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ISO 11197:2016

Medical supply units

Feb 11, 2016
95.99   Withdrawal of Standard   Nov 7, 2019

General information

95.99     Nov 7, 2019

ISO

ISO/TC 121/SC 6

International Standard

11.040.10  

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Scope

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.
ISO 11197:2016 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 International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1:2005+A1:2012 (see 201.1.4).
NOTE 2 See also IEC 60601-1:2005+A1:2012, 4.2.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 11197:2004

NOW

WITHDRAWN
ISO 11197:2016
95.99 Withdrawal of Standard
Nov 7, 2019

REVISED BY

PUBLISHED
ISO 11197:2019

National adoptions

SRPS EN ISO 11197:2017  
ISS

Medical supply units (ISO 11197:2016)

60.60   Standard published

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