Medical Electrical Equipment Used in the Home Healthcare Environment and Standard IEC 60601-1-11
IEC 60601-1-11 is the standard for basic safety and essential performance of medical electrical equipment used in home settings to achieve conformance. If you manufacture a medical device that is designed for or intended for hospital use but could be used in the home setting and/or they are sold Nursing Home, your device need to comply with Home Healthcare Standard IEC 60601-1-11.
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