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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

Medical devices Directive (93/42/EEC)

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

EN 12470-4:2000+A1:2009

Medical devices Directive (93/42/EEC)

Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement

EN ISO 7376:2009

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Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

EN ISO 5840:2009

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Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

EN ISO 5366-1:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)

EN ISO 5360:2009

Medical devices Directive (93/42/EEC)

Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

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