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ISO 11197:2019

Medical supply units

Nov 7, 2019

General information

90.92     May 19, 2023

ISO

ISO/TC 121/SC 6

International Standard

11.040.10  

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Published

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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

PREVIOUSLY

WITHDRAWN
ISO 11197:2016

NOW

PUBLISHED
ISO 11197:2019
90.92 Standard to be revised
May 19, 2023

REVISED BY

PROJECT
ISO/DIS 11197

National adoptions

SRPS EN ISO 11197:2020  
ISS

Medical supply units (ISO 11197:2019)

60.60   Standard published

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