Inhalational anaesthesia systems - Anaesthetic vapour delivery devices
Inhalational anaesthesia systems - Anaesthetic vapour delivery devices
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BS EN ISO 8835-4:2009 Inhalational anaesthesia systems. Anaesthetic vapour delivery devices BS EN ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
Part 2: Anaesthetic breathing systems for adults Part 3: Anaesthetic gas scavenging systems. Transfer and receiving systems Part 4: Anaesthetic vapour delivery devices Part 5: Anaesthetic ventilators
BS EN ISO 8835-4 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs). This international standard is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. Part 4 of BS EN ISO 8835 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13 . BS EN ISO 8835-4 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. Contents of BS EN ISO 8835-4 include:
Scope Normative references Terms and definitions General requirements and general requirements for tests Classification Identification, marking and documents Power input Basic safety categories Removable protective means Environmental conditions Requirements related to classification Limitation of volt...
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