Hello All,
Not sure if this is the best place for the question but we are a bit confused on the scope of NRTL and our options on a "device" we are bringing to market. Some background:
1. The "device" is not technically a medical device (we have a well documented justification here) but is utilized in a medical environment (hospital).
2. The "device" is very low power and utilizes an off-the-shelf 60601 certified (UL) plug-in power supply. The device is used to amplify a patients voice and is very simple (on/off, up/down on volume of voice).
A couple of questions:
1. Is my understanding that NRTL is not technically required here (for medical equipment plugged into wall with wall wart) correct? The main NRTL we have been in contact with has said it is 100% required for any electrical equipment within a workplace. I also can't come up with a legal argument upon reading the regs, but it seems from reading the forums here the general consensus is it is not required by law.
2. Because the wall-wart will have 60601 UL rating on it, is it likely that this will be sufficient for hospital purchasing departments? Has anyone had a similar scenario where the wall-wart is certified but not the device?
3. Several NRTLs have said they will allow us to test the device to 62368 for the NRTL certification since it is not a medical device. Would this, combined with the wall-wart cert be sufficient?
Just trying to work through this web of regulatory/customer requirements. We will be testing to 60601 with a non-NRTL certified lab to make sure the device is safe as it does have an applied part, but we are planning on treating that separate from the NRTL side of things. My experience has all been in non-ME devices so I'm struggling a bit here. Thanks in advance for any help/insight!
Not sure if this is the best place for the question but we are a bit confused on the scope of NRTL and our options on a "device" we are bringing to market. Some background:
1. The "device" is not technically a medical device (we have a well documented justification here) but is utilized in a medical environment (hospital).
2. The "device" is very low power and utilizes an off-the-shelf 60601 certified (UL) plug-in power supply. The device is used to amplify a patients voice and is very simple (on/off, up/down on volume of voice).
A couple of questions:
1. Is my understanding that NRTL is not technically required here (for medical equipment plugged into wall with wall wart) correct? The main NRTL we have been in contact with has said it is 100% required for any electrical equipment within a workplace. I also can't come up with a legal argument upon reading the regs, but it seems from reading the forums here the general consensus is it is not required by law.
2. Because the wall-wart will have 60601 UL rating on it, is it likely that this will be sufficient for hospital purchasing departments? Has anyone had a similar scenario where the wall-wart is certified but not the device?
3. Several NRTLs have said they will allow us to test the device to 62368 for the NRTL certification since it is not a medical device. Would this, combined with the wall-wart cert be sufficient?
Just trying to work through this web of regulatory/customer requirements. We will be testing to 60601 with a non-NRTL certified lab to make sure the device is safe as it does have an applied part, but we are planning on treating that separate from the NRTL side of things. My experience has all been in non-ME devices so I'm struggling a bit here. Thanks in advance for any help/insight!
