scope:

This Standard applies to the safety of medical electrical equipment. Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety. Safety hazards resulting from the intended physiological function of equipment covered by this Standard are not considered. Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text. The object of this Standard is to specify general requirements for the safety of medical electrical equipment and to serve as the basis for the safety requirements of Particular Standards. This particular Standard applies to HEART-LUNG-MACHINES (HLM) as defined in 2.104, hereinafter referred as HLM.