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EVS-EN ISO 8835-5:2009

Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators

General information

Withdrawn from 04.01.2013
Base Documents
ISO 8835-5:2004; EN ISO 8835-5:2009
ICS Groups
11.040.10 Anaesthetic, respiratory and reanimation equipment
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Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard.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
EVS-EN ISO 80601-2-13:2012
Main
EVS-EN ISO 8835-5:2009
Main
EVS-EN ISO 8835-5:2004
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.

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Standard monitoring
English (PDF 395 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English