Information on IEC 60601-2-101 for IVDs - Has it been superseded?

[Marcelo Antunes]

In re-reading it after the thought I've been giving to when to use which testing standard, it occurs to me that there may well be cases of a widget being both a medical device and a piece of medical laboratory equipment depending on which "hat" it is wearing. A blood glucose measuring device is one such example. A patient can use it in the home (medical device) or conceivably a laboratory could use it to check glucose in blood samples collected from patients (laboratory equipment). So maybe it's a matter of marketing / intended end user. If you want to sell to both, you have to test to both standards.

Nope. Sorry, maybe it wasn´t clear on the other thread.

The problem here is, does the device touch the patient, or transfer energy to the patient, or monitor the transfer? Is so, it´s a medical electrical equipment under the definition of IEC 60601.

If not, it´s an electrical medical device under IEC 61010.

So, if the device is for home use but does not touch the patient (for example, it uses a previous sampled blood sample) then it´s not a medical electrical equipment, and would be an electrical medical device under IEC 61010 (the term "laboratory equipment" in the description of IEC 61010 does not refer only to equipment used on laboratories)

[bluecurve]

Hi there,

Long time reader, occasional contributor...

If the device is a SMBG meter for home use (Self Monitoring Blood Glucose = patient use, self test), then the primary standard that applies is ISO15197

This specifies both the performance testing, labeling, IFU and clinical requirements for SMBG's. It also calls out IEC61010-1 and -2-101 for safety and IEC61326 (and the -101) for EMC.

Yes even though the test strip contacts the patient...

I agree that SMBG's are one of those "borderline" applications, but given the size of the industry and user base (and the overall well being that comes from having SMBG's), I'm not surprised they have their own standards. Skeptics may claim industry pressure, I can't comment on that

By way of reference I have been involved in the past in product engineering for SMBG's and bringing one major product line in this space to market.

regards,

BC