SIST EN ISO 8835-2:2008
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
This part of ISO 8835 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. It 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. This part of ISO 8835 does not cover the performance of anaesthetic breathing systems regarding the elimination of expired carbon dioxide since this is complex and depends on the interaction of the patient, the fresh gas flow, the carbon dioxide absorbent and the anaesthetic breathing system itself. This part of ISO 8835 does not apply to anaesthetic breathing systems intended for use with flammable anaesthetic agents/gases as determined by Annex DD of IEC 60601-2-13:2003.
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 Anästhesiesystem eingebaut sind, einschließlich des Weges eines Anästhesie Beatmungsgeräts für ausgeatmetes Gas und der Teile eines nicht vom Anwender abnehmbaren Anästhesiegas Fortleitungssystems (AGFS).
Dieser Teil von ISO 8835 behandelt nicht die Leistung von 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 Atemsystem selbst abhängt.
Dieser Teil von ISO 8835 gilt nicht für Atemsysteme, die für die Verwendung mit brennbaren Anästhesiemitteln bzw. gasen vorgesehen sind.
Systemes d'anesthésie par inhalation - Partie 2: Systemes respiratoires d'anesthésie (ISO 8835-2:2007)
Inhalacijski anestezijski sistemi - 2. del: Anestezijski dihalni sistemi za odrasle (ISO 8835-2:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8835-2:2008
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
SIST EN ISO 8835-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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.
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EN ISO 8835-2:2007 (E)
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.
2
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EN ISO 8835-2:2007 (E)
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
3
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EN ISO 8835-2:2007 (E)
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.
4
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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
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ISO 8835-2:2007(E)
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ii © ISO 2007 – All rights reserved
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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 system containing a circle absorber
assembly (as defined in 3.3) . 8
11.1 Exhaust valve . 8
11.2 Reservoir bag connection port. 8
11.3 Fresh gas inlet. 8
11.4 Inspiratory and expiratory valves . 8
12 Marking . 9
© ISO 2007 – All rights reserved iii
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ISO 8835-2:2007(E)
12.1 Marking of complete anaesthetic breathing systems and anaesthetic breathing system
components. 9
12.2 Marking of packages. 10
13 Information to be provided by the manufacturer or supplier. 10
13.1 General . 10
13.2 For anaesthetic breathing systems supplied complete. 10
13.3 For anaesthetic breathing system components . 11
Annex A (normative) Typical test arrangements and methods . 13
Annex B (informative) Rationale . 18
Annex C (informative) Environmental aspects . 20
Annex D (normative) Antistatic requirements . 21
Bibliography . 22
iv © ISO 2007 – All rights reserved
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ISO 8835-2:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8835-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This third edition cancels and replaces the second edition (ISO 8835-2:1999), which has been technically
revised.
ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
⎯ Part 2: Anaesthetic breathing systems
⎯ Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems
⎯ Part 4: Anaesthetic vapour delivery devices
⎯ Part 5: Anaesthetic ventilators
© ISO 2007 – All rights reserved v
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ISO 8835-2:2007(E)
Introduction
An anaesthetic breathing system comprises an assembly of tubes and connectors and may include valves, a
reservoir bag and a circle absorber assembly. Other items of equipment (e.g. humidifiers, filters, spirometers,
thermometers, gas analysers) may be incorporated into an anaesthetic breathing system.
Its function is to convey mixtures of gases to and from the patient.
Annex A gives typical test arrangements and methods. Annex B gives the rationale for some of the
requirements found within this part of ISO 8835.
Annex B contains rationale statements for some of the requirements of this part of ISO 8835. The clauses and
subclauses marked with an asterix (*) before their number have corresponding rationale contained in Annex B,
included to provide additional insight into the reasoning that led to the requirements and recommendations
that have been incorporated in this International Standard.
Annex C lists the clauses of this part of ISO 8835 that address the environmental aspects of the device.
vi © ISO 2007 – All rights reserved
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INTERNATIONAL STANDARD ISO 8835-2:2007(E)
Inhalational anaesthesia systems —
Part 2:
Anaesthetic breathing systems
* 1 Scope
This part of ISO 8835 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.
It 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.
This part of ISO 8835 does not cover the performance of anaesthetic breathing systems regarding the
elimination of expired carbon dioxide since this is complex and depends on the interaction of the patient, the
fresh gas flow, the carbon dioxide absorbent and the anaesthetic breathing system itself.
This part of ISO 8835 does not apply to anaesthetic breathing systems intended for use with flammable
anaesthetic agents/gases as determined by Annex DD of IEC 60601-2-13:2003.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 2878:2005, Rubber — Antistatic and conductive products — Determination of electrical resistance
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-
bearing connectors
ISO 5362, Anaesthetic reservoir bags
ISO 5367, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7000:2004, Graphical symbols for use on equipment — Index and synopsis
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
© ISO 2007 – All rights reserved 1
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ISO 8835-2:2007(E)
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-2-13:2003, Medical electrical equipment — Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 and IEC 60601-2-13 and the
following apply.
