IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirements

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petruchio

Hi

Sub-clause 8.3.1 of this standard states that MEE (Medical Electrical Equipment) shall provide protection to at least IP21 but sub-clause 7.2 seems to allow a get-out here by permitting marking the product with the umbrella/raindrops symbol if it fails to meet the water ingress requirements.

Does this get-out only apply to products with a carrying case or is it generally applicable?

petruchio
 

Stijloor

Leader
Super Moderator
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

A Quick Bump!

Can someone help?

Thank you very much!!
 

Pads38

Moderator
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

My reading of that would suggest that the minimum requirement is IP21, but that may be provided by the enclosure and a carrying case in combination, but only when the device is intended to only be used with the case.

The rationale for 8.3.1 in Annex A is useful.

The requirement for IP21 is, I guess, driven by the higher likelihood of liquid spills and general misuse. There is additional requirements in clause 5 for Accessible Parts (smaller finger used to judge what an accessible part is).
 
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petruchio

Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

Thanks for this. The standard is appallingly worded, the get-out statement in sub-clause 7.2 being an isolated paragraph which makes no reference - implicitly or explicitly - to anything other than the enclosure.

My company has been making light therapy equipment for many years and this standard renders the non-LED products obsolete at a stroke. However, the sub-syndromal variant - Winter Blues - can continue to use these products so long as they are not represented as medical devices. It's an absurd situation. For once I'm thankful of ISO14971 which can apply common sense here.

petruchio
 

Peter Selvey

Leader
Super Moderator
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

Yes, the text of 7.2 conflicts with 8.3.1, it's a mistake in the standard that will need to be rectified. There are a number of other cases of outright and provable mistakes in IEC standards (for example, the alarm standard IEC 60601-1-8, and all of the ECG standards like 601-2-25) so it's not completely uncharted territory.

Further, there is a reasonable argument to say that having a minimum requirement of IPX1 is excessive as a general requirement, taking into account the number and nature of electrical devices typically used in the home. That is, if it's required for medical, it should be required for a lot of other electrical devices, and there really is not the market data to support this.

It's also worth to note that a "true" IPX1 rating is not just a matter of wiping the water off and doing a dielectric strength test. Rather, IEC 60529 says the water " ... shall not ... interfere with the correct operation of the equipment ... ".

There is expected to be a range of medical equipment where the water would not cause any problem for basic safety (shock/fire) but could easily interfere normal operation such as sensors or getting into battery compartment or secondary electronics. Even though basic safety is OK, it fails IPX1.

One manufacturer of home use blood pressure meters found that IEC 80601-2-30, which clearly refers to home use equipment, does not specify that IPX1 or better is required. They pointed out that a particular standard (-2-30) overrides the collateral (-1-11), and concluded that the IPX1 test was not applicable. It's a kind of fudge, but gets to a reasonable result.

As always, modern regulation does not require compliance with standards. However, you do need to carefully document and justify any cases where you do not comply with a standard, even if it appears, as in this case, that the standard in fault.
 
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flyingfrisbee

Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

To piggyback on this thread,

I was wondering if testing is required to declare an IP rating. If so, what kind of in-house or external testing would be required for say IP53?

Take care,

Friz
 

Marcelo

Inactive Registered Visitor
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

I was wondering if testing is required to declare an IP rating. If so, what kind of in-house or external testing would be required for say IP53?

You can declare without testing, but if you need to prove it, you need to test it. Tests for IP ratings are defined in IEC 60529.

Some general info can be found for example here: (broken link removed) and here https://www.google.com.br/url?sa=t&rct=j&q=&esrc=s&source=web&cd=7&ved=0CG0QFjAG&url=http%3A%2F%2Fwww.eaton.com%2Fecm%2Fidcplg%3FIdcService%3DGET_FILE%26allowInterrupt%3D1%26RevisionSelectionMethod%3DLatestReleased%26Rendition%3DPrimary%26dDocName%3DBR00305001E&ei=TYdoU_W2L6_jsASj9YLQDg&usg=AFQjCNGAQMfnpnC7OXb7_IAONE-At6mPow&sig2=QPxD8-YBz1trC9X_5X3y9g&bvm=bv.66111022,d.cWc&cad=rja
 
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flyingfrisbee

Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

In what situation would you need to prove an IP rating?

