IEC 80601-2-71-2025 PDF

Full title and description

IEC 80601-2-71:2025 — Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near‑infrared spectroscopy (NIRS) equipment. This part defines particular safety and essential‑performance requirements for functional NIRS devices used alone or as part of an ME system for producing functional NIRS output for adjunctive diagnostic and monitoring purposes.

Abstract

This second edition (2025) is a technical revision of IEC 80601-2-71 that updates and expands requirements for basic safety and essential performance of functional NIRS equipment. Key additions include explicit essential‑performance clauses, requirements for primary operating functions, protection against excessive temperatures, improved display legibility for operators wearing personal protective equipment, and harmonization where appropriate with ISO 20417 and related collateral standards. The document also clarifies exclusions (for example, tissue oximeters, time‑domain/frequency‑domain fNIRS, and chromophore measurements outside oxy/deoxy‑haemoglobin).

General information

• Status: Current / Valid (published and in force as the 2025 edition).
• Publication date: 14 January 2025 (official IEC publication date).
• Publisher: International Electrotechnical Commission (IEC), technical committee TC 62 / SC 62D (Particular medical equipment, software and systems).
• ICS / categories: 11.040.55 (Diagnostic equipment).
• Edition / version: Edition 2.0 (2025).
• Number of pages: 117 pages (IEC webstore listing for the official publication; national adoptions/EN versions sometimes list different pagination).

Scope

This standard applies to the basic safety and essential performance of functional near‑infrared spectroscopy (NIRS) equipment as defined in the standard (functional NIRS intended to measure changes in oxy‑ and deoxy‑haemoglobin concentration in the brain). It is intended for NIRS equipment used alone or as part of an ME system and addresses hazards covered by IEC 60601‑1 and its amendments. The standard excludes tissue oximeters (see ISO 80601‑2‑85), frequency‑domain/time‑domain fNIRS systems, measurement of chromophores other than oxy‑ and deoxy‑haemoglobin, and measurement in tissues other than the brain.

Key topics and requirements

• Requirements for basic safety and explicit essential‑performance criteria for functional NIRS equipment.
• Primary operating function definitions and tests to demonstrate continued essential performance under fault or foreseeable misuse conditions.
• Thermal protection and requirements to limit excessive temperatures of parts that contact the patient or operator.
• Display legibility requirements for operators wearing personal protective equipment (PPE) and human‑machine interface considerations.
• Electromagnetic compatibility and alignment with IEC 60601‑1‑2 and other relevant collateral standards.
• Harmonization with labeling and information requirements (e.g., ISO 20417) and references to related pulse oximetry and cerebral oximetry standards where applicable.
• Clear statement of exclusions (e.g., tissue oximeters and certain measurement modalities) and normative references to ISO 80601‑2‑85 and ISO 80601‑2‑61 for related device classes.

Typical use and users

Intended users include medical device manufacturers (design and compliance teams), clinical engineers, regulatory affairs professionals, hospital procurement and safety officers, and clinical researchers using or developing functional NIRS systems for brain monitoring and neuroimaging applications. The standard is used during design, risk assessment, verification/validation, and regulatory submissions for NIRS equipment.

Related standards

Key related standards and collateral documents include IEC 60601‑1 (general requirements for basic safety and essential performance), IEC 60601‑1‑2 (EMC), IEC 60601‑1‑6 (usability), ISO 80601‑2‑85 (cerebral tissue oximeter equipment), ISO 80601‑2‑61 (pulse oximeter equipment), and ISO 20417 (information to be supplied by the manufacturer). National/adopted EN versions of IEC 80601‑2‑71:2025 exist for European markets.

Keywords

functional NIRS, near‑infrared spectroscopy, NIRS equipment, medical electrical equipment, IEC 80601, essential performance, basic safety, thermal protection, display legibility, TC 62/SC 62D.

FAQ

Q: What is this standard?

A: IEC 80601‑2‑71:2025 is the part‑2 particular standard in the IEC 80601 series that sets out particular requirements for the basic safety and essential performance of functional near‑infrared spectroscopy (NIRS) equipment.

Q: What does it cover?

A: It covers safety and essential‑performance requirements, tests, and documentation specific to functional NIRS devices used for measuring changes in oxy‑ and deoxy‑haemoglobin in the brain, including new provisions for essential performance, primary operating functions, thermal protection, and display legibility for operators wearing PPE. It explicitly excludes certain device types (e.g., tissue oximeters and some modality classes).

Q: Who typically uses it?

A: Medical device manufacturers, test laboratories, regulatory and compliance teams, clinical engineers, and researchers developing or evaluating functional NIRS systems. It is also referenced by standards bodies and conformity‑assessment organizations during product certification and national adoption.

Q: Is it current or superseded?

A: Current. IEC 80601‑2‑71:2025 is the second edition published in 2025 and cancels and replaces the first edition from 2015.

Q: Is it part of a series?

A: Yes — it is a Part 2‑71 particular standard within the IEC 80601 family (medical electrical equipment) and interacts with IEC 60601‑1 and its collateral and particular standards as well as related ISO 80601‑2 series standards.

Q: What are the key keywords?

A: Functional NIRS, near‑infrared spectroscopy, NIRS equipment, basic safety, essential performance, IEC 80601, thermal protection, display legibility, primary operating functions.