Medical electrical equipment. Capnometers for use with humans. Particular requirements.

Le présent document s'applique aux capnomètres à cellules incluses ainsi qu'aux appareils par aspiration. Ce document donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1 sur les appareils électromédicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

January 1997

Number of pages

40 p.

Reference

NF EN 864

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

11.040.55 Diagnostic equipment

Classification index

S95-156

Print number

1 - 01/01/1997

European kinship

EN 864:1996

Sumary

Medical electrical equipment. Capnometers for use with humans. Particular requirements.

Le présent document s'applique aux capnomètres à cellules incluses ainsi qu'aux appareils par aspiration. Ce document donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1 sur les appareils électromédicaux.

Standard replaced by (1)

NF EN ISO 21647

April 2006

Standard Cancelled

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

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.

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