EN ISO 8835-5:2004

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

WIs 107-110 are the result of the splitting of WI 092 - Revision, in parts of EN 740:1998 (CC/000724)
Extension of the DOW for WI 00215109 to DAV + 66 months - Res 440/2002 (NT/030117)
PARTIALLY supersedes EN 740:1998

Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-5:2004)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Aunahmen:
Dieser Teil von ISO 8835-5 legt besondere Anforderungen für die wesentliche Leistung von Anästhesie-Beatmungsgeräten (wie in 3.1 definiert) fest. In diesem Teil von ISO 8835 behandelte Anästhesie-Beatmungsgeräte sind immer ein Bestandteil eines Anästhesiesystems und dazu vorgesehen, ununterbrochen durch einen Anwender überwacht zu werden.
Dieser Teil von ISO 8835 gilt nicht für Anästhesie-Beatmungsgeräte, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, wie in Anhang BB festgelegt.
Es ist davon auszugehen, dass die Anforderungen von diesem Teil von ISO 8835, die die Anforderungen von IEC 60601-1:1988 und ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder verändern, Vorrang vor den entsprechenden allgemeinen Anforderungen haben.

Systèmes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-5:2004)

Inhalacijski anestezijski sistemi – 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-May-2004
• Withdrawal Date: 17-Mar-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 18-Mar-2009
• Completion Date: 18-Mar-2009
• 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 8835-5:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

Relations

• Replaced By: EN ISO 8835-5:2009 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 23-Mar-2009
• Corrected By: EN ISO 8835-5:2004/AC:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 08-Jun-2022
• Corrected By: EN ISO 8835-5:2004/AC:2006 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-5:2004
01-november-2004
1DGRPHãþD
SIST EN 740:2000
SIST EN 740:2000/AC:2000
Inhalacijski anestezijski sistemi – 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)
Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-
5:2004)
Systemes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-
5:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-5:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-5:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-5:2004



EUROPEAN STANDARD
EN ISO 8835-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2004
ICS 11.040.10 Supersedes EN 740:1998
English version
Inhalational anaesthesia systems - Part 5: Anaesthesia
ventilators (ISO 8835-5:2004)
Systèmes d'anesthésie par inhalation - Partie 5: Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-
Ventilateurs d'anesthésie (ISO 8835-5:2004) Beatmungsgeräte (ISO 8835-5:2004)
This European Standard was approved by CEN on 6 May 2004.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.




EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8835-5:2004: E
worldwide for CEN national Members.

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SIST EN ISO 8835-5:2004

EN ISO 8835-5:2004 (E)





Foreword


This document (EN ISO 8835-5:2004) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 November 2004, and conflicting national
standards shall be withdrawn at the latest by November 2009.

This document supersedes EN 740:1998.

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 EU
Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 8835-5:2004 has been approved by CEN as EN ISO 8835-5:2004 without any
modifications.

2

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EN ISO 8835-5:2004 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC

This European Standard has been prepared under a mandate given to CEN by the European

Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42 EEC.

Once this standard is cited in the Official Journal of the European Communities under that
Directive and has been implemented as a national standard in at least one Member State,
...