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IEC 60601-1 - RS232 Connector Requirements - Female Connectors question

Roland chung

Trusted Information Resource
#1
Hi all,

Recently, the test house told me that the female RS232 connector mounted on our equipment is not recommended, a male RS232 connector which the pins can not be touched directly is more reasonable. However, I can not find any relevant requirement in IEC 60601-1 does not allow the female connector provided that the connector meets the clause 16 a)5) and 16 e).

Please kindly advise it, thanks.
 
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Marcelo

Inactive Registered Visitor
#3
Maybe they were thinking about 56.3 e) (which does not seem the case).

Anyway, I would be in principle againt connectors with pins touchable without the use of a tool because they would have to pass all requirements for accessible parts.
 

Roland chung

Trusted Information Resource
#4
The female connector surely meets the requirement of 56.3 since such SELV connector complies with 17 g)4). It seems no technical reasons to reject female connector.
 
Last edited:

Marcelo

Inactive Registered Visitor
#5
Sorry, i tried to say that 56.3 c) is not applicable in this case (no conductive connection to a patient).

And, if it was applicable, it would not pass, because the pins can be directly touched.

Anyway, i think that maybe this was the wrong interpretation of your test house.

What was their justification for that? You mentioned reccomentation, does not seem a requirement to me.
 

Roland chung

Trusted Information Resource
#6
Yes, the test house did not use "MUST", but "strongly recommend". It seems they would not compromise. They also do not have reasonable explanation. One just felt the connector with pins can be touched without the aid of tool is not safety enough. Most products are employed male connector.
 
S

Shine Zhang

#7
I think it's irresponsible of saying "strongly recommend" without any reasonable explanations.

some explanations may come as below:

1.It reduces the probability of the operator touching the contacts of the male connector and the patient simultaneously. even if the saied construction complied with 16e.

2. avoiding unneccessary electro-static discharge on your device through such male connector, which may influence the reliability and quality of the product.

3. if it is a low-signal equipment, avoiding contacing internal circuit through such male connetor is reasonable or desirable.

4.....
 

Peter Selvey

Staff member
Super Moderator
#8
As mentioned, any connector located on the rear of the device is normally exempted from leakage and isolation requirements based on Clause 16e.

But, it may not be immediately apparent that this exemption is necessary for both male and female connectors, as most female connectors do not comply with isolation requirements such as 3.4mm creepage. If the exemption is not applied, the internal circuits must be treated as live and tested for double insulation (typically 500Vdc, 3.4mm).

So a test house that insists a male connector fails while a female connector passes would appear to have some more explaining to do.
 

Roland chung

Trusted Information Resource
#9
I am sorry for the editorial error. The correct statement shall be male RS232 connector mounted on our equipment. My question is if male connector can be accepted when such male connector meets clause 16 e)?

Actually, either male connector or female connector does not meet the 3.4 mm creepage. It is unreasonable to consider any SELV connector as hazardous live part since such connector has nothing to do with the patients.

Peter, I can not understand your point very well. Could you explain in detail?
 

Peter Selvey

Staff member
Super Moderator
#10
Just to clarify first: we may be mixing male and female. A male connector is normally the one that has directly accessible pins; a female connector is usually not accessible but the spacing is very small (e.g. ~1mm).

My thinking was that the test house "fails" the male connector because the pins are accessible. However, to be consistent they should also "fail" the female connectors, as a spacing of ~1mm is also not enough.

Actually the 2nd edition is very messy on this point. Strictly, both male and female connectors do not comply with Clause Clause 17g (see the compliance statement, 2nd paragraph, which allows shorting of any cr/cl below limits).

The exclusion under 16a)5) still requires basic insulation, which most connectors do not have (male or female). And the exclusion in 16e)1) requires a cover, which again most connectors do not have.

However, the principle is that if contact with the patient is unlikely, then they can be excluded. Most test labs understand this and quietly consider signal connectors excluded under 16e)1). This quiet exclusion should apply to both male and female connectors.

This area has been fixed in the 3rd edition. Clause 8.4.2 c) sets up the basic exclusion (using risk management), and specifically refers to contacts of connectors, whether male or female.

The flow from 8.4 to requirements in the standard is:
8.4 --> 8.7 (leakage currents), and
8.4 --> 8.5 (MOP) --> 8.8 (dielectric strength, cr/cl)

Therefore, once the basic exclusion is set up under 8.4.2 c), the part is exempt from all tests for leakage, dielectric strength and cr/cl.

So to summarize:

Male and female connectors formally fail the 2nd edition, but it is industry practice to accept under 16e;

Male and female connectors pass the 3rd edition, provided location is such that direct or indirect contact with the patient is unlikely (e.g. rear of the device).
 
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