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IEC 60601-2-75-ed.1.1+Amd.1-CSV
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
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STANDARD published on 30.1.2023
The information about the standard:
Designation standards: IEC 60601-2-75-ed.1.1+Amd.1-CSV
Publication date standards: 30.1.2023
SKU: NS-1102279
The number of pages: 131
Approximate weight : 424 g (0.93 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-75-ed.1.1+Amd.1-CSV :
IEC 60601-2-75:2017+AMD1:2023 CSV 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+AMD1:2023 CSV 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.
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