Have you tried to understand this requirement???
– Page 35 –
60601-1-2 © IEC:2001(E)
*****
*36.202.1 GENERAL
*d) Non-medical electrical equipment
Non-medical electrical equipment that is supplied as part of
a SYSTEM and the use of which in the SYSTEM can be reasonably
expected not to affect the ESSENTIAL PERFORMANCE or safety of
the SYSTEM if the non-medical electrical equipment exhibits
DEGRADATION, is exempt from the IMMUNITY testing requirements
of this standard, provided the non-medical electrical equipment
complies with applicable international IMMUNITY standards.
(For example see CISPR 24 for ITE and IEC 61326-1 for
measurement, control and laboratory equipment.) The
determination of reasonable expectation not to affect the
ESSENTIAL PERFORMANCE or safety of the SYSTEM shall be based
upon a risk analysis. This risk analysis is not required if
the non-medical electrical equipment supplied as part of a
SYSTEM is tested for IMMUNITY in accordance with 36.202.
*****
Here is my analysis of this requirement.
The first sentence, when reduced to subject-object-verb is:
Non-medical electrical equipment is exempt from the
immunity testing requirements.
The provisos are:
*if the equipment is supplied as a part of a system;
AND
*if the equipment degrades, the degradation does not
affect:
-the essential performance of the system, or
-the safety of the system;
AND
*if the equipment complies with applicable international
immunity standards.
Then, a separate statement on determination of degradation:
Degradation of
-essential performance or
-safety
shall be determined by risk analysis.
There is an orphan proviso statement to the degradation
statement:
Risk analysis is not required:
*if the equipment is supplied as a part of a system that
has been tested for immunity.
This last statement is a "get-out" for the risk analysis.
This risk analysis "get-out" raises some questions:
If risk analysis is not required, then does this imply no
degradation of essential performance or safety? If this
is true, then the second "if" statement is satisfied.
But, the equipment should still comply with the third
"if" statement, namely that the equipment must comply
with immunity standards. So, does the equipment need to
comply with immunity standards both as a stand-alone and
as part of a system?
Worse still, the equipment is NEVER exempt from immunity
testing -- which was the original statement! The
statement boils down to:
The equipment must either be tested alone or
as a part of a system.
*****
Absolutely terrible writing! I once had a professor
who said if you can't write clearly, then you probably
don't understand clearly.
Best regards,
Rich
Gary Stuyvenberg wrote:
> I am looking for help in understanding what the following paragraph from
> IEC 60601-1-2
> (Medical Electrical Equipment) means and the extent to which it
> applies...........for example,
> a PC with medical software installed on it. Thanks in advance.
>
> Gary
>
>
> – Page 35 –
> 60601-1-2 © IEC:2001(E)
>
> *36.202.1 GENERAL
> *d) Non-medical electrical equipment
> Non-medical electrical equipment that is supplied as part of a SYSTEM
> and the use of which
> in the SYSTEM can be reasonably expected not to affect the ESSENTIAL
> PERFORMANCE or
> safety of the SYSTEM if the non-medical electrical equipment exhibits
> DEGRADATION, is
> exempt from the IMMUNITY testing requirements of this standard, provided
> the non-medical
> electrical equipment complies with applicable international IMMUNITY
> standards. (For example
> see CISPR 24 for ITE and IEC 61326-1 for measurement, control and
> laboratory equipment.)
> The determination of reasonable expectation not to affect the ESSENTIAL
> PERFORMANCE or
> safety of the SYSTEM shall be based upon a risk analysis. This risk
> analysis is not required
> if the non-medical electrical equipment supplied as part of a SYSTEM is
> tested for IMMUNITY
> in accordance with 36.202.
>
> EOM
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