BS EN ISO 14971:2012, BS EN 62366:2008 and BS EN 15223-1:2012 Questions

[renenatasha]

Hi fellow clovers!
First and foremose, Happy New Year to all.

I've some doubts concerning some BS EN standards and I couldn't think of a better way to get help, other than seeking the expertise of my fellow clovers here. Just a brief info: our company produces medical devices to be sold in US and EU.

1. BS EN ISO 14971:2012 (Deviation #3: ALARP vs AFAP)
- We're using a template for our RMF. The definition for "ALARP" as per ISO 14971:2007 is still considered acceptable. But as for EN ISO 14971:2012 is concerned, can we associate ALARP with AFAP? (meaning whichever risks that fall under AFAP are considered as ACCEPTABLE - provided we?ve given all means of risk reduction that we could think of)

2. BS EN 62366:2008
- We've been told by our Technical File's reviewer that not having this will cause us to have a major NCR.
- Since this is something new for us. We currently don?t have an SOP for this. Do we need one solely for this or can we incorporate it in our RMF procedure?

3. BS EN 15223-1:2012
- A feedback from our recent Technical File review, we were told that the "Single Use Only" symbol is insufficient to state that product is Not For Reprocess. And since I can't find any "Non-reprocessable" symbol in the standard, will the use of both "Single Use Only" and "Do Not Resterilize" constitute to the meaning?

Thanks in advance, guys! Have a blessed week ahead!

 

[renenatasha]

BS EN standards

Hi fellow 'covers'!
First and foremost, Happy New Year to all.

I'd like to seek your help concerning some doubts I have over BS EN standards and I couldn't think of a better way to get help, other than seeking the expertise of my fellow 'covers' here. Just a brief intro: our company produces medical devices to be sold in US and EU.

1. BS EN ISO 14971:2012 (Deviation #3: ALARP vs AFAP)
- We're using a template for our RMF. The definition for "ALARP" as per ISO 14971:2007 is still considered acceptable. But as far as EN ISO 14971:2012 is concerned, can we still associate ALARP with AFAP? (meaning whichever risks that fall under AFAP are considered as ACCEPTABLE - provided we’ve given all means of risk reduction)

2. BS EN 62366:2008
- We've been told by our Technical File's reviewer that not having this (in the ER) will result in a major NCR.
- Since this is something new for us, we currently don’t have an SOP for this. Do we need one solely for this or can we incorporate it in our RMF procedure?

3. BS EN 15223-1:2012
- A feedback from our recent Technical File review, we were told that the "Single Use Only" symbol is insufficient to state that product is Not For Reprocess. And since I can't find any "Non-reprocessable" symbol in the standard, will the use of both "Single Use Only" and "Do Not Resterilize" constitute to the meaning?

Thanks in advance, guys! Have a blessed week ahead!

 

[SteveK]

Re: BS EN standards

2. BS EN 62366:2008
- We've been told by our Technical File's reviewer that not having this (in the ER) will result in a major NCR.
- Since this is something new for us, we currently don?t have an SOP for this. Do we need one solely for this or can we incorporate it in our RMF procedure?

As per my RMF I just use a template for Useability (not an SOP) for my TF.
Have a look at this post for an example:

http://elsmar.com/Forums/showthread.php?p=400541#post400541


And yes I would expect a NC if it is not included - my NB has been OK with the form of the above example with recent TFs submitted for approval.

Steve

 

[Pads38]

You mention that your Notified Body has stated that missing out 62366 would be a Major NC. But remember that ALL use of standards is voluntary. What is compulsory (for EU) is to show that the Essential Requirements (Med Device Directive Annex 1) have been met. However, the use of standards is often the most straightforward way to show compliance.

Can the usability requirements of the MDD be shown just by risk management? Probably. Depends on the complexity of your device and how significant usability is to safe use.

But..
If you want to be able to claim compliance with EN 60601-1 then the collateral parts of that have to be included. So that would include EN 60601-1-6, the Usability standard. That it turn demands that a .."usability process in accordance with IEC 62366 has been undertaken." So it is difficult to sate unconditional compliance with 60601-1 without already having 62366 in place.

This situation does make things difficult, especially for products that have been on the market for some time, so they do not have the usability design process documents that 62366 demands. Over on the 62366 sub-forum there is news (from Marcello) of the development of another IEC standard to specifically address legacy devices, but this is still a couple of years (at least) away.

 

[Marcelo]

Over on the 62366 sub-forum there is news (from Marcello) of the development of another IEC standard to specifically address legacy devices, but this is still a couple of years (at least) away.

Just a heads-up, althought the revision of IEC 62336 (creating IEC 62366-1 and IEC 62366-2) will take some years, JWG will publish an amentment to the original IEC 62366 which is the annex detailing how to deal with legacy devices in the following months (probably May/June 2013)

 

[rob73]

3. BS EN 15223-1:2012

- A feedback from our recent Technical File review, we were told that the "Single Use Only" symbol is insufficient to state that product is Not For Reprocess. And since I can't find any "Non-reprocessable" symbol in the standard, will the use of both "Single Use Only" and "Do Not Resterilize" constitute to the meaning?"

MDD states (13.3 (f)) that "where appropriate, an indication that the device is for single use. A maufacturer's indication must be consistent across the community", so using the symbol (which is globally recognised) should not be a problem, BUT the MDD also states (13.6 (h)) that IFU must include "information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be reused"
Maybe this was what they where querying?
Some authorities (FDA is one I think) also that require you to show the symbols used on packaging in the IFU with a description, so for the single use symbol you could have the descriptions "single use/do not reuse/do not reprocess"


.

 

[renenatasha]

Thanks, Pads38.
Actually, the feedback came from another consultant. Our very own NB didn't spot the missing EN 62366 standard in our ER (Essential Requirements) checklist. However, we're using EN ISO 14971 to show conformance. In another word, we're addressing the questions in Annex E of EN 62336:2008 in our Risk Analysis. Wouldn't this suffice?

Gee... you mean there's this EN 60601-1-6 that needs to be in place too? Oh dear - spare me the gallows please! I guess I'm gonna give EN 60601-1 a skip if it's an option.

Anyway, thanks for the info. - Rene

 

[renenatasha]

Thanks, Rob!

I guess that's what we're missing. We assume that "Do not reuse" symbol is pretty obvious that device is for single use and no reprocessing is allowed. Well, I guess it won't hurt to elaborate that in our IFU too. BUT what about product that doesn't have an IFU (e.g Class I and IIa)? Does that mean we have to include that statement on the label?

Again, thanks for your help. - Rene

 

[ET_Marley]

Marcelo

Thank you for the information regarding the amendment of 62366 covering legacy systems. I had heard about this amendment and it is much needed.

How is the revision of 62366 progressing? are you still looking for comments about what the revision should bring?

Thanks

Marley

 

[Marcelo]

How is the revision of 62366 progressing? are you still looking for comments about what the revision should bring?

The first CD of IEC 62366-1 was circulated and comments were sent. The group will revise the comment and make changes for the circulation of a CD in the next meeting of TC 62 (in April in Shanghai).

And not, I'm not looking for comments anymore, that was before the development of the working draft, were the comments could be incorporated into the document if they were reasonable. We are past this stage now.