Skip to main content
Back

EVS-EN ISO 8835-4:2009

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices

General information

Withdrawn from 04.01.2013
Base Documents
ISO 8835-4:2004; EN ISO 8835-4:2009
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
04.01.2013
Main
Main
EVS-EN ISO 8835-4:2004
This part of ISO 8835 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. This part of ISO 8835 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. This part of ISO 8835 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.  This part of ISO 8835 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers). The requirements of this part of ISO 8835 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.

Required fields are indicated with *

*
*
*
PDF
19.52 € incl tax
Paper
19.52 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring