Reference number
ISO 11197:2019
© ISO 2025
International Standard
ISO 11197:2019
Medical supply units
Edition 4
2019-11
Read sample
Published (Edition 4, 2019)

ISO 11197:2019

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Format
CHF 177
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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.

General information

  • Status
     : Published
    Publication date
     : 2019-11
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 4
    Number of pages
     : 36
  • Technical Committee :
    ISO/TC 121/SC 6
    ICS :
    11.040.10 
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Next version under development

Draft
International Standard
ISO/DIS 11197
Medical supply units
Reference number
ISO/DIS 11197
Edition 1
© ISO 2025
Draft International Standard

ISO/DIS 11197

Medical supply units

ISO/DIS 11197

Language
Format
CHF 65
Convert Swiss francs (CHF) to your currency

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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