Standard

ISO 11197:2019

Nov 2019 Current

Note: Now under development: ISO/DIS 11197

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Abstract

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.

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Standard from ISO
Published: November 7 2019
Edition: 4
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.040.10
International TC: ISO/TC 121/SC 6

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Adopted by: SN EN ISO 11197:2020
Adopted by: NF EN ISO 11197:2019
Revises: ISO 11197:2016
Revised by: ISO/DIS 11197

ISO 11197:2019

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ISO 11197:2019

ISO 11197:2016

ISO 11197:2004

ISO 11197:1996

Abstract

Products specifications

Product Relations

Product life cycle

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Version history History (4)

ISO 11197:2019

ISO 11197:2016

ISO 11197:2004

ISO 11197:1996

Abstract

Products specifications

Product Relations

Product life cycle