Draft
International Standard
ISO/DIS 11197
Medical supply units
Reference number
ISO/DIS 11197
Edition 5
Proyecto Norma internacional
Preview
ISO/DIS 11197
85403
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Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Reemplazará ISO 11197:2019

ISO/DIS 11197

ISO/DIS 11197
85403
Idioma
Formato
CHF 63
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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

  •  : En desarrollo
    : Cierre de la votación [40.60]
  •  : 5
     : 42
  • ISO/TC 121/SC 6
    11.040.01 
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