IEC 60601-1 Impact test on glass touch controller

#1
Hi,

We are designing a portable medical device with a glass face which has two separate subareas: a) the display area and b) the touch controller/buttons area.

According to the IEC 60601-1 standard, the display area should be excluded from the 15.3.3 Impact test.

"The test is not applied to flat panel displays, to the platen glass of ME EQUIPMENT (for example
film scanners), or to cathode ray tubes (see 9.5.2)."

We also interpret that the "platen glass" term above includes the whole glass face of our device including the touch controller area.

Could you please confirm if the total glass face should be excluded from this test?

Thanks.
 
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Marcelo

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#2
It's difficult to answer such questions without a knowledge of the device.

But please bear in mind that:
- Product standards usually have requirements to deal with specific hazards/risks;
- Tests are usually ways to verify implementation and efficacy of risk control measures;
- Standards are usually voluntary;
- What you have to comply with is usually the mandatory regulatory requirements.

In your case, I would ask - what is the problem (hazard/risk) here? What should I do to prevent the problem? What should I do to show that I included a control to prevent the problem?
 
#3
Hello Marcelo,

Thank you for your response.
I understand that a risk-based approach shall be used in order to select the appropriate pass/fail verdict of the impact test.

Please let me rephrase the question.
If we ask a test-lab to perform the 60601-1 impact test, can we specifically request them to avoid hitting the glass area of the enclosure (display+control pannel) when they perform this test, as the standard states "The test is not applied [...] to the platen glass of ME EQUIPMENT"?
Independently of the outcome and risk.
Thanks.
 
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