BS EN ISO 80601-2-61:2026

This standard BS EN ISO 80601-2-61:2026 Medical electrical equipment is classified in these ICS categories:

• 11.040.10 Anaesthetic, respiratory and reanimation equipment
• 11.040.55 Diagnostic equipment

This document applies to the basic safety and essential performance of pulse oximeter equipment intended for use on humans, hereafter referred to as ME equipment. This includes any part necessary for normal use, including the pulse oximeter monitor, pulse oximeter probe, and probe cable extender. These requirements apply to pulse oximeter equipment, including pulse oximeter monitors, pulse oximeter probes and probe cable extenders regardless of their origin (i.e. including remanufactured products). The intended use of pulse oximeter equipment includes, but is not limited to, the estimation of arterial oxygen haemoglobin saturation and pulse rate of patients in professional healthcare institutions as well as patients in the home healthcare environment and the emergency medical services environment. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause says so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 201.11.1.2.2, IEC 60601-1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 2        See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2. This document can also be applied to ME equipment and their accessories used for compensation or alleviation of disease, injury, or disability. This document is not applicable to pulse oximeter equipment intended for use in laboratory research applications nor to oximeters that require a blood sample from the patient. This document is not applicable to pulse oximeter equipment intended solely for foetal use. This document is not applicable to remote or slave (secondary) equipment that displays SpO2 values that are located outside of the patient environment. NOTE 3        ME equipment that provides selection between diagnostic and monitoring functions is expected to meet the appropriate requirements of this document when configured for that function. This document is applicable to pulse oximeter equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, such as in ambulances and air transport. Additional standards can apply to pulse oximeter equipment for those environments of use. This document is a particular standard in the IEC 60601-1 and ISO and IEC 80601 series of standards.

BS EN ISO 80601-2-61:2026 - Medical Electrical Equipment Standard

Introducing the BS EN ISO 80601-2-61:2026, a comprehensive standard that sets the benchmark for the basic safety and essential performance of pulse oximeter equipment. This standard is an indispensable resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of medical electrical equipment.

Overview

The BS EN ISO 80601-2-61:2026 standard is meticulously crafted to ensure that pulse oximeter equipment meets the highest safety and performance criteria. Released on June 9, 2026, this standard is the latest in a series of updates that reflect the evolving technological advancements and regulatory requirements in the medical field.

Key Features

• Standard Number: BS EN ISO 80601-2-61:2026
• Pages: 164
• ISBN: 978 0 539 21239 6
• Status: Standard

Why This Standard is Essential

Pulse oximeters are critical devices used in various medical settings to monitor a patient's oxygen saturation and pulse rate. Ensuring their reliability and safety is paramount, as these devices play a crucial role in patient care. The BS EN ISO 80601-2-61:2026 standard provides detailed guidelines that help manufacturers design equipment that is not only effective but also safe for use in diverse healthcare environments.

Comprehensive Safety Guidelines

This standard outlines specific safety requirements that pulse oximeters must meet to prevent electrical hazards, mechanical failures, and other risks that could compromise patient safety. By adhering to these guidelines, manufacturers can ensure that their products are robust and reliable.

Performance Criteria

In addition to safety, the standard emphasizes the importance of performance. It provides criteria for the accuracy and reliability of pulse oximeter readings, ensuring that healthcare providers can trust the data these devices provide. This is crucial for making informed clinical decisions and delivering high-quality patient care.

Who Should Use This Standard?

The BS EN ISO 80601-2-61:2026 standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: To ensure their products meet international safety and performance standards.
• Regulatory Bodies: To evaluate and approve pulse oximeter equipment for market entry.
• Healthcare Providers: To understand the safety and performance benchmarks of the equipment they use.

Benefits of Compliance

Compliance with the BS EN ISO 80601-2-61:2026 standard offers numerous benefits, including:

• Enhanced Safety: Reducing the risk of device-related incidents and ensuring patient safety.
• Improved Performance: Ensuring accurate and reliable readings, which are critical for patient monitoring.
• Market Access: Facilitating entry into global markets by meeting international standards.
• Reputation: Building trust with healthcare providers and patients by demonstrating a commitment to quality and safety.

Conclusion

The BS EN ISO 80601-2-61:2026 standard is an essential tool for anyone involved in the design, production, or use of pulse oximeter equipment. By providing clear guidelines for safety and performance, it helps ensure that these critical devices are reliable and effective in delivering high-quality patient care. Whether you are a manufacturer, a regulatory body, or a healthcare provider, this standard is a valuable resource that supports the development and use of safe and effective medical electrical equipment.