EN ISO 8835-2:2009
(Main)Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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 8835-2:2007 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
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 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.
Annex RR of EN 740:1998 (Method of test for draw-over vaporizers used with emergency anaesthetic
equipment) is not superseded.
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 8835-2:2007 has been approved by CEN as a EN ISO 8835-2:2009 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 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/Subclause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (Ers) of EU Directive
93/42/EEC
All 1 to 6
The relevant Essential
Requirement 7.5, 1st
paragraph, is not fully
addressed in this EN.
1 to 6 and 7 (except 7.4 and
4.1
7.5, 2nd and 3rd paragraphs)
The relevant Essential
Requirements 7.5 (2nd and 3rd
paragraphs) are not addressed
in this EN.
This relevant Essential
- 6a) Requirement is not addressed
in this EN.
4.2 9.2
4.3 12.6
5 9, 12.7, 12.9
5.2 9, 12.7
6 9, 12.7
7 9.2, 12.7, 12.8
8.1 9, 12.9
8.2 to 8.4 9, 12.8
9.1 9, 12.7
9.2, 9.3 9, 12.7, 12.8
9.4 9
10 9, 10
11 9
Table ZA.1 (continued)
Clause(s)/Subclause(s) of Essential Requirements Qualifying remarks/Notes
this European Standard (Ers) of EU Directive
93/42/EEC
The relevant Essential
9 and 13 (except 13.6 h and Requirements 13.3 a) and 13.3
13.6q) f) are not fully addressed in this
EN.
The relevant Essential
Requirements 13.3 a) and 13.3
f) are not fully addressed in this
EN.
The relevant Essential
13 9 and 13
Requirements 13.6 h), 2nd
paragraph, last two sentences
and 13.6 q) are not addressed
in this EN
WARNING - Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 8835-2
Third edition
2007-08-15
Inhalational anaesthesia systems —
Part 2:
Anaesthetic breathing systems
Systèmes d'anesthésie par inhalation —
Partie 2: Systèmes respiratoires d'anesthésie
Reference number
ISO 8835-2:2007(E)
©
ISO 2007
ISO 8835-2:2007(E)
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ISO 8835-2:2007(E)
Contents Page
Foreword. v
Introduction . vi
* 1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General. 3
4.1 Materials . 3
4.2 Anaesthetic breathing system component packaging . 3
4.3 Electrical requirements . 3
4.4 Alternative test methods. 4
5 Connection ports . 4
5.1 Patient connection port. 4
5.2 Y-Piece . 4
5.3 Exhaust connection port. 4
5.4 Interchangeable non-rebreathing exhaust valves. 4
* 5.5 Reservoir bag connection port. 4
5.6 Anaesthetic ventilator connection port. 5
5.7 Connection ports of interchangeable anaesthetic breathing system components. 5
* 5.8 Inspiratory and expiratory connection ports of an interchangeable circle absorber
assembly. 5
5.9 Other connection ports . 5
6 Reservoir bag/anaesthetic ventilator selector switch. 5
7 Complete anaesthetic breathing system either supplied assembled or assembled in
accordance with the manufacturer’s instructions . 5
* 7.1 Leakage. 5
* 7.2 Inspiratory and expiratory pressure/flow characteristics . 6
8 Interchangeable anaesthetic breathing system components — Exhaust valves . 6
8.1 Direction of movement of controls . 6
8.2 Pressure/flow characteristics. 6
8.3 Opening pressure . 6
8.4 Leakage.
...
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