"Potential" Essential Performance in IEC 60601-2-54 (Definition)

ltcmff

Starting to get Involved
#1
the word"potential" has been added before"essential performace" in IEC 60601-2-54 1.1rd.
what is the purpose for the word?
 
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Marcelo

Inactive Registered Visitor
#2
I don't have the full text here, but the draft I've got show:

201.4.3.101 * Additional ESSENTIAL PERFORMANCE requirements
Amend the title:

69 201.4.3.101 * Additional potential ESSENTIAL PERFORMANCE requirements
I don't remember seeing this in other standards, but I know what might be the problem.

A lot of people think that the essential performance defined in particular standards is the "only" essential performance requirement. This is wrong. IEC 60601 requires that the manufacturer follows a process to define essential performance. What particular standard do is to show some essential performance that was identified during the development of the standard. The manufacturer still has to follow the procedure to identify essential performance, and the ones defined in the standard may (because they really depend on the device characteristics) be the outputs of the process. So, in this way, the essential performance defined in any particular standard is a "potential"essential performance.
 

ltcmff

Starting to get Involved
#3
thank you for your reply.
that is to say that the essential performance defiened in the particular standards may be not the essentail peformance of the device depending on the risk mangagement rusults?

for example, the accuracy of loading factors ,if the manufacture dose not regard it as essential peroformance through the identifying procedure ,is this compliant with the particular standard ?
 

ltcmff

Starting to get Involved
#4
thank you for your reply

from your interpretation ,that is to say the essential performance defined in the particular standards may not the essential performance of device if the manufacuter does not regard it as essential performance by following their indentiying procedure., am i right?
 

Marcelo

Inactive Registered Visitor
#5
that is to say that the essential performance defiened in the particular standards may be not the essentail peformance of the device depending on the risk mangagement rusults?
Depending on the device design, in fact.

for example, the accuracy of loading factors ,if the manufacture dose not regard it as essential peroformance through the identifying procedure ,is this compliant with the particular standard ?
It's not a "regard", you have to follow the procedure to evaluate essential performance.

In the case of 203.6.4.3.103, the requirement is (at least in the draft I've got) "For HIGH-VOLTAGE GENERATORS operating with AUTOMATIC INTENSITY CONTROL in RADIOSCOPY, continuous indication of the LOADING FACTORS that vary shall be given at the CONTROL PANEL."

IN this case, if the equipment does not operate with AUTOMATIC INTENSITY CONTROL in RADIOSCOPY (a design feature), it obviously does cannot have this essential performance (meaning, after manufacturer follow the process, it won't include this item).

In the case of 203.6.5 Automatic control system, if the equipment is not for indirect radioscopy, it obviously does cannot have this essential performance (meaning, after manufacturer follow the process, it won't include this item).
 

ltcmff

Starting to get Involved
#6
even if the quipment operate with AUTOMATIC INTENSITY CONTROL in RADIOSCOPY, but the asseemnt results of essential performance maybe not include the essential performance, is this purpose of "potential"?

may i have your email address?

thank you.
 

Marcelo

Inactive Registered Visitor
#7
even if the quipment operate with AUTOMATIC INTENSITY CONTROL in RADIOSCOPY, but the asseemnt results of essential performance maybe not include the essential performance, is this purpose of "potential"?
No, as I mentioned, it seems to be related to the design feature. If the equipment does operate with AUTOMATIC INTENSITY CONTROL in RADIOSCOPY, you would not be able to conclude that the essential performance mentioned by the standard is not essential performance because if you follow the procedure to determine essential performance, in practice it would include the essential performances mentioned (besides any other essential performance identified by the application of the procedure, if any).
 

ltcmff

Starting to get Involved
#8
ok, i got it.
another quesiton is that different committe maybe have different opinion for defining the essential performance.
for example, accuracy of loading factors are essential performance in iec 60601-2-54, but why not inclued in IEC 60601-2-44?
leakage radiation is essentiaol performance in IEC 60601-2-1, but why not inclueded in IEC 60601-2-44 and/or IEC 60601-2-54.
in my opinion, leakge radiation is basic safety.
 

Marcelo

Inactive Registered Visitor
#9
Yes, there's a lot of inconsistencies between different working groups dealing with particular standards regarding essential performance. Unfortunately, there's really nothing that can be done at this moment to solve the problem.

This may be solved in the next edition of IEC 60601. TC 62 is meeting this week in Germany (unfortunately I could not attend) to decide the future of the IEC 60601 series. The general expectation is that the work of Amendment 2 for IEC 60601-1 will begin, and the work on the 4 edition will also begin. Hopefully several problems which include the inconsistencies with essential performance can be solved with the new series (however, the target date for the publication of the new series is 2024, so it will take a while).
 
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