SRPS EN ISO 8835-4:2011

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

Scope

For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.
Addition:
ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.
ISO 8835-4:2004 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 ISO 8835-4:2004 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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.