IEC 60601 vs. IEC 61010 - CE Mark for our IVD medical device

We are in the process of doing a gap analysis for getting a CE Mark for our IVD medical device which is currently cleared in the US. One question that came up is which electrical safety standard we need to be following. For the US, we comply with 60601. For Europe it seems like there is a separate standard for IVDs - 61010. Can anyone confirm this?

Thanks.

Re: IEC 60601 vs IEC 61010

It appears that ISO/IEC 60101 may be more for medical devices, while ISO/IEC/UL/CSA 61010 is for laboratory equipment.

Best bet is to find a CB Scheme recognized lab and talk to them. Examples in North America are SGS, UL, CSA, ITS, and I suspect others as well.

Hope this helps.

According to the scope, IEC 60601-1 is only for medical devices with patient contact, this may include some IVD devices where the sample is taken using the same device (such as home use blood sugar level testers).

However, for the vast majority of IVDs the patient is well removed, and hence IEC 60601-1 is not applicable. The correct standard is IEC 61010-1, and any particulars that apply to your device.

There is persistent and incorrect use of IEC 60601-1 for anything that is electrical and medical because of the title of the standard. The scope itself which refers to patient contact are buried inside the standard.

The FDA complicates this, because IEC 60601-1 is listed as a recognized consensus standard, while IEC 61010-1 is not. Thus, many feel more comfortable using IEC 60601-1 in the US even though it is not the correct standard.

In Europe, you will definately have to use the correct standard: IEC 61010-1 and any particulars that are applicable.

According to the scope, IEC 60601-1 is only for medical devices with patient contact

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Just to correct the information a little, IEC 60601-1 is for electrical medical devices, let´s say it this way, which have patient contact (applied parts by the definition of the standard), or transfer energy to or from the patient or detect this transfer (which means the equipment really does not have to contact the patient).

Still, IVDs devices, as you say, generally do not fit this scope.

Product Safety in Medical Device

Hi All
I am trying to compile the Product Safety standard and testing requirements for Medical Devices. Would appreciate knowing if any of you have any presentation or reference materials on the above.

Thanks

Hello All,

I am working on a IVD medical device. The device is an implantable pressure measurement. The implant communicates with the reader device via RFID means. I would like to know what standards will apply to the reader device antenna. The antenna is in contact with skin. Is IEC 60601 an appropriate one or should I also explore IEC 61010.

Thank you,
Ram

Thanks everyone for your input. I’m working with a client that manufactures a product that heats water in which a heat pad is placed. After the heat pad has warmed up, the heat pad is removed and placed on the patient. Should the product be compliant to 60601-1, or 61010-1? It does not come in direct contact with the patient, but the heat pad it warms up does contact the patient. I’m in contact with Intertek and they are telling me 61010-1, but I’m not quite sure that’s correct. Also my client tells me that some competitors products are 60601-1 compliant, while other competitor products are 61010-1 compliant.

Dvangogh said:

Thanks everyone for your input. I’m working with a client that manufactures a product that heats water in which a heat pad is placed. After the heat pad has warmed up, the heat pad is removed and placed on the patient. Should the product be compliant to 60601-1, or 61010-1? It does not come in direct contact with the patient, but the heat pad it warms up does contact the patient. I’m in contact with Intertek and they are telling me 61010-1, but I’m not quite sure that’s correct. Also my client tells me that some competitors products are 60601-1 compliant, while other competitor products are 61010-1 compliant.

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I think the distinction here is whether the water heater is designed to be used with the device that has the heat pad (which I am assuming is itself is a medical device and complaint with 60601). If the water heater is designed to be used with the heat pad device (or with these types of medical devices), it would be classified as an accessory to a medical device, and regulated in the same was as a medical device itself would be (e.g. by following 60601). If it is not intended to be used with a heat pad device, it would not be classified as an accessory to a medical device (for example, a domestic microwave 'could' be used to heat up a heat pad device, but since it is not explicitly designed to do so by the manufacturer, it will not be regulated as a medical device).

The definition of a medical device accessory in the MDD is

an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device

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I suspect the same applies with regards to why some similar products are complaint with 61010 (e.g. they are accessories to devices that are themselves complaint with 61010, as opposed to 60601), although someone else may have to clarify that.