Medical electrical equipment. Medical diagnostic ultrasonic equipment. Technical requirements for governmental purchases

This standard establishes technical requirements for the procurement of medical diagnostic ultrasound equipment. It outlines specifications related to the performance, safety, and quality of such devices. The document covers essential aspects including functional characteristics, operational conditions, and testing procedures. It also defines criteria for evaluating the suitability of equipment for medical use. The standard provides a framework for ensuring that medical diagnostic ultrasound devices meet necessary technical and safety standards. It includes details on documentation, marking, and compliance testing. The requirements are intended to guide procurement processes and ensure consistency in the selection and application of medical diagnostic ultrasound equipment.