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ISO 21647:2004Withdrawn

Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors

Appareils électromédicaux — Prescriptions particulières relatives à la sécurité et aux performances de base des moniteurs de gaz respiratoires

Abstract / scope

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.

Life cycle

Amendments & corrigenda

ISO 21647:2004/Cor 1:2005WithdrawnMedical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors — Technical Corrigendum 1International Standard · Published 13 Jul 2005 · ISO/TC 121/SC 1

Replaces

ISO 9918:1993WithdrawnCapnometers for use with humans — RequirementsInternational Standard · Published 18 Feb 1993 · ISO/TC 121/SC 1ISO 11196:1995WithdrawnAnaesthetic gas monitorsInternational Standard · Published 28 Sep 1995 · ISO/TC 121/SC 1ISO 11196:1995/Cor 1:1997WithdrawnAnaesthetic gas monitors — Technical Corrigendum 1International Standard · Published 13 Feb 1997 · ISO/TC 121/SC 1ISO 7767:1997WithdrawnOxygen monitors for monitoring patient breathing mixtures — Safety requirementsInternational Standard · Published 24 Apr 1997 · ISO/TC 121/SC 1

Replaced by

ISO/WD 21647Deleted (project abandoned)Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitorsInternational Standard · ISO/TC 121/SC 1ISO 80601-2-55:2011WithdrawnMedical electrical equipment — Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsInternational Standard · Published 15 Dec 2011 · ISO/TC 121/SC 1