Class II medical devices represent around 43 percent of all the medical devices cleared for use by the U.S. Food and Drug Administration. Class II medical devices should be tested for electrical safety by the manufacturer during development with standards produced by the International Electrotechnical Commission, or IEC.
Class II
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
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
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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