IEC 60601-1-11:2015 RLV (Redline version)


Language: EN Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Language: FR Appareils électromédicaux – Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l’environnement des soins à domicile


Language: EN IEC 60601-1-11:2015 RLV contains both the official IEC International Standard and its Redline version. The Redline version is not an official document, it is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes: - the dwelling place in which a patient lives; - other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present. This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications: - correction of test method for relative humidity control at temperatures above 35 °C; - redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and - harmonizing with the changes to the amendments to the general standard and other collateral standards.

Language: EN
Date of issue
TC 62/SC 62A
ICS Codes
11.020.10, 11.040.01
Publication number

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€ 354,50 (Download and hardcopy)
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postal download (190 Pages)




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Mandatory Standard according current regulation Mandatory Standard according current regulation

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