3.1
anaesthetic breathing system
ABS
those inspiratory and expiratory pathways through which gas flows at respiratory pressure between the fresh
gas inlet (3.6), the patient connection port (3.9) and the exhaust valve (3.5) or exhaust port (3.4)
3.2
circle absorber assembly
that part of a circle breathing system (3.3) which comprises one or more carbon-dioxide-absorbent
containers, inspiratory and expiratory valves or other means of ensuring unidirectional gas flow, two ports for
connection to breathing tubes, a fresh gas inlet (3.6), a reservoir bag port and/or an anaesthetic ventilator
port
3.3
circle breathing system
anaesthetic breathing system (3.1) in which the direction of gas flow through inspiratory and expiratory
pathways is unidirectional and in which the two pathways form a circle
3.4
exhaust port
that port through which waste gas(es) are discharged to the atmosphere or to an anaesthetic gas scavenging
system (AGSS)
3.5
exhaust valve
valve through which waste gas(es) are discharged to the atmosphere or to an AGSS
NOTE Such a valve can or might not be an adjustable pressure-limiting (APL) valve.
3.6
fresh gas inlet
that port through which fresh gas is supplied to the anaesthetic breathing system (3.1)
3.7
interchangeable component
operator-detachable anaesthetic breathing system component designed to be used with specified equipment
from different manufacturers
3.8
non-rebreathing exhaust valve
exhaust valve (3.5) with three ports, namely an inlet port for connection to a breathing tube or ABS
component, a patient connection port (3.9) and an exhaust port (3.4), the function of the valve being to
prevent exhaled gas from re-entering the anaesthetic breathing system (3.1)
2 © ISO 2007 – All rights reserved
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ISO 8835-2:2007(E)
3.9
patient connection port
that port at the patient end of an anaesthetic breathing system (3.1) intended for connection to devices such
as a tracheal or tracheostomy tube connector, or the connector to a face mask or supraglottic device
3.10
Y-piece
three-way connector with a patient connection port (3.9) and two ports for connection to breathing tubes
4 General
4.1 Materials
All components of an anaesthetic breathing system shall be designed and manufactured in such a way as to
reduce to a minimum the risks posed by substances leaching from them.
When selecting materials for components of anaesthetic breathing systems, manufacturers should take
particular care to ensure compatibility of the materials with the gases and anaesthetic agents with which they
are intended to come into contact.
4.2 Anaesthetic breathing system component packaging
Anaesthetic breathing system components shall be packaged in such a way as to minimize the risk of
incomplete removal of the packaging before use.
NOTE 1 This is to prevent accidental retention of the packaging (e.g. transparent wrapper, caps, lids, covers, etc.) and
to ensure its removal by the operator prior to use.
NOTE 2 Attention is drawn to IEC 60601-1-6 which requires a usability engineering process. Completion of this
process will ensure that such risks are minimized to an acceptable level.
4.3 Electrical requirements
* 4.3.1 General
If the anaesthetic breathing system incorporates electrically powered components, the system shall comply
with applicable parts of IEC 60601-1 and IEC 60601-1-2.
Anaesthetic breathing systems and anaesthetic breathing system components which incorporate RF wireless
technology should be assessed for the following risks:
⎯ electromagnetic compatibility (EMC);
⎯ performance of wireless functions;
⎯ wireless coexistence;
⎯ wireless quality of service;
⎯ integrity of data transmitted wirelessly;
⎯ security of data transmitted wirelessly;
⎯ wireless network access.
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ISO 8835-2:2007(E)
4.3.2 Electrical conductivity
Anaesthetic breathing systems and anaesthetic breathing system components marked as “antistatic” or
“conductive” shall comply with Annex D when tested as described in ISO 2878.
NOTE See 12.1 h) for marking requirements.
4.4 Alternative test methods
The manufacturer may use type tests different from those described in this part of ISO 8835 if an equivalent
degree of compliance can be demonstrated. However, in the event of dispute, the test arrangements and
methods described in this part of ISO 8835 should be used as the reference methods.
5 Connection ports
5.1 Patient connection port
The patient connection port shall be a coaxial male 22 mm/female 15 mm conical connector complying with
ISO 5356-1.
NOTE The patient connection port can be designed so that it will swivel.
5.2 Y-Piece
The machine ends of a Y-piece not permanently attached to breathing tubes shall be either 22 mm male
conical connectors complying with ISO 5356-1 or other connectors compatible with breathing tubes complying
with ISO 5367.
5.3 Exhaust connection port
The exhaust connection port shall be one of the following:
a) a 30 mm male conical connector complying with ISO 5356-1, for connection to an interchangeable AGS
transfer and receiving system and with means of preventing connection of the orifice to any anaesthetic
breathing system component;
b) a proprietary fitting incompatible with connectors complying with ISO 5356-1 and breathing tubes
complying with ISO 5367, for connection to a non-interchangeable anaesthetic gas scavenging (AGS)
transfer and receiving system;
c) non-operator-detachable from the anaesthetic gas scavenging transfer system.
NOTE See 12.1 c) for marking requirements.
5.4 Interchangeable non-rebreathing exhaust valves
The inlet connection port shall be a female 22 mm conical connection complying with ISO 5356-1.
The patient connection port shall comply with 5.1
The exhaust connection port shall comply with 5.3
* 5.5 Reservoir bag connection port
The reservoir bag connection port shall be compatible with a reservoir bag complying with ISO 5362 and a
breathing tube complying with ISO 5367.
4 © ISO 2007 – All rights reserved
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