IEC 60601-1-2: Medical Electrical Equipment - Collateral standard: Electromagnetic compatibility...
IEC 60601-1-2 is a collateral standard that applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards.
This edition of IEC 60601-1-2 was revised to structurally align it with the 2005 edition of IEC 60601-1 and to implement the decision of IEC subcommittee 62A that the clause numbering structure of collateral standards written to IEC 60601-1:2005 would adhere to the form specified in ISO/IEC Directives, Part 2:2004. The principle technical changes are in Clause 4, which now recognizes that there is a general requirement for a risk management process in IEC 60601-1:2005.
The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. This standard complements IEC 60601-1 and applies to all medical devices.
IEC 60601-1-2 is useful for the protection of safety services, other medical electrical equipment and systems, non-medical electrical equipment (e.g. computers), and telecommunications (radio/TV, telephone, radio-navigation).
Emissions Testing
Modes that maximize emissions
Consider active and standby modes
Immunity Testing
Standby mode should be considered
Devices not rated for continuous use and use a duty cycle
Product Configuration for Testing
All cables, tubing, and fluid containers necessary for the intended use must be attached and full, including system grounds when present
Artificial hand circuit (220 pF + 510