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EN ISO 80601-2-55:2018 Standard

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  Keywords:

#intended #anaesthetic #rgm #monitoring #subclause

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)

  Purpose

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.

  Publication

Wednesday 14th of April 2021

  Related Standards

EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

EN ISO 23328-2:2009

Medical devices Directive (93/42/EEC)

Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)

EN 60601-2-3:1993

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipmentIEC 60601-2-3:1991

EN 60601-1-11:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: R...

EN 60601-1-1:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical el...

EN 60580:2000

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Dose area product metersIEC 60580:2000

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