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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
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
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 with EN 60601-2-13:2006, replace EN 740:1998 in total, 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 ISO 8835-4:2004, Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery devices (ISO
8835-4:2004)
– EN ISO 8835-5:2004, Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
Attention is also drawn to ISO/TS 18835:2004, Inhalational anaesthesia systems — Draw-over vaporizers and
associated equipment.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 8835-3:2007 has been approved by CEN as a EN ISO 8835-3:2009 without any modification.
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 on medical devices.
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, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All 2, 12.7.4
st
4.1 7.5 (1 paragraph) This relevant Essential Requirement is
not completely addressed in this EN.
nd st nd
11, 12 1, 2 paragraph, 1 and 2 dash These relevant Essential
Requirements are not fully addressed
in this EN
11, 12 13.1
11, 12 13.3 b)
11 d) 13.6 h)
13.6 q) This relevant Essential Requirement is
not addressed in this EN
12 b) 13.3 a) This relevant Essential Requirement is
not completely addressed in this EN
Warning – Other requirements and other EU Directives may be applicable to the products falling within the
scope of this International standard.
INTERNATIONAL ISO
STANDARD 8835-3
Second edition
2007-08-15
Inhalational anaesthesia systems —
Part 3:
Transfer and receiving systems of active
anaesthetic gas scavenging systems
Systèmes d'anesthésie par inhalation —
Partie 3: Systèmes de transfert et de réception des systèmes
d'évacuation des gaz d'anesthésie
Reference number
ISO 8835-3:2007(E)
©
ISO 2007
ISO 8835-3:2007(E)
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ISO 8835-3:2007(E)
Contents Page
Foreword. iv
Introduction . v
* 1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and alternative test methods. 4
4.1 Materials . 4
4.2 Means of pressure relief . 4
4.3 Alternative test methods. 4
* 5 Patient and environmental protection . 4
5.1 Normal operating conditions. 4
5.2 Single fault conditions . 5
* 6 Connectors . 5
* 7 Transfer systems . 5
7.1 Inlet of transfer systems . 5
7.2 Outlet of transfer systems . 6
* 8 Receiving systems. 6
8.1 General. 6
8.2 Inlet of receiving systems. 6
8.3 Outlet of receiving systems. 7
8.4 Visual indicator . 7
8.5 Particle filter . 7
8.6 Receiving hoses. 7
9 Extract flow resistance. 7
9.1 Low-flow transfer and receiving systems . 7
9.2 High-flow transfer and receiving systems . 7
10 Electrical requirements . 8
* 11 Information to be supplied by the manufacturer. 8
12 Marking . 8
* 13 Colour coding. 8
Annex A (informative) Typical test arrangement and method for pressure measurement at inlet to
AGSS.
...
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