Regulatory and Safety Standards for Medical Device with Measuring Function

N

nikolaos

#1
Hello,
Are there any particular standards for "Medical device with measuring function" or EU directives, FDA reccomendations or is required only IEC60601-1 compliance?

Thank you
Nikolaos
 
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Peter Selvey

Staff member
Super Moderator
#2
There is no general standard dedicated to "measuring devices" as such. There are a lot of particular standards for individual devices like thermometers, NIBP, ECG etc. Many, but not all, are in the 601 series.
 
N

nikolaos

#3
There is no general standard dedicated to "measuring devices" as such. There are a lot of particular standards for individual devices like thermometers, NIBP, ECG etc. Many, but not all, are in the 601 series.
So if the measured parameter is not covered by any standard what should be done? Is it enough to compare the measured value with a Lab instrument?
Thank you
 

Peter Selvey

Staff member
Super Moderator
#4
In regulations, there is usually a basic requirement that any claim of performance (including accuracy of a measurement function) must be verified in both design and regular production. You should meet these requirements even if there is no standard. The requirements can be found in Europe, Australian, Canadian, Japanese and US regulations, as well as in ISO 13485.

For example, in Europe, MDD Annex I, item 3:
"The devices must achieve the performances intended by the manufacturer ...".
Items 4 and 5 then refer to this performance not being adversely affected by conditions of normal use, transport and storage.

The 601 series is not really designed to reflect this basic requirement. The approach of the standard is risk based, which is of course highly subjective. For example, many manufacturers claim their device has no "essential performance". Even particular standards which cover measurements functions tend to be selective in the functions checked.

For me the main mistake in the standard is not to come out and say clearly: "this standard does not necessarily provide evidence of achieving performance as claimed by the manufacturer. Although not covered by this standard, it may be a regulatory requirement".
 
N

nikolaos

#5
Thank you for all information, but my problem remains. How the manufacturer can verify the declared performances in the case of physiological parameters measurements? If the instrument meassures a voltage the value can be compared with that of a calibrated voltmeter, but in case of blood saturation or PO2 measurements or other physiological parameters is it enough the comparison with a commercial available instrument? I can't see any other way to do it.
 

Peter Selvey

Staff member
Super Moderator
#6
The gold standard would be clinical tests on real patients, and this is actually required in many standards. For example standards for SpO2 measurements, thermometers, NIBP require that accuracy claims are validated on real patients. Bench testing may also be required but that is not enough.

There are special cases (e.g. ECG) where bench testing is enough. But it depends on the nature of interface with the patient, and in particular the ability to simulate the clinical environment.
 
N

nikolaos

#7
You are perfectly right, but even during clinical tests on real patient the measured values must be verified with a reference instument that is widely accepted from the medical community. Is this correct?
 

Peter Selvey

Staff member
Super Moderator
#8
Very much a case by case. For example ISO 80601-2-61 for pulse oximeters states that:

"The standard reference for the SpO2 ACCURACY as read by PULSE OXIMETER EQUIPMENT shall be traceable to SaO2 values obtained from CO-OXIMETER analysis of simultaneously drawn arterial blood"

In other words they want a real blood sample.

For NIBP they allow comparison to another NIBP instead of invasive measurements (but I wonder why, since NIBPs are not very accurate ...).
 
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