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EN ISO 80601-2-61:2026

Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2026)

Edition date: 2026-04-22
In Force
Available languages: French, English
Summary: 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.

Le présent document s’applique à la sécurité de base et aux performances essentielles des oxymètres de pouls conçus pour une utilisation chez les êtres humains, ci-après dénommés appareils EM. Sont inclus tous les éléments de l’appareil nécessaires pour une utilisation normale, y compris le moniteur de l’oxymètre de pouls, le capteur de l’oxymètre de pouls et le câble de raccordement du capteur. Ces exigences s’appliquent aux oxymètres de pouls, y compris aux moniteurs de l'oxymètre de pouls, aux capteurs de l'oxymètre de pouls et aux câbles de raccordement du capteur, quelle que soit leur origine (c'est-à-dire y compris les produits remis à neuf). L’utilisation prévue des oxymètres de pouls inclut notamment, sans toutefois s’y limiter, l’estimation de la saturation en oxygène de l’hémoglobine artérielle et de la fréquence du pouls chez des patients en établissement de soins professionnel ainsi que chez les patients dans l’environnement des soins à domicile et dans l’environnement des services médicaux d’urgence. Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas. Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 201.11.1.2.2, l'IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 et 8.4.1. NOTE 2        Voir également l'IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. Le présent document peut également être appliqué aux appareils EM et à leurs accessoires utilisés pour l'atténuation d'une maladie, la compensation ou l'atténuation d'une blessure ou d'une incapacité. Le présent document ne s’applique pas aux oxymètres de pouls destinés à être utilisés dans le cadre de recherches en laboratoire, de même qu’aux oxymètres nécessitant un échantillon de sang du patient. Le présent document ne s’applique pas aux oxymètres de pouls destinés uniquement à la surveillance de fœtus. Le présent document ne s'applique pas aux appareils à distance ou asservis (secondaires) qui affichent les valeurs de SpO2 et qui sont situés en dehors de l'environnement du patient. NOTE 3        Il est attendu que les appareils EM qui offrent le choix entre des fonctions de diagnostic et de surveillance respectent les exigences appropriées du présent document lorsqu'ils sont configurés pour cette fonction. Le présent document est applicable aux oxymètres de pouls destinés à être utilisés dans des conditions environnementales extrêmes ou non maîtrisées à l’extérieur de l’environnement hospitalier ou d’un cabinet de médecin, telles que dans des ambulances ou dans les transports aériens. Des normes supplémentaires peuvent s’appliquer aux oxymètres de pouls pour ces environnements d’utilisation. Le présent document est une norme particulière de la série de normes IEC 60601-1 et ISO et IEC 80601.
ICS: 11.040.55-Diagnostic equipment
CTN: CEN/TC 215 - 6196

Otras Relaciones

Acuerdo de Viena ISO 80601-2-61:2026

Reemplazo Normas

Reemplaza a EN ISO 80601-2-61:2019

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