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

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iec 60601 - medical electrical equipment, ingress protection, medical device electronics and electrical equipment
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  Post Number #1  
Old 6th March 2013, 01:55 PM
petruchio

 
 
Total Posts: 26
Please Help! IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirements

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

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  Post Number #2  
Old 7th March 2013, 02:22 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 14,974
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

A Quick Bump!

Can someone help?

Thank you very much!!
Thanks to Stijloor for your informative Post and/or Attachment!
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  Post Number #3  
Old 7th March 2013, 05:24 AM
Pads38

 
 
Total Posts: 585
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).
Thanks to Pads38 for your informative Post and/or Attachment!
  Post Number #4  
Old 7th March 2013, 06:06 AM
petruchio

 
 
Total Posts: 26
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
  Post Number #5  
Old 8th March 2013, 09:08 AM
Peter Selvey

 
 
Total Posts: 804
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.
Thank You to Peter Selvey for your informative Post and/or Attachment!
  Post Number #6  
Old 6th May 2014, 12:18 AM
flyingfrisbee

 
 
Total Posts: 17
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
  Post Number #7  
Old 6th May 2014, 02:57 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 2,711
Re: IEC 60601-1-11 - Medical Electrical Equipment IP (Ingress Protection) Requirement

Quote:
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: http://www.specfast.com.au/media/dow...ystem_ip53.pdf and here http://www.google.com.br/url?sa=t&rc...,d.cWc&cad=rja
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #8  
Old 7th May 2014, 12:40 AM
flyingfrisbee

 
 
Total Posts: 17
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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