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ISO 80601-2-55:2018

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

Pages: 66
Publication date: 2018-02-01
Price: 209 vnd

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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.
Document identifier
ISO 80601-2-55:2018
Title
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO Category
TC 121/SC 1: Breathing attachments and anaesthetic machines
Publication date
2018-02-01
Status
Effective
International Relationship
BS EN ISO 80601-2-55:2018 * DIN EN ISO 80601-2-55
Cross references
Latest version
ISO 80601-2-55:2018
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Document identifier ISO 80601-2-55:2018
Publication date 2018-02-01
Classification 11.040.10. Anaesthetic, respiratory and reanimation equipment
Status Effective
*
History of version
ISO 80601-2-55:2018 * ISO 80601-2-55:2011 * ISO 21647/Cor1:2005 * ISO 21647:2004
Keywords
Pages
66
Price 209 vnd