SGS Helps Emergency Medical Equipment Manufacturers Understand IEC 60601-1-12
Manufacturers and suppliers of emergency medical service (EMS) equipment are advised to check their products comply with IEC 60601-1-12: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
Released in 2014, IEC 60601-1-12 has been adopted for the IECEE CB Scheme, an international system for mutual acceptance of test reports and certificates dealing with safety in electrical and electronic components, equipment and products. It has also been included on the US Food and Drug Ad-ministration’s (FDA) “List of Recognized Consensus Standards” and is also expected to be implemented by the European Commission, probably when it transitions to the new Medical Devices Directive (MDR) in 2020.