ISO 80601-2-55:2018 

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

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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.

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Additional information

Publication typeInternational Standard
Publication date2018-02-12
Edition2.0
Available language(s)English, French
TC/SCTC 62/SC 62D - Electromedical equipmentrss
ICS11.040.10 - Anaesthetic, respiratory and reanimation equipment
Stability date  2019
Pages59
File size1715 KB

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