SIST 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)
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 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
SIST EN ISO 8835-2:2009
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
SIST EN ISO 8835-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8835-2:2009
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SIST EN ISO 8835-2:2009
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.
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SIST EN ISO 8835-2:2009
EN ISO 8835-2:2009 (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 8835-2:2009
EN ISO 8835-2:2009 (E)
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
EN ISO 8835-2:2009 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 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.
3
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SIST EN ISO 8835-2:2009
EN ISO 8835-2:2009 (E)
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
4
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SIST EN ISO 8835-2:2009
EN ISO 8835-2:2009 (E)
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
12
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.
5
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SIST EN ISO 8835-2:2009
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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
ISO 8835-2:2007(E)
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ii © ISO 2007 – All rights reserved
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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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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SIST EN ISO 8835-2:2009
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 co
...
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