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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