of the risk is hidden in the "giant" which is in the form of well established, safe, reliable technology, which is completely useless and even counter productive to try and document in risk management. Occasionally, innocent, youthful auditors or NRTL engineers might pick out a tiny example of a well established risk control from somewhere deep in armpit of the giant. But unless you are going to document the whole giant, what is the justification for documented that one example? It's a grain of sand on a large beach.

It's the kid standing on the shoulders of the giant that needs much more attention ...
 
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