Back

ISO 11197:2016

Medical supply units

General information
Withdrawn from 07.11.2019
Directives or regulations
None
Standard history
Status
Date
Type
Name
07.11.2019
Main
11.02.2016
Main
Main
ISO 11197:2004
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment. ISO 11197:2016 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 International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4). NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.
*
*
*
PDF
64.44 € incl tax
Paper
64.44 € incl tax
Standard monitoring