Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025) (Endorsed by Asociación Española de Normalización in January of 2026.)

This standard establishes specific safety and performance requirements for medical electrical equipment used in the treatment of sleep apnea. It focuses on the fundamental safety and essential performance aspects of such devices, ensuring they meet necessary technical specifications. The standard covers design, construction, and operational criteria to guarantee the reliability and safety of these medical devices. It also includes testing procedures and performance evaluation methods to verify compliance with the specified requirements. The document provides guidance on the application of general safety standards to specialized medical equipment. It is intended for use by manufacturers, regulatory authorities, and other stakeholders involved in the development, assessment, and use of sleep apnea treatment devices.