Information on IEC 60601-2-101 for IVDs - Has it been superseded?

JeantheBigone

Quite Involved in Discussions
I'm seeing a lot of references to "IEC 60601-2-101, Safety Requirements For Electrical Equipment for Measurement, Control, and Laboratory Use - Part 2" in 510(k) summaries for IVDs, but am having trouble finding any info on this standard. Has it been superceded? Incorporated elsewhere?

Thanks in advance to Covers who can provide any insight.
 

Marcelo

Inactive Registered Visitor
Re: Information on IEC 60601-2-101 for IVDs - Has it been superceded?

You are refering to another standard, 61010-2-10, not 60601-2-101.

The 61010 series is for measurement, control and laboratory equipment - including, for example, IVDs which are not medical electrical equipment.

61010-2-101 is being revised at the moment to align with the third edition (2010) of 61010-1.
 

JeantheBigone

Quite Involved in Discussions
Thanks for your quick answer.

I was able to find information on BS EN 61010-2-101 Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for in vitro diagnostic (IVD) medical equipment http://www.techstreet.com/cgi-bin/detail?doc_no=bs_en|61010_2_101_2002;product_id=1117024
(not sure why my search wasn't working on the computer I was using)

This is in reference to blood glucose monitors for home use so I am not sure how 61010-2-10 would apply:. Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials.

At any rate it looks like I am back on track - thanks for the help!
 
R

raymond02302

IEC 61010-2-010 is for lab equipment with function heating material. Apparently, it is not applicatble to equipment you concerned.
In addition, for blood glucose monitors for home use, IEC 61010-2-101 and ISO 15197(for performance) are applicable.
 
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Marcelo

Inactive Registered Visitor
Sorry, I meant 61010-2-101, just a typo.

Regarding blood glucose monitors, please take care that, depending on how your equipment performs the measurement, it can be either a medical electrical equipment under IEC 60601 or a electrical medical device under 61010.

Also, if you are using the new edition of the general standard IEC 61010-1, you cannot use it together with the edition of IEC 61010-2-101, which is aligned with the old general standard.
 

JeantheBigone

Quite Involved in Discussions
This is a small handheld device intended for patient use (OTC) using glucose oxidase which uses a change in conductivity of a fluid following a chemical reaction of the patient's blood with a strip.

FDA/CDRH doesn't specify whether to use 60601 or 61010 anywhere in the guidance documents or review criteria as far as I can tell. About the only specific info I can find is this in a draft document:

"Manufacturers are encouraged to study the effect of environmental factors such as temperature, humidity and altitude as well"
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094134.htm

So far all of the summaries I've read though reference both the 60601 and 61010 standards. I get the impression that the 61010 in conjunction with ISO 15197 is applicable but applicants are also doing 60601-1-2 either over and above the requirements or because nothing in the 61010 series is in the recognized list of consensus standards whereas the 60601 series is.
 

JeantheBigone

Quite Involved in Discussions
Thank you for pointing out that thread. I had seen it but now I see it differently. :frust:

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.
 

Marcelo

Inactive Registered Visitor
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)
 
B

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
 
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