DANSK DSF/FPREN 60601-1-12 PDF

1.1 * Scope This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended by their MANUFACTURER for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1. NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use. NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can also be intended for use in other environments, for example, in a professional healthcare facility. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1. NOTE 3 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical sources and outdoor environmental conditions.