Reference number
ISO 80601-2-55:2018
© ISO 2024
International Standard
ISO 80601-2-55:2018
Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Edition 2
2018-02
Read sample
Published (Edition 2, 2018)
This publication was last reviewed and confirmed in 2024. Therefore this version remains current.
This standard has 1 amendment.

ISO 80601-2-55:2018

Language
Format
CHF 194
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Abstract

ISO 80601-2-55:2018 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (rgm), hereafter referred to as me equipment, intended for continuous operation for use with a patient.

ISO 80601-2-55:2018 specifies requirements for

- anaesthetic gas monitoring,

- carbon dioxide monitoring, and

- oxygen monitoring.

NOTE 1 An rgm can be either stand-alone me equipment or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.

ISO 80601-2-55:2018 is not applicable to an rgm intended for use with flammable anaesthetic agents.

If a clause or subclause is specifically intended to be applicable to me equipment only or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+Amd 1:2012, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601‑1:2005+Amd 1:2012, 4.2.

General information

  • Status
     : Published
    Publication date
     : 2018-02
    Stage
    : International Standard confirmed [90.93]
  • Edition
     : 2
    Number of pages
     : 59
  • Technical Committee :
    ISO/TC 121/SC 1
    ICS :
    11.040.10 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Edition 2023

Language
Format
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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