Medical electrical equipment; pulse oximeters; particular requirements

This technical specification establishes specialized requirements for medical electrical devices designed to measure blood oxygen saturation via pulse oximetry. It addresses safety and essential performance aspects specific to pulse oximeters used in healthcare settings, ensuring that these instruments operate reliably under intended conditions. The document outlines test methods and performance criteria tailored to this class of diagnostic equipment, focusing on accuracy, stability, and electrical safety in the context of patient monitoring. It serves as a reference for manufacturers developing such devices and for regulatory bodies assessing compliance within the European framework. The content covers design considerations, functional requirements, and verification procedures to support the consistent and safe deployment of pulse oximetry technology in clinical environments. By defining these technical parameters, the specification aims to maintain high standards of device performance and patient safety without extending to general requirements covered by broader normative documents.