Would CE marking a device be one of those cases?

How about for infant phototherapy equipment located under the patient?

IEC 60601-2-50
"If INFANT PHOTOTHERAPY EQUIPMENT is located under the PATIENT it shall at least comply with
IPX3 specified in IEC 60529."
 
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Smoks

Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

Hello,

I would need to get back to the question of the IP rating and the 60601-1-11. And i hope you have a suggestion or solution to overcome my problem.
My company produces antidecubitus mattress for many years. They are medical device and are composed by an electrical device hung up to the bed. They passed all the mechanical tests except for the IPx1. I?m struggling now with the certification body to find a solution. The test for IPx1 seems a bit excessive, considering all the electrical equipment used in the domestic environment and if I have to think the worst case for my device is that an old man drop accidentally a glass of water on the device and not a shower for 10 mins?
One solution could be re-project the enclosure, but it?s the most onerous and it?s not acceptable for now.
As it was proposed and interpreted by the certification body, the other solution should be provide the enclosure with a carrying case that provide the protection against ingress of water but?
As some of you have already wrote in previous posts, the paragraphs 7.2 and 8.3.1 conflict and the 7.2 could be bit interpreted or am I wrong? Our device doesn?t have any carrying case and the sub-clause 7.2 reports that if the enclosure doesn?t provide the minimum required degree protection shall be marked ?keep dry?.
If it?s a question of interpretation why it can not be read in this way? So add what it?s needed in the user manual and in the risk analysis and label the enclosure ?keep dry??
Apparently this is not possible.
Do you have any suggestion to overcome this problem? Do you know any get-out solutions to this?
Any help is more than welcome! Thanks a lot
Monica
 

Peter Selvey

Leader
Super Moderator
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

It may not fix the situation in the short term, but I suspect that IEC 60601-1-11 will be amended eventually.

One problem as pointed out is that an IPX rating is not normally found on most household products, which is definite proof that the requirement is unreasonable. It may be appropriate for certain types of products, but not as a general requirement. In Europe, unreasonable requirements can be challenged under the "principle of proportionality". The regulators in Europe may be slow but they will almost certainly get around to deleting this requirement if the IEC insists on keeping it.

A second problem is the meaning of an IP rating. Until now, test labs in the medical area have treated such a rating as a kind of abnormal condition. However the correct meaning for an IP rating (as per IEC 60529) is that the equipment can work normally during the ingress condition. Think of an aquarium heater or outdoor Christmas lights.

Most medical devices are unable to meet this criteria. A few are, such as an body worn infusion pump designed to work in the shower, but most would have sensors and other functions and features that don't work when wet. Even a touch screen display does not work so well in rain and it can register false events.

In amendment 1, this original meaning has been highlighted. Essential performance (in normal condition) shall not be affected by the test. And in IEC 60529-1 there was always the requirement for the test not to interfere with normal operation of the equipment.

So, if the standard IEC 60601-1-11 forces an IP rating, but the nature of the device is such that the equipment cannot work while wet, then we have a stalemate.

Possibly in the future we may have an abbreviated test as has been included in some particular standards, for example 30s rainfall, external water removed after test, considered an abnormal condition so essential performance in normal condition is not required.

In the mean time, it makes sense to allow the manufacturer to use the "keep dry" mark as a way of avoiding the IP test in general.

As always, the risk management file should back up that the absence of an IP rating is reasonable given the nature of the device. Manufacturers should consider if abbreviated tests (e.g. 30s) are still appropriate. Test labs should review risk management file for plausibility in this area, if the keep dry symbol is used.
 
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