Final Draft
International Standard
ISO/FDIS 11197
Medical supply units
Reference number
ISO/FDIS 11197
Edition 5
© ISO 2026
Proyecto final Norma internacional
En desarrollo
Este borrador está en fase de aprobación.
Reemplazará ISO 11197:2019

Resumen

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.

This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.

NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.

Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).

NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

Informaciones generales

  • Estado
     : En desarrollo
    Etapa
    : Texto final recibido o FDIS registrado para su aprobación formal [50.00]
  • Edición
     : 5
  • Comité Técnico :
    ISO/TC 121/SC 6
    ICS :
    11.040.01 
  • RSS actualizaciones

Ciclo de vida

Objetivos de Desarrollo Sostenible

Esta norma contribuye al siguiente Objetivo de Desarrollo Sostenible

3
Good Health and Well-being

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