Essential performance and EMC immunity testing

david316

Involved In Discussions
#1
Hello,

If a particular standard defines essential performance as providing therapy above limit X or generation of a technical alarm, and in the same particular standard, under electromagnetic disturbances addition general requirements section (typical 202.8.1.101) the standard states,

"The device may exhibit temporary degradation of performance (e.g. deviation from the performance indicated in the instructions for use during IMMUNITY testing) that does not affect BASIC SAFETY or ESSENTIAL PERFORMANCE".

Is it acceptable during EMC immunity testing that the device fails to deliver therapy above limit X but the device raises a technical alarm?

Thanks a lot of any input!
 
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Benjamin Weber

Trusted Information Resource
#3
If the particular standard does define the EP only as "output shall not exceed limit X", this has to be passed during the EMC testing in my oppinion.

Other particular standard explicitely say "value shall not be below/above limit X OR an alarm shall be raised". Regarding the EP of the x-ray output I think the alarm is not sufficient, because the x-ray output can lead to severe harm of the patient in very short time. Alarms for degradation of EP usually are OK for performances, where after the alarm is raised the operator can act quickly in order to prevent the potential severe/catastrophic harm.
 

david316

Involved In Discussions
#4
Thanks. In this case the committee have defined EP as providing therapy above limit X or generation of a technical alarm. Given the definition of EP, one would assume that if you meet this EP the risk is acceptable. One would also assume that an alarm is required in order to make the risk acceptable if the device fails to deliver therapy above limit X.

But, the test regarding EMC immunity is worded vaguely. It states...

"The device may exhibit temporary degradation of performance (e.g. deviation from the performance indicated in the instructions for use during IMMUNITY testing) that does not affect BASIC SAFETY or ESSENTIAL PERFORMANCE".

My understanding is EMC immunity testing is considered a "normal condition". So if during EMC immunity testing the device fails to provide therapy above level X but alarms, and this is considered a PASS as EP is still maintained, doesn't this imply it is acceptable to fail to deliver therapy as long as you alarm under "normal conditions"?
 
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