EN ISO 8835-2:2009

Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

ISO 8835-2:2007 specifies requirements for anaesthetic breathing systems that are supplied either assembled by the manufacturer or for assembly by the user in accordance with the manufacturer's instructions.
ISO 8835-2:2007 also covers circle absorber assemblies, exhaust valves, inspiratory and expiratory valves and, in some designs, those parts of an anaesthetic breathing system that are incorporated within an inhalation anaesthetic system, including the expiratory gas pathway of an anaesthetic ventilator.

Systeme für die Inhalationsanästhesie - Teil 2: Anästhesie-Atemsysteme (ISO 8835-2:2007)

Dieser Teil von ISO 8835 legt Anforderungen für Anästhesie-Atemsysteme fest, die entweder vom Hersteller
montiert geliefert werden oder vom Betreiber nach den Herstelleranweisungen zusammen gebaut werden.
Er behandelt auch Absorber-Baugruppen für ein Kreissystem, Abgasventile, Ein- und Ausatemventile und für
einige Konstruktionen diejenigen Teile eines Anästhesie-Atemsystems, die in ein Inhalations-Anästhesiesystem
eingebaut sind, einschließlich des Weges eines Anästhesie-Beatmungsgeräts für ausgeatmetes Gas.
Dieser Teil von ISO 8835 behandelt nicht die Leistung von Anästhesie-Atemsystemen hinsichtlich der
Beseitigung ausgeatmeten Kohlenstoffdioxids, da dies ein komplexer Vorgang ist und von der Wechselwirkung
mit dem Patienten, dem Frischgasstrom, dem Absorptionsmittel für das Kohlenstoffdioxid und vom
Anästhesie-Atemsystem selbst abhängt.
Dieser Teil von ISO 8835 gilt nicht für Anästhesie-Atemsysteme, die für die Verwendung mit brennbaren
Anästhesiemitteln bzw. -gasen bestimmt nach IEC 60601-2-13:2003, Anhang DD vorgesehen sind.

Systèmes d'anesthésie par inhalation - Partie 2: Systèmes respiratoires d'anesthésie (ISO 8835-2:2007)

L'ISO 8835-2:2007 spécifie les exigences relatives aux systèmes respiratoires d'anesthésie fournis prémontés ou à monter par l'utilisateur, conformément aux instructions du fabricant.
L'ISO 8835-2:2007 traite également des montages circulaires avec absorbeur, des valves d'évacuation, ainsi que des valves inspiratoires et expiratoires et, pour les modèles pertinents de systèmes respiratoires d'anesthésie par inhalation, des pièces faisant partie intégrante des systèmes d'anesthésie, y compris les systèmes d'évacuation des gaz des ventilateurs d'anesthésie.

Inhalacijski anestezijski sistemi - 2. del: Anestezijski dihalni sistemi (ISO 8835-2:2007)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 11-Dec-2012
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 12-Dec-2012
• Completion Date: 12-Dec-2012
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 8835-2:2009 - Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

Relations

• Replaces: EN ISO 8835-2:2007 - Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 80601-2-13:2012 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
• Effective Date: 26-Dec-2012

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 8835-2:2008
Inhalacijski anestezijski sistemi - 2. del: Anestezijski dihalni sistemi (ISO 8835-
2:2007)
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-
2:2007)
Systeme für die Inhalationsanästhesie - Teil 2: Anästhesie-Atemsysteme (ISO 8835-
2:2007)
Systèmes d'anesthésie par inhalation - Partie 2: Systèmes respiratoires d'anesthésie
(ISO 8835-2:2007)
Ta slovenski standard je istoveten z: EN ISO 8835-2:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-2:2009

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SIST EN ISO 8835-2:2009
EUROPEAN STANDARD
EN ISO 8835-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 8835-2:2007
English Version
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing
systems (ISO 8835-2:2007)
Systèmes d'anesthésie par inhalation - Partie 2: Systèmes Systeme für die Inhalationsanästhesie - Teil 2: Anästhesie-
respiratoires d'anesthésie (ISO 8835-2:2007) Atemsysteme (ISO 8835-2:2007)
This European Standard was approved by CEN on 14 March 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8835-2:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8835-2:2009
EN ISO 8835-2:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC .4

2

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SIST EN ISO 8835-2:2009
EN ISO 8835-2:2009 (E)
Foreword
The text of ISO 8835-2:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 8835-2:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8835-2:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
Other European Standards relating to anaesthetic workstations and their components prepared by CEN/TC
215 which together with EN 60601-2-13:2006, replace appropriate  portions of EN 740:1998, are:
– EN ISO 8835-2:2007, Inhalational anaesthesia systems – Part 2: Anaesthetic breathing systems (ISO 8835-
2:2007)
– EN ISO 8835-3:2007, Inhalational anaesthesia systems – Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems (ISO 8835-3:2007)
– EN
...