User manual
Version: v4.5.2
a medically certified separating transformer between the mains and the ME system will guarantee the total
touch current to stay under the required limits. Additionally, the medically certified separating transformer
also increases the means of protection regarding electric shock for the whole ME system and also for the
individual components.
5.6.3 Annex: Explanation of applied part
IEC 60601-1 uses the term ‘applied part’ to refer to the part of the medical device which come into physical
contact with the patient in order for the device to carry out its intended function.
Applied parts are classified as Type B, Type BF or Type CF according to the nature of the device and the
type of contact. Each classification has differing requirements from the point of view of protection against
electrical shock.
Type CF
is the most stringent classification, being required for those applications where the applied part
is in direct conductive contact with the heart or other applications as considered necessary.
Type BF
is less stringent than CF, and is generally for devices that have conductive contact with the
patient,or having medium or long term contact with the patient.
Type B
is the least stringent classification, and is used for applied parts that are generally not conductive
and can be immediately released from the patient.
Type B applied parts may be connected to earth, while Type BF and CF are ‘floating’ and must be
separated from earth.
Atracsys / 2020-06-17 / 16:48:00
29 / 113
