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– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility; Requirements and tests
Accessory equipment connected to the analog
and digital interfaces must be in compliance
with the respective nationally harmonized IEC
standards (i.e. IEC 60950 for data processing
equipment, IEC 60065 for video equipment,
IEC 61010-1 for laboratory equipment, and
IEC 60601-1 for medical equipment.)
Furthermore all configurations shall comply with the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system, and is therefore, responsible that the system
complies with the requirements of the system standard IEC 60601-1-1. The unit is for
exclusive interconnection with IEC 60601-1 certified equipment in the patient
environment and IEC 60XXX certified equipment outside of the patient environment.
If in doubt, consult the technical services department or your local representative.