E-Medic Silence TP 2 User Manual page 9

Collateral standard: Safety requirements for
Medical electrical systems
– 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.
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