Testing Medical Equipment used in conjunction with Oxygen Rich Environments

Roland chung

Trusted Information Resource
#1
Hello folks,

Does anyone have experience in testing of medical equipment used in oxygen rich environments?

According to clause 11.2.2.1 a) 5) of 60601-1:2005, spark ignition test apparatus (figure 34) is used to determine if a source of ignition exists. I am confusing how to choose electrical parameters for test (current, voltage, capacitance, inductance or resistance). Because the circuits in practice are complex, it is not easy to decide which electrical source shown in figure 35 to figure 37 should be used.

Any thoughts will be highly appreciated.

Roland
 
Elsmar Forum Sponsor
#2
60601-1:2005 said:
NOTE 2 For ME EQUIPMENT that includes a circuit not addressed in Figure 35 to Figure 37 (inclusive), either the test voltage or current may be set at three times the worst case values with the other parameter set at the worst case value for determining whether ignition can occur.
Hope this helps.
 

Marcelo

Inactive Registered Visitor
#4
According to clause 11.2.2.1 a) 5) of 60601-1:2005, spark ignition test apparatus (figure 34) is used to determine if a source of ignition exists.

Well, just to clarify things, the spark gap test is an alternative to evaluating the limits of figures 35 to 37 (which requires that you measure I x U, U x C and I x L of your circuit and compare them to the figures). And then only if you verified if 11.2.2.1 a) 1, 2, 3 and 4 do not happen (if so, the criteria for a sourcee of ignition to exist would be met and you would not even need to evaluate 11.2.2.1 a) 5)).

So you mean you verified 11.2.2.1 a), b) , c) and d) and no one can exist (in NC and SFC) and then, for 11.2.2.1 a) 5, you cannot measure and evaluate the limits according to figures 35-37?
 

Roland chung

Trusted Information Resource
#5
11.2.2.1 a) is to determine the source of ignition. Any of a)1) to a)5) exist in NC and SFC shall be considered to be sufficient for ignition. I do not understand why we do not need to evaluate 11.2.2.1 a) 5) if verification per a)1 to a)4) has been done respectively.

Yes, it is clear that the spark test is an alternative of a)5). Since we do not have other test methods, we would like to follow this spark test.

My concern is how to use Figure 35 to 37. It would be better to give an example.
 

Marcelo

Inactive Registered Visitor
#6
I do not understand why we do not need to evaluate 11.2.2.1 a) 5) if verification per a)1 to a)4) has been done respectively.
Oh sorry, I meant to say that if you evaluate 1-4 and there's a sourrce there, you will need to verify it first. You would then need to address 5 anyway, you are right.
 

Roland chung

Trusted Information Resource
#7
Manufacturers of lung ventilators, anaesthetic systems and their associated devices (e.g. Respiratory humidifiers) would suffer from this situation.

Any thoughts?
 

Marcelo

Inactive Registered Visitor
#8
Yes, it is clear that the spark test is an alternative of a)5). Since we do not have other test methods, we would like to follow this spark test.
The "normal" evaluation of a) 5) is an assessment, not a test. If your circuit approximates the model circuits of figures 35-37, you need to calculate the worst case situations of your circuit, including safety factors, and create a model circuit of your circuit and then compare the results with the reference curves on the figures. If the resulting circuit does not pass the limits, a) 5) is ok. This is the way to use the curves on the figures.

If you prefer to test instead of relying on the comparison, you will still need to calculate the resulting circuit (worst cases + safety factors), and then perform the test using the apparatus and the resulting circuit.

And then, as the mentioned note says -
NOTE 2 For ME EQUIPMENT that includes a circuit not addressed in Figure 35 to Figure 37 (inclusive), either the test voltage or current may be set at three times the worst case values with the other parameter set at the worst case value for determining whether ignition can occur.
Regarding which circuit to use....it depends on your model circuit, you need to evaluate if your circuit is purely resistive, capacitive or inductive and then use the right one.

You can also take a look at G.5.3 * Low-energy circuits - which uses the same idea.
 
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