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EN ISO 8835-3:2009

(Main)

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

ISO 8835-3:2007 specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems (active AGSSs) intended to reduce exposure of healthcare personnel to anaesthetic gases and vapours while providing patient protection (e.g. against excessive flow and pressure).
ISO 8835-3:2007 also specifies requirements for transfer and receiving systems of active anaesthetic gas scavenging systems in which the power device is integral with the transfer and receiving system.

Systeme für die Inhalationsanästhesie - Teil 3: Weiterleitungs- und Aufnahmesysteme von aktiven Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007)

Dieser Teil von ISO 8835 legt Anforderungen für Weiterleitungs  und Aufnahmesysteme von aktiven Anästhesiegas-Fortleitungssystemen (aktive AGFS) fest, deren Ziel es ist, die Exposition des medizinischen Personals gegenüber Anästhesiegasen und  dämpfen zu verringern und gleichzeitig den Patienten zu schützen (z. B. gegen übermäßigen Gasdurchfluss und Druck). Dieser Teil von ISO 8835 legt auch Anforderungen für Weiterleitungs- und Aufnahmesysteme von aktiven Anästhesiegas-Fortleitungssystemen fest, in denen die Antriebseinrichtung in das Weiterleitungs  und Aufnahmesystem integriert ist.
Dieser Teil von ISO 8835 legt keine Anforderungen fest für
-   Entsorgungssysteme, die in ISO 7396-2 behandelt werden,
-   nichtaktive AGFS (passive AGFS),
-   in der Nähe untergebrachte Gasfortleitungssysteme (d. h. Systeme, die nicht direkt an das Atemsystem angeschlossen sind, oder zugehörige Geräte),
-   Weiterleitungs  und Aufnahmesysteme, die für die Verwendung mit brennbaren Anästhesiemitteln nach IEC 60601-2-13:2003, Anhang DD, bestimmt sind.

Systèmes d'anesthésie par inhalation - Partie 3: Systèmes de transfert et de réception des systèmes d'évacuation des gaz d'anesthésie (ISO 8835-3:2007)

L'ISO 8835-3:2007 spécifie les exigences relatives aux systèmes de transfert et aux systèmes de réception des systèmes d'évacuation des gaz d'anesthésie actifs (SEGA actifs), conçus pour réduire l'exposition du personnel de santé aux gaz et aux vapeurs d'anesthésie, tout en protégeant le patient (par exemple contre une pression ou un débit de gaz excessifs).
L'ISO 8835-3:2007 spécifie également les exigences applicables aux systèmes de transfert et de réception des systèmes d'évacuation des gaz d'anesthésie actifs dans lesquels la source d'alimentation fait partie intégrante du système de transfert et de réception.

Inhalacijski anestezijski sistemi - 3. del: Sistemi za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov (ISO 8835-3:2007)

Ta del ISO 8835 določa zahteve za sisteme za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov (AGSS), namenjene za zmanjšanje izpostavljenosti zdravstvenega osebja anestezijskim plinom in hlapom med tem, ko bolnikom nudijo varstvo (npr. pred prevelikim pretokom in pritiskom). Ta del ISO 8835 prav tako določa zahteve za sisteme za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov, v katerih je napajalnik vgrajen v sistem za prenos in sprejem.

General Information

Status
Withdrawn
Publication Date
17-Mar-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
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 8835-3:2009 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)

Relations

Replaces
EN ISO 8835-3:2007 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
Effective Date
23-Mar-2009
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
Amended By
EN ISO 8835-3:2009/A1:2010 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007/AMD 1:2010)
Effective Date
27-Feb-2010

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-3:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 8835-3:2008
Inhalacijski anestezijski sistemi - 3. del: Sistemi za prenos in sprejem sistemov za
odstranjevanje anestezijskih plinov (ISO 8835-3:2007)
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems (ISO 8835-3:2007)
Systeme für die Inhalationsanästhesie - Teil 3: Weiterleitungs- und Aufnahmesysteme
von aktiven Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes de transfert et de réception
des systèmes d'évacuation des gaz d'anesthésie (ISO 8835-3:2007)
Ta slovenski standard je istoveten z: EN ISO 8835-3:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-3:2009

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SIST EN ISO 8835-3:2009
EUROPEAN STANDARD
EN ISO 8835-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 8835-3:2007
English Version
Inhalational anaesthesia systems - Part 3: Transfer and
receiving systems of active anaesthetic gas scavenging systems
(ISO 8835-3:2007)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes Systeme für die Inhalationsanästhesie - Teil 3:
de transfert et de réception des systèmes d'évacuation des Weiterleitungs- und Aufnahmesysteme von aktiven
gaz d'anesthésie (ISO 8835-3:2007) Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007)
This European Standard was approved by CEN on 1 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 8835-3:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8835-3:2009
EN ISO 8835-3:2009 (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 8835-3:2009
EN ISO 8835-3:2009 (E)
Foreword
The text of ISO 8835-3:2007 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 8835-3:2009 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 September 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 8835-3:2007.
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
...

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NOTE 2    This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
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