Hello all,
I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the site...a bit pathetic on my part I guess ...
I have spent nearly 2 days reading through the many posts on these standards to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.
First as background information, we are a North American manufacturer and our product is a stand-alone software which is considered "aids for disabled/handicapped people", per definition "2.9 medical device" Note 2 in ISO 14971:2012, and which we have classified as a Class A device under ISO 62304. We are compliant to ISO 62304 and are now in the process of implementing EN ISO 14971:2012 since we will be selling in Europe. Note that I am also familiar with the Essential Requirements in MDD 93/42, of which the relevant requirements are addressed by Annex ZA in EN ISO 14971.
My questions are as follows:
1) One of my main questions is in regards to interpreting "misuse" when assessing hazardous situations. The Medical Device Regulation, section 2.1 indicates that "The first requirement of the ‘Essential principles of safety and performance of medical devices’...when used under the conditions and for the purposes intended...they will not compromise...". So in other words, it intimates that hazards/hazardous situations should be identified and analyzed based on the intended use of the product (that's my interpretation anyhow). This is the approach we took when we defined the safety classification of our product under IEC 62304. However, ISO 14971 says that "...The manufacturer shall document the intended use and foreseeable misuse...". How far are we supposed to go in identifying misuse? For example, you can develop a prosthetic leg intended to aid with simple daily activities such as walking, but if a user then decides to go rock climbing because the prosthetic has given him a greater sense of confidence (and false confidence), then he goes and falls off the cliff because the prosthetic broke off or slipped (due to being exposed to stress beyond what it was designed for); keep in mind that proper use of the product and the intended daily activities they are intended for would be clearly described up front. This would be a misuse of the product, but, is it a misuse we need to identify during our risk analysis? We don't control what people go out and do with the aid of the product. I would like to limit ‘misuse’ to things like not properly attaching the prosthetic (and resulting consequences), and thus staying within the scope of our intended use statement. Is this acceptable?
2) We've been told by our NB that IEC 62304 is a requirement so we did it (note that this was a good ‘hand in glove’ fit for us so it was no big deal...we would have spent more time debating it than just doing it). However, it is unclear if ISO 14971 is a requirement. IEC 62304 section 4.2 says we need to have a risk management process complying with ISO 14971, however per definition "2.9 medical device" Note 2 in EN ISO 14971:2012, it indicates that there is no harmonized approach yet to devices such as ours, so it is unclear if ISO 14971 is indeed a requirement or not for "aids for disabled/handicapped people". Could anyone shed some light on this?
3) In parallel with question 2, is the approach we took in defining the safety classification of our device per 62304 correct, meaning that we only considered “when used under the conditions and for the purposes intended”, and not “misuse”? When defining our ‘intended use’ statement, we actually identified some exclusions to this, meaning we identified uses of the product which it is not intended for (for example, “does not include rock climbing” ...again, our device is a software product, so the prosthetic/rock climbing example is simply an analogy).
4) I’m a bit confused on interpreting deviations 5 & 6 in Annex ZA in 14971:2012 (and I know I’m not the only one...I read the posts ). They seem to indicate that BOTH “inherently safe design” AND “protection measures” are to be applied, ...taking into account the generally acknowledged state of the art..., and it actually says that the MDD (93/42) says that these are to be applied “cumulatively”. I don’t see in the MDD any reference that they must be applied cumulatively, because it actually says “In selecting the most appropriate solutions...”. I interpret the MDR as saying that we can still choose between either the first or second bullet (inherent design/protective measure), but 14971 seems to say that both must be applied. Am I interpreting Annex ZA correctly or not?
5) Regarding IFU and deviation 7 in Annex ZA, I realize that IFU is no longer an option in terms of a risk control measure, though in reading some of the posts you might be able to lump IFU as “adequate protection measure including alarms” with proper justification (but that's not the point of this question), but what’s not clear to me is if information to users must be disclosed for EVERY residual risk (which would be nuts). I have read much material on this and it’s still not clear. Could someone clarify?
6) Does anyone know if IEC TR 80002-1:2009 is applicable to stand-alone software? I saw a post that seem to indicate it might only be applicable to when a software product needs to be verified at the user end (example hospital network) so I’m wondering if it would add any value in our case. I’ve bought so many standards so far for this risk management stuff I’d like to avoid another one if possible.
Sorry for the long post, but any information any of you could provide would be greatly appreciated.
Thanks in advance.
I have some questions regarding interpretation of the requirements related to EN ISO 14971:2012 (I use ‘ISO 14971’ interchangeably below) and ISO 62304:2006. Note that I am fairly new to the Cove; I posted 1 question last year and couldn't even figure out how to find it again on the site...a bit pathetic on my part I guess ...
