NF EN ISO 11196

November 1997

Standard Cancelled

Aneasthetic gas monitors.

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Main informations

Collections

National standards and national normative documents

Publication date

November 1997

Number of pages

48 p.

Reference

NF EN ISO 11196

ICS Codes

11.040.10 Anaesthetic, respiratory and reanimation equipment

Classification index

S95-148

Print number

1 - 01/10/1997

International kinship

ISO 11196:1995

European kinship

EN ISO 11196:1997

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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