Applicability of IEC TR 60601-4-2 for disposable parts

FelipeSchneider

Involved In Discussions
Hello all,

We are developing a device that has a part sensitive to ESD. Interestingly, this part is also disposable, and we are aiming to apply for a 510(k) clearance from the FDA.

I understand that the FDA requires compliance with IEC TR 60601-4-2 for ESD testing, which demands Performance Criteria B. This criterion is described as:

The ME EQUIPMENT or ME SYSTEM should continue to meet the performance criteria after the following tests, without the need for operator intervention.

Given this, my question is: Does our device fail the test if the disposable part fails to meet Performance Criteria B?
From your experience, is there a way to justify such a failure?

All the best, FS.
 

Martin A

Registered
Hi Felipe,

Two thoughts on this:

1. Do you claim that Essential Performance is maintained to 60601-1-2 when the EUT breaks?

2. Which test levels are you applying when you are experiencing destructive failure? IEC TR 60601-4-2 uses 4 kV contact and 8 kV air discharges, as opposed to 8/15 kV for -1-2.

In general Performance Criterion B means that (e.g.) measurement values are allowed to be outside of the acceptance criteria during the test, but should return to "normal" after the test. "Without the need of operator intervention" prohibits hitting a reset or similar and replacement of parts (disposable or not) is not allowed for Criterion C either, in my experience.

Hope this is of some help,
Martin
 

FelipeSchneider

Involved In Discussions
Hi Martin, answering your questions:
1. Do you claim that Essential Performance is maintained to 60601-1-2 when the EUT breaks?
The device does not have an EP as defined by the 60601-1, but the all-point of the IEC TR 60601-4-2 is to avoid manufacturers claiming that the device does not have an EP which would allow the device to stop working or breaking at the smallest sign of disturbance, at least this is my point of view considering the experience that I have dealing with FDA reviewers that support their requests based on the FDA EMC Guidance for Medical Devices.
2. Which test levels are you applying when you are experiencing destructive failure? IEC TR 60601-4-2 uses 4 kV contact and 8 kV air discharges, as opposed to 8/15 kV for -1-2
I haven't applied any yet, but I believe that the device will stop working until the disposable part is replaced when discharges below 4 kV are applied.
 

Jaydub

Involved In Discussions
Is an ESD warning label feasable on the part in question?

IEC 61000-4-2, 8.3.2

"Unless stated otherwise in the generic, product-related or product-family standards, the
electrostatic discharges shall be applied only to those points and surfaces of the EUT which
are accessible to persons during normal use. The following exclusions apply (i.e. discharges
are not applied to those items):

...
e) those contacts of connectors or other accessible parts that are ESD sensitive because of
functional reasons and are provided with an ESD warning label, for example, r.f. inputs
from measurement, receiving or other communication functions."
 

FelipeSchneider

Involved In Discussions
That is our main alternative in the case of a failure @Jaydub, I was just concerned that the lab or FDA would complain, but seems that we should be able to justify/reason our way around it.
Many thanks.
 
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