ISO 21647:2004

$50.70

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

Published By	Publication Date	Number of Pages
ISO	2004-11	50

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, ISO

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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.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2004-11
Pages Count	50
Language	English
Edition	1
File Size	358.4 KB
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment

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ISO 21647:2004

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