Medical Device Battery Powered Equipment with Battery Charger Classification

[sankui]

Dear all,

There is an issue related to ME classification. The equipment is powered by inside rechargeable battery and can not operate normally while charging by a CLASS II battery charger.

According to clause 14.5b), INTERNALLY POWERED EQUIPMENT having a means of connection to a SUPPLY MAINS shall comply with the requirements for CLASS I or CLASS II EQUIPMENT while so connected, and with the requirements for INTERNALLY POWERED EQUIPMENT while not so connected. From this point of view, it seems our equipment shall be classified as CLASS II and INTERNALLY POWERED EQUIPMENT. If so, CLASS II symbol shall be shown on the lable of equipment. Do you think it is necessary?

But the rationale of sub-clause 14.5b) states that these requirements do not apply to EQUIPMENT (including any separate power supply unit or battery charger) which is incapable of being connected to a SUPPLY MAINS and to a PATIENT simultaneously. From this point, it seems that our equipment shall only be classified as INTERNALLY POWERED EQUIPMENT because the equipment can not operate while charging. That is to say, it is not possible to connect SUPPLY MAINS and PATIENT simultaneously.

This question is not complicated, but I am a little confused. Please kindly advise it.

Thanks and regards

 

[George Weiss]

Hello,
just food for thought:
.
Battery Charger
If the device is intended for use with rechargeable batteries, we recommend that you identify the method used to isolate the user from AC line current, and that you follow IEC 60601-1, “Medical Electrical Equipment - Part 1: General Requirements for Safety” to show that the levels of patient leakage current, measured under both normal and single fault conditions, are acceptable.

from @
http :// www. fda .gov /MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm198726.htm - DEAD (404) LINK DECOUPLED

 

[sankui]

Hi george,

The battery charger is absolutely certified to IEC 60601-1. Actually, my question is relevant to the equipment classification according to clause 14 in IEC 60601-1.

Anyway, thank you all the same.

 

[Sjoerd]

It depends on how you formulate the intended use of the device.

If it is impossible to connect the patient while charging AND place the charger etc. outside the patient environment, I don't think a 60601-compliant charger is required, but a 60950-compliant charger will suffice (MOP not MOPP).
Seems to me that; while connected to the patient -> internally powered, while charging -> follow 60950 classification.

 

[sankui]

Hello Sjoerd,

Thank you for your input. I agree with your point if the product certified to IEC 60601-1:2005.

However, for IEC 60601-1:1988+A1+A2, the clause 6.8.2h) states that instructions for use shall identify power supplies or battery chargers necessary to ensure compliance with the IEC 60601-1. Therefore, medical grade battery charger required for this case.

But if you use clause 3.4 (equivalent safety) to justify the risk is so small that no hazards will occur, IT battery charger should also be accepted in IEC 60601-1:1988.

 

[Peter Selvey]

Hi Sankui,

I don't believe the requirement in 6.8.2 h) implies that a medical grade power supply is necessary.

That said, it is normally more convenient to assess the whole system to IEC 60601-1 (i.e. one report) as a medical device rather than having separate reports and requirements according to two standards, and possibly two regulations (e.g. MDD and LVD in Europe).

In that case, the "equipment" is defined as both the charger and the medical device. This equipment would be considered both Class II and internally powered. Some requirements such as patient leakage may be assessed only when the battery operated part is separate from the charger.

The symbol for Class II should only appear on the battery charger, and never on a battery powered part. While not clear in the 2nd edition, this symbol is intended for equipment having mains parts. This is clarified in the 3rd edition as the Class II marking is called out under clause 7.2.6 titled "connection to supply mains".

Note, the appropriate standard for battery chargers, if it is considered to be a separate device, may be IEC 60335-2-29 together with IEC 60335-1, rather than IEC 60950-1.

 

[sankui]

Hello peter,

Well said. But how do you understand the sub-clause 6.8.2 h)? I think that it is a clear statement.

Generally, as a manufacturer, we will purchase a recognized battery charger. Therefore, one report is expected.

Furthermore, I believe that the battery powered unit including battery charger is outside of the scope of 60601-1 while charging (no connection to patient). So the annex A stresses 14.5b) does not apply to EQUIPMENT (including any separate power supply unit or battery charger) which is incapable of being connected to a SUPPLY MAINS and to a PATIENT simultaneously.

 

[Peter Selvey]

From a purely IEC standard point of view, you are right, the charger should be considered under a different standard.

From a regulatory point of view (e.g. Europe) it depends. If the charger is custom designed for medical equipment then the charger is still a "medical device" and must comply with the MDD. However, since there is no applicable standard, standards from the IEC 60601 series could be used. The manufacturer of the charger should decide.

If the charger is not custom designed for medical use, then it must be evaluated under the LVD and the appropriate harmonised standard applied (e.g. IEC 60335 series).

From a certification point of view, it will be up to the certification agency to decide if they will accept bending the rules. I know both UL and TUV SUD occasionally applied IEC 60601-1 to equipment that did not strictly fall under the definition of "medical electrical equipment", since there was no patient interface. Common examples are X-ray and ultrasound printers and processing devices that may be in the same room as the patient but really don't interface directly. This is usually because the client strongly requests, and they in turn are responding to marketing requests.

An associated battery charger may strictly be not IEC 60601-1, but I don't think many test agencies, regulatory reviewers etc would think twice if they saw it covered by an IEC 60601-1 report.

 

[Jamiechina]

This thread help to fix my confuse to. TKS

 

[shreyas1611]

Hi all,

Our company is planning to market insulin pens, which is classified as medical devices and arebattery operated, to other countries. We all know that there are two types of insulin pens 1) desposable pens and 2)reusable pens. I need to know the approximate timeline for registering these pens (i.e reusable and desposable insulin pens) in the following countries;

1. Algeria
2. Argentina
3. Brazil
4. Egypt
5. Russia
6. Turkey

Also, I need to know whether manufacturing facility and/or final packaging facility, has to be set up in any of these countries. I tried finding it the net, but unfortunately couldnt fine any .

Thanks in advance

Shreyas Rao