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EN ISO 8835-5:2009 Standard

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  Keywords:

#part #requirements #anaesthetic #intended #applicable

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

  Purpose

This part of ISO 8835 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). This part of ISO 8835 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator. This part of ISO 8835 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB. 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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 8835-5:2004"

Anyway is still possible use the "EN ISO 8835-5:2004" until March 21st, 2010

  Related Standards

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EN 60627:2001

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EN 60601-2-54:2009

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EN 60601-2-52:2010/AC:2011

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