thirdplanet
Registered
Hello, I look forward to many great discussions on this forum. I wish I had known about it years ago!
I am an electronics engineer and have been through the process of getting a new device through 60601 safety and EMC testing a few times.
But now I am involved with a very small startup company in the USA, and in addition to the safety and EMC, I am responsible for generating the risk analysis/management paperwork, which I have not had to do in the past projects. I might be able to delegate it to a junior engineer if I know exactly what needs to be done, but its a bit new to me.
I like to know why I am doing what I am doing, even if its somewhat academic. So in this case, I'd like to know where the actual requirement to follow IEC 60601-1 comes from.
From what I've researched I think it goes:
21 CFR (Federal law)
has a 8xx section which directly lists our device type
In that section, says that an approved consensus safety standard must be applied, of which, 60601-1 is one of them.
I've noticed some 8xx sections directly mention 60601.
Is that correct? I'd really like to know exactly what the linkage is. I would make an assumption that exactly what "version" of 60601-1 to follow depends a bit on company/marketing strategy as far as where the device will be sold, is that true?
What is the difference if my device did not have its own "subcategory" 8xx section, what would I follow then? Is there a generic section which acts as a catch all?
Or what if my device technically has a subcategory, but its under a main category that would not apply? For instance, there is an "Anesthesiology" upper category with 8xx subcategories that describe our device very well, however our device is not Anesthesiology related in any way. Would we still use those 8xx categories that seem to describe it?
I am an electronics engineer and have been through the process of getting a new device through 60601 safety and EMC testing a few times.
But now I am involved with a very small startup company in the USA, and in addition to the safety and EMC, I am responsible for generating the risk analysis/management paperwork, which I have not had to do in the past projects. I might be able to delegate it to a junior engineer if I know exactly what needs to be done, but its a bit new to me.
I like to know why I am doing what I am doing, even if its somewhat academic. So in this case, I'd like to know where the actual requirement to follow IEC 60601-1 comes from.
From what I've researched I think it goes:
21 CFR (Federal law)
has a 8xx section which directly lists our device type
In that section, says that an approved consensus safety standard must be applied, of which, 60601-1 is one of them.
I've noticed some 8xx sections directly mention 60601.
Is that correct? I'd really like to know exactly what the linkage is. I would make an assumption that exactly what "version" of 60601-1 to follow depends a bit on company/marketing strategy as far as where the device will be sold, is that true?
What is the difference if my device did not have its own "subcategory" 8xx section, what would I follow then? Is there a generic section which acts as a catch all?
Or what if my device technically has a subcategory, but its under a main category that would not apply? For instance, there is an "Anesthesiology" upper category with 8xx subcategories that describe our device very well, however our device is not Anesthesiology related in any way. Would we still use those 8xx categories that seem to describe it?