SIST EN ISO 80601-2-61:2026

Overview

SIST EN ISO 80601-2-61:2026 specifies the particular requirements for basic safety and essential performance of pulse oximeter equipment intended for human use. This standard covers all essential components necessary for routine operation, including the pulse oximeter monitor, probe, and probe cable extender. It applies to equipment used across various healthcare settings such as hospitals, home healthcare environments, and emergency medical services, including situations outside traditional clinical settings like ambulances and air transport.

Pulse oximetry is a critical non-invasive technique for estimating arterial oxygen haemoglobin saturation and pulse rate, providing valuable real-time data for patient monitoring and clinical decision-making. This standard ensures that pulse oximeter devices meet international safety and performance expectations, helping manufacturers, healthcare providers, and regulators align with state-of-the-art requirements.

Key Topics

• Scope of Application: The standard applies to all pulse oximeter equipment and necessary accessories intended for human use, including remanufactured and refurbished products.
• Exclusions: This document does not cover pulse oximeter equipment intended for laboratory research, oximeters requiring a blood sample, foetal use, or remote/slave display equipment outside the patient environment.
• Safety and Performance: Focused on minimizing hazards and ensuring reliable performance in a broad range of environmental and clinical conditions.
• Environmental Suitability: Addresses basic safety in diverse environments-including professional healthcare facilities, home, and emergency services-by referencing additional applicable standards for extreme or uncontrolled environments.
• Accessories: Highlights that accessories, such as probes and cable extenders, must meet the same stringent safety and performance requirements as the main monitor unit.
• Diversity and Inclusion in Testing: Requires participant diversity in clinical studies to ensure accuracy across different skin pigmentations and patient demographics.
• Conformity Assessment: Refers to international guidelines (such as those from IMDRF and the European regulation EU 2017/745) for essential performance and labelling.

Applications

Pulse oximeter equipment standardized under SIST EN ISO 80601-2-61:2026 is vital for:

• Acute Clinical Monitoring: Used in operating rooms, intensive care units, and emergency departments to continually assess a patient’s oxygenation and pulse rate.
• Home Healthcare: Enabling patient monitoring by clinicians or trained caregivers outside the hospital, especially useful for chronic respiratory conditions.
• Emergency Medical Services: Ensures reliable operation in ambulances, during air transport, and at the scene in pre-hospital settings.
• Disease, Injury, or Disability Compensation: Applicable for monitoring and supporting patients requiring oxygen saturation surveillance due to various health impairments.
• Safe Integration: Facilitates the safe combination of different system components, ensuring all parts, including accessories, work together without compromising patient safety.

The standard helps manufacturers ensure their products are compliant with international best practices and regulatory requirements, supporting market access and user confidence.

Related Standards

For a comprehensive approach to the safety and performance of medical electrical equipment, refer to the related standards:

• IEC 60601-1 (General Requirements): Foundational standard for medical electrical equipment safety.
• IEC 60601-1-2 (Electromagnetic Compatibility): Ensures oximeters operate reliably in various electromagnetic environments.
• IEC 60601-1-11: Requirements for home healthcare environments.
• IEC 60601-1-12: Requirements for emergency medical service environments.
• ISO 20417: General information provided by manufacturers for medical devices.
• ISO 14155: Good clinical practice for medical device clinical investigations.
• ISO 15223-1: Symbols for medical device labels and labelling.

By adhering to SIST EN ISO 80601-2-61:2026 and its related standards, healthcare stakeholders ensure the safe, effective, and reliable use of pulse oximeters across diverse clinical applications.