The IEC 60601-1 states maximum requirements concerning the protection from electric shock for medical applications in which patients and operators can get into direct contact with electrical equipment and systems. In order to reduce risks to a minimum, manufacturers must integrate two means of protection in their products.
For this purpose, they can either implement two separate measures or apply a single measure twice. Overall the specified protection level 2 MOPP (means of patient protection) or 2 MOOP (means of operator protection) must be obtained. In addition, manufacturers must introduce a management process in which they not only investigate all protection-relevant aspects, but also document the results in detail. Due to these reasons the approval procedures for medical electrical equipment and systems have recently become even more complex than they already were prior to the effective release of the latest version of the IEC 60601-1.
