This part of ISO 8835 specifies requirements for anaesthetic breathing systems that are supplied either
assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's
instructions.
It also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some
designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic
system, including the expiratory gas pathway of an anaesthetic ventilator.
This part of ISO 8835 does not cover the performance of anaesthetic breathing systems regarding the
elimination of expired carbon dioxide since this is complex and depends on the interaction of the patient, the
fresh gas flow, the carbon dioxide absorbent and the anaesthetic breathing system itself.
This part of ISO 8835 does not apply to anaesthetic breathing systems intended for use with flammable
anaesthetic agents/gases as determined by Annex DD of IEC 60601-2-13:2003.
DIN EN ISO 8835-2:2007 history
2013DIN EN ISO 80601-2-13:2013 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011); German version EN ISO 80601-2-13:2012
2007DIN EN 60601-2-13:2007 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003 + A1:2006); German version EN 60601-2-13:2006 + A1:2007
1999DIN EN 740:1999 Anaesthetic workstations and their modules - Particular requirements (including corrigendum AC:1998); German version EN 740:1998 + AC:1998