Draft
International Standard
ISO/DIS 11197
Medical supply units
Reference number
ISO/DIS 11197
Edition 5
© ISO 2024
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 11197:2019

ISO/DIS 11197

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Format
CHF 63
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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
     : Under development
    Stage
    : Close of voting [40.60]
  • Edition
     : 5
    Number of pages
     : 42
  • Technical Committee :
    ISO/TC 121/SC 6
    ICS :
    11.040.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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