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EVS-EN ISO 11197:2019

Medical supply units (ISO 11197:2019)

General information
Valid from 16.12.2019
Base Documents
ISO 11197:2019; EN ISO 11197:2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.12.2019
Main
04.04.2016
Main
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.
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