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

SS-EN-ISO-8835-4 - 2009 EDITION - SUPERSEDED
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IEC 60601-1:1988, Clause 1 applies except as follows. Addition: 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.

To find similar documents by classification:

11.040.10 (Anaesthetic, respiratory and reanimation equipment Including medical gas installations)


Medical devices. Revised Machinery Directive
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Designation Name

SS-EN ISO 8835-4:2009

Revision Level

2009 EDITION

Status

Superseded

Publication Date

April 20, 2009

Language(s)

English

Page Count

40

International Equivalent

EN ISO 8835-4:2009(IDT); ISO 8835-4:2004(IDT)