International standard for medical electrical equipment.
The IEC 60601-1:2005+A1:2012 standard was published in August 2012 and is a revised version of the basic IEC 60601-1 standard of December 2005 (European equivalent: EN 60601-1:2006+A1:2013).
It contains the general specifications for basic safety and essential performance characteristics for medical electrical equipment and medical electrical systems. The IEC 60601-1 standard applies only to devices and systems that are in direct physical or electrical contact with the patient. (Patient Environment)
The unified safety standard was developed with input from clinicians, engineers and regulators. The terminology, requirements, general recommendations, and guidelines of this safety standard are intended to be useful to manufacturers of medical electrical equipment and medical electrical systems and to technical committees responsible for developing specific standards.
The goal of this safety standard is to specify requirements that go beyond the general standard and serve as a basis for standards in the medical field.
For whom is the standard relevant?
- Manufacturers of electromedical devices and systems
- Component manufacturers of electromedical devices
- Importers of electromedical devices and systems
- Medical technicians
- IT departments in hospitals
- Distributors of electromedical devices and systems