ISO 80601-2-55:2018

International Standard   Current Edition · Approved on 12 February 2018

Medical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2018 Files

English 59 Pages
Current Edition
91.4 BHD

ISO 80601-2-55:2018 Scope

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.

Best Sellers

GSO 150-2:2013
 
Gulf Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
BH GSO 150-2:2015
GSO 150-2:2013 
Bahraini Standard
Expiration dates for food products - Part 2 : Voluntary expiration dates
BH GSO 2055-1:2016
GSO 2055-1:2015 
Bahraini Technical Regulation
HALAL FOOD - Part 1 : General Requirements
GSO 2055-1:2015
 
Gulf Technical Regulation
HALAL FOOD - Part 1 : General Requirements

Recently Published

ISO/TR 4752:2025
 
International Standard
Biotechnology — Inventory of methods for detection of microbiological contamination in mammalian cell culture
ISO 21043-3:2025
 
International Standard
Forensic sciences — Part 3: Analysis
ISO 19984-2:2025
 
International Standard
Rubber and rubber products — Determination of biobased content — Part 2: Biobased carbon content
ISO/TS 6417:2025
 
International Standard
Microfluidic pumps — Symbols and performance communication