I have spent nearly 2 days reading through the many posts on these standards to make sure I didn't simply throw out questions that were answered already, and found it to be very informative, although I still have a couple of questions left over which I would greatly appreciate some guidance on.
First as background information, we are a North American manufacturer and our product is a stand-alone software which is considered "aids for disabled/handicapped people", per definition "2.9 medical device" Note 2 in ISO 14971:2012, and which we have classified as a Class A device under ISO 62304. We are compliant to ISO 62304 and are now in the process of implementing EN ISO 14971:2012 since we will be selling in Europe. Note that I am also familiar with the Essential Requirements in MDD 93/42, of which the relevant requirements are addressed by Annex ZA in EN ISO 14971.
My questions are as follows:
1) One of my main questions is in regards to interpreting "misuse" when assessing hazardous situations. The Medical Device Regulation, section 2.1 indicates that "The first requirement of the ‘Essential principles of safety and performance of medical devices’...when used under the conditions and for the purposes intended...they will not compromise...". So in other words, it intimates that hazards/hazardous situations should be identified and analyzed based on the intended use of the product (that's my interpretation anyhow). This is the approach we took when we defined the safety classification of our product under IEC 62304. However, ISO 14971 says that "...The manufacturer shall document the intended use and foreseeable misuse...". How far are we supposed to go in identifying misuse? For example, you can develop a prosthetic leg intended to aid with simple daily activities such as walking, but if a user then decides to go rock climbing because the prosthetic has given him a greater sense of confidence (and false confidence), then he goes and falls off the cliff because the prosthetic broke off or slipped (due to being exposed to stress beyond what it was designed for); keep in mind that proper use of the product and the intended daily activities they are intended for would be clearly described up front. This would be a misuse of the product, but, is it a misuse we need to identify during our risk analysis? We don't control what people go out and do with the aid of the product. I would like to limit ‘misuse’ to things like not properly attaching the prosthetic (and resulting consequences), and thus staying within the scope of our intended use statement. Is this acceptable?
2) We've been told by our NB that IEC 62304 is a requirement so we did it (note that this was a good ‘hand in glove’ fit for us so it was no big deal...we would have spent more time debating it than just doing it). However, it is unclear if ISO 14971 is a requirement. IEC 62304 section 4.2 says we need to have a risk management process complying with ISO 14971, however per definition "2.9 medical device" Note 2 in EN ISO 14971:2012, it indicates that there is no harmonized approach yet to devices such as ours, so it is unclear if ISO 14971 is indeed a requirement or not for "aids for disabled/handicapped people". Could anyone shed some light on this?
3) In parallel with question 2, is the approach we took in defining the safety classification of our device per 62304 correct, meaning that we only considered “when used under the conditions and for the purposes intended”, and not “misuse”? When defining our ‘intended use’ statement, we actually identified some exclusions to this, meaning we identified uses of the product which it is not intended for (for example, “does not include rock climbing” ...again, our device is a software product, so the prosthetic/rock climbing example is simply an analogy).
4) I’m a bit confused on interpreting deviations 5 & 6 in Annex ZA in 14971:2012 (and I know I’m not the only one...I read the posts ). They seem to indicate that BOTH “inherently safe design” AND “protection measures” are to be applied, ...taking into account the generally acknowledged state of the art..., and it actually says that the MDD (93/42) says that these are to be applied “cumulatively”. I don’t see in the MDD any reference that they must be applied cumulatively, because it actually says “In selecting the most appropriate solutions...”. I interpret the MDR as saying that we can still choose between either the first or second bullet (inherent design/protective measure), but 14971 seems to say that both must be applied. Am I interpreting Annex ZA correctly or not?
5) Regarding IFU and deviation 7 in Annex ZA, I realize that IFU is no longer an option in terms of a risk control measure, though in reading some of the posts you might be able to lump IFU as “adequate protection measure including alarms” with proper justification (but that's not the point of this question), but what’s not clear to me is if information to users must be disclosed for EVERY residual risk (which would be nuts). I have read much material on this and it’s still not clear. Could someone clarify?
6) Does anyone know if IEC TR 80002-1:2009 is applicable to stand-alone software? I saw a post that seem to indicate it might only be applicable to when a software product needs to be verified at the user end (example hospital network) so I’m wondering if it would add any value in our case. I’ve bought so many standards so far for this risk management stuff I’d like to avoid another one if possible.
Sorry for the long post, but any information any of you could provide would be greatly appreciated.
Thanks in advance.