IVD Laboratory Blood Processor - Applicable standards? IEC61010-1, -2-101?

B

bluecurve

#1
Hi there,

this is my first post here, after many years of dipping 'in and out' of the forum. Great Forum - very impressed with the quality of dialogue here (and a big thanks to all who hang out here).:agree1:

Firstly apologies if this is in the wrong place - I'm specifically looking for advice on IEC61010 and related IVD and pathology lab equipment standards, but there does not appear to be a specific group for this?

To cut to the chase:
I'm currently working with a diagnostics technology company that is developing a blood separation technology that concentrates particular types of cells from a patient blood sample supplied in a small test tube (already drawn from patient = no patient contact for the device).

The device semi-automatically separates out the target cells and concentrates them in a second collecton tube. The separated cells are then taken and analysed using a variety of standard analysers including PCR based units.

I like to think of it as a printer sized box that "pre-processes" the sample before analysis by other techniques.

So now I'm trying to figure out the applicable safety test standards for this unit. It is mains powered and contains a couple of different pumps, tubing and test sample tubes. It is controlled by a PLC.

Target markets for the development included USA and EU at this stage.

So far I'm thinking:
IEC61010-1 - pretty certain of this one
IEC61010-2-101 - the IVD standard, the scope of this has me wondering - if this thing is a "product for general laboratory use" then it is out of scope but on the other hand the thing is effectively at least an accessory for an IVD analyser so maybe - thoughts here please. (I'm currently thinking it's in scope)
IEC 61326-1 - EMC - positive on this one
IEC 61326-2-6 - EMC for IVD -as per the -2-101 above, could be in could be out - comments? (again I think this is in.)

IEC 61010-2-081 - Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes - I don't have any experience with this standard, nor a copy of it - has anyone worked with this one? From the scope on the IEC webstore:

"This part 2 applies to automatic and semi-automatic laboratory equipment for analysis andother purposes.
Automatic and semi-automatic laboratory equipment consists of instruments or systems for
measuring or modifying one or more characteristics or parameters of samples, performing the
complete process or parts of the process without manual intervention. Equipment forming part
of such a system is within the scope of this standard.
Examples of equipment within the scope of this standard include:
- analytical equipment;
- automatic sampler (pipettor, aliquoter);
- equipment for sample replication and amplification."

So that one sounds pretty much like a shoe in.

Risk management is as per ISO14971.​

Apologies for the information bombardment, but I wanted to give a reasonable amount of background to best focus any responses to this.

To recap, my questions are:

1) Do you think IEC61010-2-101 and IEC61326-2-6 are applicable in this application?
2) Is IEC61010-2-081 applicable and does anyone out there have experience with this particular standard?
3) Are you aware of any other safety test standards that are likely in scope for this application that I should be considering.​

Thanking you all in anticipation!!:)

BlueCurve​
 
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Marc

Hunkered Down for the Duration with a Mask on...
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#2
A quick "Bump". Can anyone help with this one? My Thanks in advance!
 
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