New EMC IEC60601-1-2 4.0 Ed. Requirements

N

nikolaos

Hi All,

I try to understand the IEC60601-1-2:2014 4.0 Ed. new requirements and I have started a gap analysis for some of our ME.

According IEC60601-1-2:2014:
Annex I ? immunity PASS/FAIL criteria can specify degradations that are acceptable because they do not result in unacceptable RISK? and also ?the ME passes the test if it continues to provide its BASIC SAFETY and ESSENTIAL PERFORMANCE?

According the Risk Management of our ME there are NO ESSENTIAL PERFORMANCES of a clinical function, other that related to BASIC SAFETY, where loss or degradation beyond the limits specified results in an unacceptable RISK.

Does this mean that whatever happens during IMMUNITY test, the test is PASS if the ME continues to provide BASIC SAFETY?

Checking with the 2014/30/EU EMC Directive:
?When placing their apparatus on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Annex I. :

Equipment shall be so designed and manufactured, having regard to the state of the art, as to ensure that:


(b)it has a level of immunity to the electromagnetic disturbance to be expected in its intended use which allows it to operate without unacceptable degradation of its intended use.

These are the FUNCTIONAL PERFORMANCES but the IEC60601-1-2:2014 4.0 Ed. refers only to the ESSENTIAL PERFORMANCES which is quite different.


Example:

If during the ESD test (16KV) the display becomes black or gets broken, the test is PASS for IEC60601-1-2:2014 if the ME continues to provide its BASIC SAFETY but FAIL according the 2014/30/EU EMC Directive.

What is missing me? What is the correct interpretation?


Thanks in advance
 
Stijloor

Stijloor

Leader
Super Moderator
Re: EMC IEC60601-1-2 4.0 Ed. New Requirements

A Quick Bump!

Can someone help?

Thank you very much!!
 
N

nikolaos

Re: EMC IEC60601-1-2 4.0 Ed. New Requirements

No help or any comments? The 4.0 Ed. is very recent and there is no much experiance with test labs.
Thanks
 
W

wally4u

I'm somewhat hesitant to classify any medical device with "no essential performance", but if your NB accepts that (ours doesn't) great :eek:!

The way I would read the MDD section would that if you can reasonably expect any EMC interference you should shield your device in such a way that it will function appropriately as stated in the intended use.

So your example would be correct, you can pass the 2-40 but still fail the MDD requirements.
 
N

nikolaos

A ME must not necessaty have "essential performances", it depends on the type of the ME and what is an "unacceptable risk" for the manufacturer.

Regarding the 4.0 Ed., to define the pass/fail criteria to the EMD one must follow the MDD and not the 4.0 Ed.!! Something is missing here.
 
B

Bryce S

My first thought is that the EMC Directive is not needed - you are exempt under the MDD. As long as your test results match what you specify as pass/fail, then you pass. It will be up to your NB to accept or not.

Is your NB asking for 4th ed EMC already? I don't even see it in the EU OJ list of Standards.

good luck...
 
C

cdewitt

It is difficult for me to believe your product has no ?Essential Performance?. That is essentially saying it does nothing. You need to ask the question what is the medical function that it performs. After you?ve answered that you ask what are the parameters it must operate on or within to do that function. You then have a function and limits that define its operation that you can use to define Essential Performance.
 
N

nikolaos

[FONT=&quot]Hi cdewitt,[/FONT]
[FONT=&quot]According the 3rd Ed. of IEC60601-1 ESSENTIAL PERDORMANCE is:[/FONT]
[FONT=&quot]"performance of a clinical function, other than that related to [/FONT][FONT=&quot]BASIC SAFETY[/FONT][FONT=&quot], where loss or[/FONT]
[FONT=&quot]degradation beyond the limits specified by the [/FONT][FONT=&quot]MANUFACTURER [/FONT][FONT=&quot]results in an unacceptable [/FONT][FONT=&quot]RISK"[/FONT]
What you consider "essential performance" in my opinion are the "functional performance" which is another story.
[FONT=&quot][/FONT]
[FONT=&quot]
[/FONT]
 
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