S
Hi all,
In 3rd edition, the standard requires that except for PERMANENTLY INSTALLED ME EQUIPMENT, the ME EQUIPMENT is to be tested with and without the PROTECTIVE EARTH CONDUCTOR connected.
However, the rationale of 8.5.5.1 states that NORMAL USE includes the situation that a PATIENT is defibrillated while connected to the EQUIPMENT and, at the same time, the OPERATOR or another person is in contact with the ENCLOSURE. The possibility of this occurring at the same time as the SINGLE FAULT CONDITION of a defective PROTECTIVE EARTH CONNECTION is very unlikely and is therefore disregarded.
From mentioned above (especially the phrase underlined), it seems that the rationale conflict with the requirement. I am confused that whether the PROTECTIVE EARTH CONDUCTOR interrupted when conducting the defibrillation test for class I equipment (NON-PERMANENTLY INSTALLED).
Please kindly advise it. Thanks in advance.
In 3rd edition, the standard requires that except for PERMANENTLY INSTALLED ME EQUIPMENT, the ME EQUIPMENT is to be tested with and without the PROTECTIVE EARTH CONDUCTOR connected.
However, the rationale of 8.5.5.1 states that NORMAL USE includes the situation that a PATIENT is defibrillated while connected to the EQUIPMENT and, at the same time, the OPERATOR or another person is in contact with the ENCLOSURE. The possibility of this occurring at the same time as the SINGLE FAULT CONDITION of a defective PROTECTIVE EARTH CONNECTION is very unlikely and is therefore disregarded.
From mentioned above (especially the phrase underlined), it seems that the rationale conflict with the requirement. I am confused that whether the PROTECTIVE EARTH CONDUCTOR interrupted when conducting the defibrillation test for class I equipment (NON-PERMANENTLY INSTALLED).
Please kindly advise it. Thanks in advance.