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Hello,
I have HF surgical Medical equipments in which have peak working voltage of 3kV, as per Table 6 of IEC 60601-1 3rd Edition we have to give 10 kV isolation.
Where as IEC 60601-2-2 clause 201.8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP): It writes that
" For HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES, separation between the HF APPLIED PARTS and the ENCLOSURE including SIGNAL INPUT PARTS and SIGNAL OUTPUT PARTS and between different HF PATIENT CIRCUITS need not be subjected to the dielectric strength test of 201.8.8.3"
This is supported by Subclause 201.8.5.1.2 – MEANS OF PATIENT PROTECTION (MOPP), which says:
"These reduced requirements are considered to be adequate because the "voltages stressing the insulation..." are of HIGH FREQUENCY and therefore, if insulation fails between the HF APPLIED PARTS and the ENCLOSURE, the RISK is much lower than at lower frequencies".
So my query is - Seeing both the clauses my interpretation is that we can avoid the insulation of 10kV for HF surgical equipment which is suggested in general standard. Is this the correct interpretation?
Regards,
indorewalep
I have HF surgical Medical equipments in which have peak working voltage of 3kV, as per Table 6 of IEC 60601-1 3rd Edition we have to give 10 kV isolation.
Where as IEC 60601-2-2 clause 201.8.5.1.2 * MEANS OF PATIENT PROTECTION (MOPP): It writes that
" For HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES, separation between the HF APPLIED PARTS and the ENCLOSURE including SIGNAL INPUT PARTS and SIGNAL OUTPUT PARTS and between different HF PATIENT CIRCUITS need not be subjected to the dielectric strength test of 201.8.8.3"
This is supported by Subclause 201.8.5.1.2 – MEANS OF PATIENT PROTECTION (MOPP), which says:
"These reduced requirements are considered to be adequate because the "voltages stressing the insulation..." are of HIGH FREQUENCY and therefore, if insulation fails between the HF APPLIED PARTS and the ENCLOSURE, the RISK is much lower than at lower frequencies".
So my query is - Seeing both the clauses my interpretation is that we can avoid the insulation of 10kV for HF surgical equipment which is suggested in general standard. Is this the correct interpretation?
Regards,
indorewalep