IEC 60601-2-75-ed.1.0

Detail information

Designation: IEC 60601-2-75-ed.1.0

Publication date: 30/05/2017

Pages: 59

Country: International technical standard

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Anotation

IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis 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 7.2.13 and 8.4.1 of the general standard. This document applies to photodynamic therapy and photodynamic diagnosis equipment used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an applied part for the target area), such equipment also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: - light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; - low-level laser therapy equipment not intended for use with a photosensitizer; - illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a photosensitizer. This document is to be used with IEC 60601-1:2005 and its amendment 1. L’IEC 60601-2-75 :2017 s’applique a la securite de base et aux performances essentielles des appareils de therapie photodynamique et de diagnostic photodynamique. Les dangers inherents a la fonction physiologique prevue de l’appareil EM ou des systemes EM relevant du domaine dapplication du present document ne sont pas couverts par les exigences specifiques du present document, a lexception de 7.2.13 et 8.4.1 de la norme generale. Le present document s’applique aux appareils de therapie photodynamique et de diagnostic photodynamique utilises pour traiter ou soulager une maladie, une blessure ou une incapacite. Dans le cas d’appareils combines (par exemple, appareils comportant une fonction ou une partie appliquee supplementaire pour la zone cible), les appareils concernes sont egalement conformes a toute norme particuliere qui specifie des exigences de securite pour la fonction supplementaire. La presente norme particuliere ne s’applique pas: - aux appareils de luminotherapie destines a etre utilises pour les ablations, coagulations et hyperthermies photothermiques; - aux appareils de therapie laser bas niveau non destines a etre utilises avec un photosensibilisant; - aux appareils d’eclairage destines a etre utilises a des fins d’observation, de surveillance et de diagnostic, non destines a etre utilises avec un photosensibilisant. Ce document est a utiliser avec l’IEC 60601-1 :2005 et son amendement 1.