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Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
File Size: 397 kB
Language: English
Provider: ANSI
Shipping: Available for download - Link will be provided in My ComplianceOnline section
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.
Please find the corrigendum here.
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