NF EN ISO 80601-2-55

NF EN ISO 80601-2-55

February 2012
Standard Cancelled

Medical electrical equipment - Part 2-55 : particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.ISO 80601-2-55:2011 specifies requirements for: anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.

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Main informations

Collections

National standards and national normative documents

Publication date

February 2012

Number of pages

71 p.

Reference

NF EN ISO 80601-2-55

ICS Codes

11.040.10   Anaesthetic, respiratory and reanimation equipment

Classification index

S95-190

Print number

1 - 10/02/2012

International kinship

ISO 80601-2-55:2011

European kinship

EN ISO 80601-2-55:2011
Sumary
Medical electrical equipment - Part 2-55 : particular requirements for the basic safety and essential performance of respiratory gas monitors

ISO 80601-2-55:2011 specifies particular requirements for the basic safety and essential performance of a respiratory gas monitor (RGM) intended for continuous operation for use with a patient.

ISO 80601-2-55:2011 specifies requirements for:

  • anaesthetic gas monitoring,
  • carbon dioxide monitoring, and
  • oxygen monitoring.

ISO 80601-2-55:2011 is not applicable to an RGM intended for use with flammable anaesthetic agents.

Replaced standards (1)
NF EN ISO 21647
August 2009
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.

Standard replaced by (1)
NF EN ISO 22476-2
July 2005
Standard Current
Geotechnical investigation and testing - Field testing - Part 2 : dynamic probing

ISO 22476-2:2005 specifies requirements for indirect investigations of soil by dynamic probing within the scope of the geotechnical investigations according to prEN 1997.

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