ISO 11197:2019

Medical supply units

Publication date: Nov 7, 2019

General information

Current stage: 60.60 Effective date: Nov 7, 2019

Originator: ISO

Owner: ISO/TC 121/SC 6

Type: International Standard

ICS: 11.040.10

Languages: English French

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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

Revises
ISO 11197:2016

NOW

PUBLISHED
ISO 11197:2019
60.60 Standard published
Nov 7, 2019

REVISED BY

IN_DEVELOPMENT
ISO/PWI 11197

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