Class II Device Electrical Safety
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Class II
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Medical devices placed in the class II category are commonly used electrical devices, including powered wheelchairs and some pregnancy test kits. Other class II devices include implantable radiofrequency devices that contain patient identification and health information.
Safety
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Before class II devices can be cleared for use in the United States, manufacturers of these devices must test them electrically so that they comply with IEC 60601-1. This standard refers to the general safety requirements for medical electrical equipment.
Standards
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Each device tested under IEC 60601-1 must provide a list of the standards tested for customer information. These standards can replace, update or delete the requirements of IEC 60601-1 when specific to the device tested.
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