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IEC 60601-1-2 applies to the Basic Safety and Essential Performance of Medical Electrical Equipment (ME Equipment) and Medical Electrical Systems (ME Systems) in the presence of Electromagnetic Disturbances and to Electromagnetic Disturbances emitted by ME Equipment and ME Systems.
60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many countries. Many companies view compliance with IEC 60601-1 as a requirement for most markets.
Class II Equipment Class II ME Equipment does not rely on basic insulation and protective earth grounding for safety. * Instead, they use additional insulation to meet two Means of Protection. This addition could be in the form of reinforced insulation and/or double insulation.
The International Electrotechnical Commission (IEC) and the US FDA developed an international standard for MR safety. IEC 60601-2-33 recognizes three modes of scanner operation: normal operating mode, first-level controlled operating mode, and second-level controlled operating mode.
EN 60601-1 Part One covers safety and essential performance for all medical electrical equipment. EN 60601-2 Part Two covers the requirements for specific product groups. Collateral Standards cover requirements on specifics for medical electrical equipment systems.
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IEC 60601-1 outlines the general standards expected to be met by all medical electrical equipment, while IEC 60601-2-XX provides particular standards which apply to specific types of medical electrical equipment. IEC 60601-1 is continually reviewed, and standards may be added or changed through amendments.
EN/IEC 60601-1-2 describes specific test methods for measuring electromagnetic compatibility (EMC) and sets limits to ensure that medical devices function reliably and do not cause dangerous interference with other devices, such as communication systems or vital equipment.
EN 60601-1-2 defines the basic and essential performance for medical equipment with regard to Electromagnetic (EM) disturbances associated with electromagnetic compatibility (EMC) emissions and immunity which the equipment manufacturer needs to show compliance with.

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