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About This Item
Full Description
ISO 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988.
ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.
ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of ISO 21647:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.
Document History
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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- Most Recent
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ISO 80601-2-55:2011
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors- Historical Version
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ISO/DIS 80601-2-55
Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors- Historical Version
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ISO 21647/Cor1:2005
Corrigendum- Historical Version
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ISO 21647:2004
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Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors- Historical Version