EN ISO 11197:2019

Medical supply units (ISO 11197:2019)

Publication date:   Mar 16, 2020

General information

60.60 Standard published   Nov 27, 2019

CEN

CEN/TC 215 Respiratory and anaesthetic equipment

European Norm

11.040.10   Anaesthetic, respiratory and reanimation equipment

Buying

Published

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

Replaces
EN ISO 11197:2016

NOW

PUBLISHED
EN ISO 11197:2019
60.60 Standard published
Nov 27, 2019