Oxygen monitors for patient breathing mixtures - Particular requirements

Le présent document fixe les spécifications des moniteurs d'oxygène avec ou sans aspiration. Il se lit conjointement avec la norme NF EN 60601 -1 portant sur la sécurité des appareils électromédicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

March 2000

Number of pages

36 p.

Reference

NF EN 12598

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-144

Print number

1 - 13/05/2004

European kinship

EN 12598:1999

Sumary

Oxygen monitors for patient breathing mixtures - Particular requirements

Le présent document fixe les spécifications des moniteurs d'oxygène avec ou sans aspiration. Il se lit conjointement avec la norme NF EN 60601 -1 portant sur la sécurité des appareils électromédicaux.

Replaced standards (1)

NF ISO 7767

June 1989

Standard Cancelled

Oxygen analysers for monitoring patient breathing mixtures.

La présente norme fixe les spécifications liées à la sécurité dont la sécurité électrique et les caractéristiques liées à la mesure du niveau d'oxygène en tenant compte des interférences potentielles.

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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