Contactless Hospital Bed Sensor Certification

M

maxishev

#1
Hello all!

We are working on bed sensor that can be put at the bottom side of the bed and that able to measure heart rate, respiration rate and some other parameters of patient who is lying on the bed. There are no any contact between sensor and patient/operator. The sensor itself work from 5V DC that it get at his input. The 5V produced from external power supply of 220V that we ordered and that have simple certification of CE. The sensor also have battery for back-up when grid is no available, that can be recharged from input 5V supply. The measured data transferred from the sensor to Mobile phone/tablet via BLE or to special data server via Wi-Fi wireless connection.

Now we want to make to this sensor IEC 60601 certification.

Is it possible to make IEC 60601 certification for sensor that I described above? Although the sensor no have straight contact to patient/operator - at some point the contact can be possible - for example patient fall at floor and somehow touch the sensor at bottom of bed. So according to subclause 3.8 it can be defined as APPLIED PART and need to make all the tests that need to be done to APPLIED PART. Our sensor don't have metal parts at it packing. The problem is that at our sensor we don't have earth pin. The sensor receive only 2 pins - 5V and GND and earth pin may be available only at power supply - the part that we buy and that need to make certification itself. Is the power supply must be earthed? As the sensor itself receive only 2 pins - 5V and GND.

But anyway I am a little confused what tests we should to do? We maybe need to make IEC 60601 certification to power supply and sensor together as one product. Or find suitable power supply with all needed certifications and only need to do certification tests to sensor itself. And what are those tests? Except some tests like short-circuit of 5V and GND and see if this no cause hazard situations. Are we need to do hort-circuit to all components at our board to check is it no make hazard situations? To charger, to booster DC-DC converter, to buck DC-DC converter? Also we need to make thermal and humidity tests as described at the document. Also need to make radio safety tests. What else?

Thank you in advance for your response
 
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Peter Selvey

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#2
Under Clause 3.8 it is only parts that must (necessarily) contact the patient which make applied parts.

There is a separate clause 4.6 which deals with parts that could contact the patient, but your case would struggle to fit in there as well (it is really intended for parts like cables of a sensor that are not applied parts but could reasonable contact the patient in normal use).

So, strictly your device does not fall under IEC 60601-1. But, you could use the standard for reference (there are still many reasonable requirements e.g. essential performance, waterproofing etc), but there would be no applied part, MOPP etc.

If you want certification, you would have to negotiate with your test agency first. Often they allow out-of-scope application for IEC 60601-1 because it is seen as a more strict standard, but you need to check first.
 
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