ISO 80601-2-61:2026

Overview

ISO 80601-2-61:2026 is an international standard that specifies particular requirements for the basic safety and essential performance of pulse oximeter equipment intended for human use. Pulse oximeters are critical medical electrical (ME) devices used to estimate arterial oxygen haemoglobin saturation (SpO₂) and pulse rate, supporting both professional healthcare environments and home or emergency care settings.

This standard applies to all necessary parts of a pulse oximeter system – including monitors, probes, and cable extenders – regardless of whether they are new or remanufactured. By aligning with IEC and ISO 80601 and 60601 series standards, ISO 80601-2-61:2026 ensures compatibility and harmonization in the essential performance and safety requirements for pulse oximeter equipment worldwide.

Key Topics

• Safety and Essential Performance: The standard delineates specific criteria to ensure that pulse oximeter equipment performs accurately and safely across various use environments, from hospitals and clinics to ambulances and homes.
• Scope and Applicability: ISO 80601-2-61:2026 targets pulse oximeters used for non-invasive measurement in humans, including supplementary accessories, and covers use cases in professional, home healthcare, and emergency medical contexts.
• Accessories and Remanufactured Products: Requirements encompass not only new but also remanufactured pulse oximeter monitors, probes, and related components, ensuring consistent quality and safety.
• Clinical Evaluation: The standard emphasizes clinical study participant diversity to assess accuracy, particularly across different skin pigmentations, and mandates reporting and verification of clinical performance.
• Usability and Alarms: Includes usability guidelines, alarm system requirements, protection against electrical and mechanical hazards, as well as accuracy and electromagnetic compatibility specifications.
• Special Conditions of Use: Specific sections address performance under extreme or uncontrolled environmental conditions encountered in emergency medical services (EMS) and air transport.

Applications

ISO 80601-2-61:2026 serves as a vital reference for:

• Medical Device Manufacturers: Ensures pulse oximeters are compliant with the latest international safety and performance requirements, covering both newly produced and remanufactured equipment.
• Healthcare Providers: Supports procurement and safe operation of pulse oximeter equipment in hospitals, clinics, home healthcare, and emergency medical services.
• Regulatory Bodies: Assists in assessing conformity of pulse oximeter devices for market approval according to globally recognized standards, including the essential principles established by the International Medical Devices Regulators Forum (IMDRF) and requirements under EU Regulation 2017/745.
• Product Development and Testing: Guides the design, labeling, and verification of pulse oximeters, including the use of simulators, calibrators, and functional testers, to maintain accuracy and reliability.

Related Standards

ISO 80601-2-61:2026 is harmonized with and complements the following standards:

• IEC 60601-1: General standard for basic safety and essential performance of medical electrical equipment.
• IEC 60601-1-2: Electromagnetic compatibility requirements for ME equipment and ME systems.
• IEC 60601-1-6: Usability engineering of ME equipment.
• IEC 60601-1-8: Alarm systems in medical electrical equipment.
• IEC 60601-1-11: Requirements for ME equipment used in the home healthcare environment.
• IEC 60601-1-12: Requirements for ME equipment used in emergency medical services.
• ISO 20417: Information to be supplied by the manufacturer of medical devices.
• ISO 15223-1: Symbols to be used with medical device labels and information.
• ISO 14155: Clinical investigation of medical devices for human subjects – good clinical practice.

For a comprehensive approach to pulse oximeter development, testing, and use, manufacturers and healthcare organizations should ensure compliance with these standards alongside ISO 80601-2-61:2026. This reinforces patient safety, device accuracy, and regulatory acceptance across global markets.