BS EN IEC 80601-2-71:2025 - Medical Electrical Equipment Standard

Introducing the BS EN IEC 80601-2-71:2025, a comprehensive standard that sets the benchmark for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment. This standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of medical electrical equipment.

Overview

The BS EN IEC 80601-2-71:2025 standard is meticulously crafted to ensure that NIRS equipment meets the highest safety and performance criteria. Released on March 17, 2025, this standard is a critical update in the field of medical electrical equipment, reflecting the latest technological advancements and safety protocols.

Key Features

• Standard Number: BS EN IEC 80601-2-71:2025
• Pages: 62
• ISBN: 978 0 539 16765 8
• Status: Standard

Why Choose This Standard?

The BS EN IEC 80601-2-71:2025 standard is indispensable for ensuring that NIRS equipment is safe and effective for clinical use. It provides detailed guidelines on the design and testing of equipment, ensuring that it meets rigorous safety and performance standards. This is crucial for protecting patients and healthcare providers from potential risks associated with the use of medical electrical equipment.

Comprehensive Safety Guidelines

This standard outlines specific requirements for the basic safety of NIRS equipment, addressing potential hazards and providing solutions to mitigate risks. It covers aspects such as electrical safety, mechanical safety, and protection against radiation, ensuring that the equipment is safe for both patients and operators.

Essential Performance Criteria

Performance is a critical aspect of medical equipment, and the BS EN IEC 80601-2-71:2025 standard provides detailed criteria to ensure that NIRS equipment performs reliably and accurately. This includes guidelines on the accuracy of measurements, response times, and the overall functionality of the equipment under various conditions.

Who Should Use This Standard?

This standard is essential for a wide range of stakeholders in the medical field, including:

• Manufacturers: To ensure that their products meet international safety and performance standards.
• Healthcare Providers: To select equipment that is safe and effective for patient care.
• Regulatory Bodies: To assess and approve medical equipment for clinical use.
• Researchers: To develop new technologies and improve existing equipment.

Benefits of Compliance

Compliance with the BS EN IEC 80601-2-71:2025 standard offers numerous benefits, including:

• Enhanced Safety: Reducing the risk of harm to patients and healthcare providers.
• Improved Performance: Ensuring accurate and reliable measurements.
• Regulatory Approval: Facilitating the approval process for new equipment.
• Market Access: Meeting international standards to access global markets.

Conclusion

The BS EN IEC 80601-2-71:2025 standard is a vital resource for anyone involved in the development, production, or use of functional near-infrared spectroscopy equipment. By adhering to this standard, stakeholders can ensure that their equipment is safe, effective, and compliant with the latest international guidelines. This not only protects patients and healthcare providers but also enhances the credibility and marketability of the equipment.

Invest in the BS EN IEC 80601-2-71:2025 standard today to ensure that your NIRS equipment meets the highest standards of safety and performance.

BS EN IEC 80601-2-71:2025

This standard BS EN IEC 80601-2-71:2025 Medical electrical equipment is classified in these ICS categories:

• 11.040.55 Diagnostic equipment

IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME EQUIPMENT. 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1. This document is not applicable to – equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters; – frequency-domain and time-domain equipment for functional near-infrared spectroscopy; – equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin; – equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues other than the brain. This document does not specify the requirements for: – cerebral tissue oximeter equipment, which are given in ISO 80601-2-85; and – pulse oximeter equipment, which are given in ISO 80601-2-61. IEC 80601-2-71:2025 cancels and replaces the first edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020; b) added requirements for ESSENTIAL PERFORMANCE; c) added requirements for PRIMARY OPERATING FUNCTIONS; d) added requirements for protection against excessive temperatures; e) added requirements for the display legibility for OPERATORS wearing personal protective equipment; f) harmonization with ISO 20417, where appropriate.