EN ISO 8835-2:2007

SLOVENSKI STANDARD
01-april-2008
1DGRPHãþD
SIST EN 740:2000
SIST EN 740:2000/A1:2005
SIST EN 740:2000/AC:2000
Inhalacijski anestezijski sistemi - 2. del: Anestezijski dihalni sistemi za odrasle
(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)
Systemes d'anesthésie par inhalation - Partie 2: Systemes respiratoires d'anesthésie
(ISO 8835-2:2007)
Ta slovenski standard je istoveten z: EN ISO 8835-2:2007
ICS:
11.040.10
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 8835-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2007
ICS 11.040.10 Supersedes EN 740:1998
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 9 June 2007.
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.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8835-2:2007: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 8835-2:2007) 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 February 2008, and conflicting national
standards shall be withdrawn at the latest by May 2009.
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.
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.
Attention is drawn to the possibility that some of the elements of this document may be the
subject of patent rights. CEN shall not be held responsible for identifying any or all such
patent rights.
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 United
Kingdom.
Endorsement notice
The text of ISO 8835-2:2007 has been approved by CEN as EN ISO 8835-2:2007 without any
modifications.
ANNEX ZA
(informative)
Relationship between this 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 to conforming to
Essential Requirements of the New Approach Directive 93/42/EEC, Council Directive of 14
June 1993 on the approximation of the laws of the Member States concerning medical
devices (Medical Device Directive).

Once this European 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 European Standard given in Table ZA.1
confers, within the limits of the scope of this European Standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this International Standard and EU Directive
93/42/EEC
Clause(s)/sub-clause(s) of Essential requirements (ERs) of EU Qualifying remarks/Notes
this International Standard Directive 93/42/EEC
All 1 to 6
4.1 1 to 6, and 7
4.2 1 to 6, and 9.2
4.3 1 to 6, and 12.6
4.4
5 1 to 6, 9 and 12.7
6 1 to 6, 9 and 12.7
7 1 to 6, 9.2 and 12.7
8.1 1 to 6, 9 and 12.7
8.2 1 to 6, 9 and 12.9
8.2.2 1 to 6, and 9
8.2.3 1 to 6, 9 and 12.7
9.1 1 to 6, and 9
9.2 1 to 6, 9 and 12.7
9.3 1 to 6, 9, 12.7 and 12.9
9.4 1 to 6, and 9
9.5.1 1 to 6, and 9
9.5.2 1 to 6, and 9
9.5.3 1 to 6, and 9
9.5.4 1 to 6, and 9
9.5.5 1 to 6, and 9
10 1 to 6, 9 and 10
11 1 to 6, and 9
12 1 to 6, 9 and 13
13 1 to 6, 9 and 13
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. 6
9 Circle absorber assemblies . 6
9.1 Construction. 6
9.2 Absorbent bypass mechanism. 7
9.3 Pressure/flow characteristics. 7
9.4 Inspiratory and expiratory valves . 7
10 Pressure monitoring and limitation . 8
10.1 Pressure monitoring. 8
10.2 Pressure-limiting device . 8
* 11 Location of components in an anaesthetic breathing sy
...