Let's say I have a medical device which consists of augmented reality (AR) glasses with cameras that overlays information to the surgeon based on their field of view. There is no Applied Part and it is not transferring energy to or from the patient, so it does not appear it falls within the definition of ME equipment which means it would not fall within the scope of 60601-1, correct? However, I'm sure a biomedical engineering department would expect to see a compliance statement to 60601-1 to approve the device to be used in the OR. So, how do I reconcile applying the requirements of 60601-1 when it does not appear to be within the stated scope of 60601-1?
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Device not falling within 60601-1 definition of ME equipment but presumed to be ME equipment
- Thread starter jddad19
- Start date
The standard is mandatory for
With that, I would argue 60601-1 is applicable.
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
With that, I would argue 60601-1 is applicable.
Just to clarify, is the argument that visible light would be considered the "detecting such energy transfer to or from the patient" which would lead to this device falling within this definition? I was considering this as well but it seemed like a little bit of a leap to consider detection of visible light with a camera sensor to be "detection of energy transfer". But I suppose if I'm looking for a reason to make it within scope that may be the only option.
Isn't the surgeon wearing the glasses? The definition of Applied Part is "part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function" Agree with @mr9000 that 60601-1 is applicable.There is no Applied Part
Well, how do you explain 60601-2-41? ;-) Maybe your device falls under that! The exclusions may be helpful:Just to clarify, is the argument that visible light would be considered the "detecting such energy transfer to or from the patient" which would lead to this device falling within this definition? I was considering this as well but it seemed like a little bit of a leap to consider detection of visible light with a camera sensor to be "detection of energy transfer". But I suppose if I'm looking for a reason to make it within scope that may be the only option.
This particular standard does not apply to
– headlights;
– endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18;
– luminaires used in dentistry, which are covered by ISO 9680;
– luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4;
– luminaires dedicated to therapeutic purposes;
– special purpose lights with different conditions of use such as light sources intended solely for decontamination of air and surfaces, UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems;
– lights connected to surgical instruments, such as luminous retractors;
– luminaires for emergency lighting, which are covered by IEC 60598-2-22.
SURGICAL LUMINAIRES and LUMINAIRES FOR DIAGNOSIS are medical devices and not general lighting equipment.
This looks more interesting that first thought.
As Yodon mentioned, the definition of "applied part" is "part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function".
The inclusion of ME SYSTEMS here looks a bit clumsy and makes the definition hard to read due to the "or" near the end. But there is no doubt that if it is read carefully it only applies to parts that physically contact the patient. These glasses don't contact the patient, and are therefore are not an applied part.
In that case, there is only the section on energy transfer which could potentially make it ME EQUIPMENT.
So, it comes down to whether the photons of light coming off the patient are "transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT".
Common sense would argue not, as in general terms, the photons don't just land neatly on the camera lens, they go everywhere in the room. Any device in line of sight of the patient that had a medical purpose would get sucked in to such a broad definition, no matter how far away they are from the patient, and no matter if there was no physical contact.
The key point is the word "transferring": the "ing" part implies the equipment is actively involved in the energy transfer, not just passive energy transfer which will obviously occur naturally, bodies being generally hotter than the environment. The word "from" as in "to or from" is necessary to include devices that actively cool the patient, it is not intended to apply to devices passive absorbing energy from the patient via radiation, convection or conduction.
A surgical luminaire is actively transferring energy to the patient, so it makes sense to fall under the definition, and more so since surgical lights can contain risks from the intensity of the illumination.
As far as "detection" goes, the actual phrase is detection of such energy transfer. This is explicitly referring to the active energy transfer that preceded the "or", it is not just any form of detection of energy. The context here is the application to auxiliary devices that may be necessary to monitor or control any active transfer of energy to or from the patient, such as a sensor that detects X-ray energy.
So, I would say no, it's not under the scope of IEC 60601-1.
But it is a medical device, so still needs to comply with the regulations.
And, there is a potential rational for inclusion in later editions (or even adopting now, in spite of the definition), on the basis that the glasses may ultimately control the treatment by guiding the surgeon's actions, or even a robots action. In that sense, it is similar importance to a sensor that detects X-ray energy that influences the X-ray exposure, even though it may not contact the patient or directly provide any energy itself.
