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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. Due to these reasons the approval procedures for medical electrical equipment and systems have become recently even more complex than they already were prior to the effective release of the latest version of the IEC 60601-1 solution possibilities with plastic housings in order to fulfil the specific requirements stated in the IEC 60601-1.
Mathias Wuttke, ODU (on behalf of Telerex)
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