CENELEC - EN 60601-1-12
Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
|Publication Date:||1 May 2015|
|ICS Code (Medical equipment):||11.040|
Medical practice is increasingly using MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for monitoring, treatment or diagnosis of PATIENTS in the EMERGENCY MEDICAL SERVICES ENVIRONMENT (see 3.1). The safety of MEDICAL ELECTRICAL EQUIPMENT in this uncontrolled, rough environment is a cause for concern.
This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for MANUFACTURERS of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and for technical committees responsible for the development of particular standards.