Sky Bear Technical Standards - Home
Search
×
FR

Placeholder headline

This is just a placeholder headline

B51-14 (R2019) – Boiler, pressure vessel, and pressure piping code

$

362

BUY NOW

IEC 80601-2-71:2025

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 (functional NIRS) equipment

CDN $646.00

This publication was last reviewed and confirmed in 2025.

Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment

SKU: 8c3d80fe33bb Categories: ,

Description

This document 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.
Edition

2

Published Date

2026-06-18

Status

PUBLISHED

Pages

117

Language Detail Icon

English

Format Secure Icon

Secure PDF

Abstract

This document 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.

Previous Editions

Can’t find what you are looking for?

Please contact us at: