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SRPS EN ISO 11197:2020

Medical supply units (ISO 11197:2019)

May 29, 2020

General information

60.60     May 12, 2020

ISS

Z076

European Norm

11.040.10  

English  

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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

NOW

PUBLISHED
SRPS EN ISO 11197:2020
60.60 Standard published
May 12, 2020

REVISED BY

PROJECT
naSRPS EN ISO 11197:2023

Related project

Adopted from EN ISO 11197:2019

Adopted from ISO 11197:2019