As Yodon mentioned, the definition of "applied part" is "part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function".
The inclusion of ME SYSTEMS here looks a bit clumsy and makes the definition hard to read due to the "or" near the end. But there is no doubt that if it is read carefully it only applies to parts that physically contact the patient. These glasses don't contact the patient, and are therefore are not an applied part.
In that case, there is only the section on energy transfer which could potentially make it ME EQUIPMENT.
So, it comes down to whether the photons of light coming off the patient are "transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT".
Common sense would argue not, as in general terms, the photons don't just land neatly on the camera lens, they go everywhere in the room. Any device in line of sight of the patient that had a medical purpose would get sucked in to such a broad definition, no matter how far away they are from the patient, and no matter if there was no physical contact.
The key point is the word "transferring": the "ing" part implies the equipment is actively involved in the energy transfer, not just passive energy transfer which will obviously occur naturally, bodies being generally hotter than the environment. The word "from" as in "to or from" is necessary to include devices that actively cool the patient, it is not intended to apply to devices passive absorbing energy from the patient via radiation, convection or conduction.
A surgical luminaire is actively transferring energy to the patient, so it makes sense to fall under the definition, and more so since surgical lights can contain risks from the intensity of the illumination.
As far as "detection" goes, the actual phrase is detection of such energy transfer. This is explicitly referring to the active energy transfer that preceded the "or", it is not just any form of detection of energy. The context here is the application to auxiliary devices that may be necessary to monitor or control any active transfer of energy to or from the patient, such as a sensor that detects X-ray energy.
So, I would say no, it's not under the scope of IEC 60601-1.
But it is a medical device, so still needs to comply with the regulations.
And, there is a potential rational for inclusion in later editions (or even adopting now, in spite of the definition), on the basis that the glasses may ultimately control the treatment by guiding the surgeon's actions, or even a robots action. In that sense, it is similar importance to a sensor that detects X-ray energy that influences the X-ray exposure, even though it may not contact the patient or directly provide any energy itself.
The crude explanation I got long ago for "how to recognize an applied part" (in an ME context) was that applied parts were things that were either designed to come into contact with a patient or could reasonable be assumed to come into contact with a patient, even if that is not how the ME devices "works". There was an underlying assumption that the patient might not recognize the difference between good/planned energy, or otherwise wouldn't know they were being exposed (because the patient is unconscious or not in control of things like X-ray emitters).
I'm guessing that the glasses aren't connect to MAINS while in use, so I can't even entertain the idea that the glasses might be set upon an patient (restrained or unresponsive).
I want to believe that a NRTL could do testing to 60601-1 with appropriate exclusions, but aside from basic safety for the wearer, and some general questions I have adjacent to "60601-1-2" concerns I don't know that you would get your money's worth from a NRTL.
I'm guessing that the glasses aren't connect to MAINS while in use, so I can't even entertain the idea that the glasses might be set upon an patient (restrained or unresponsive).
So, how do I reconcile applying the requirements of 60601-1 when it does not appear to be within the stated scope of 60601-1?
I want to believe that a NRTL could do testing to 60601-1 with appropriate exclusions, but aside from basic safety for the wearer, and some general questions I have adjacent to "60601-1-2" concerns I don't know that you would get your money's worth from a NRTL.
Thank you all for the helpful replies. I somehow missed the notifications of the later responses, thought this was a dead thread after the initial responses.
Some follow-up comments/questions:
Some follow-up comments/questions:
When you say "comply with the regulations", do you mean general FDA 21 CFR, ISO 13485, MDR, etc. regulations? Or, as others mentioned, would IEC 61010 (or other) perhaps be the alternate standard that would apply to electrical medical devices that aren't within the scope of 60601-1?So, I would say no, it's not under the scope of IEC 60601-1.
But it is a medical device, so still needs to comply with the regulations.
and some general questions I have adjacent to "60601-1-2" concerns
I have a similar concern, can we still test to 60601-1-2 if we don't consider the device to be within the scope of 60601-1? If not, what would be the equivalent EMC standard to comply with?Wouldn't regulatory bodies care about EMI/EMC (per the standards laid out in 60601-1-2)?
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