SIST EN ISO 8835-3:2009

SLOVENSKI STANDARD
SIST EN ISO 8835-3:2009
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
SIST EN ISO 8835-3:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-3:2009

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SIST EN ISO 8835-3:2009
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.

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SIST EN ISO 8835-3:2009
EN ISO 8835-3:2009 (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 8835-3:2009
EN ISO 8835-3:2009 (E)
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
EN ISO 8835-3:2009 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 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.
3

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SIST EN ISO 8835-3:2009
EN ISO 8835-3:2009 (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 - 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.



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SIST EN ISO 8835-3:2009

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

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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
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ii © ISO 2007 – All rights reserved

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SIST EN ISO 8835-3:2009
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. 9
Annex B (informative) Typical test arrangement and method for sub-atmospheric pressure
limitation . 13
Annex C (informative) Typical test arrangement and method for testing of induced flow. 14
Annex D (informative) Typical test arrangement and method for resistance to extract flow. 15
Annex E (informative) Typical test arrangement and method for spillage. 17
Annex F (informative) Rationale . 20
Annex G (informative) Environmental aspects . 22
Bibliography . 23

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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(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 8835-3 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This second edition cancels and replaces the first edition (ISO 8835-3:1997), 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
iv © ISO 2007 – All rights reserved

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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
Introduction
This part of ISO 8835 is intended to ensure that, for all practical purposes, an active AGSS will remove
essentially all gases delivered to it and thereby reduce atmospheric pollution to a small fraction of the
uncontrolled level.
It is recognized that there are many factors affecting conditions within the operator’s working environment,
which are outside the control of manufacturers of active AGSSs. These include room ventilation, leakage from
equipment and the choice of anaesthetic technique, all of which are variable. Furthermore, the amount of
pollutant taken up by personnel will be affected by other factors, such as the duration of exposure, their
position in relation to any source of pollution, etc.
Atmospheric pollution by anaesthetic gases is the subject of considerable discussion, and opinions differ as to
the limits that should be allowed in the working environment. Recommendations on permissible levels are
therefore not included in this part of ISO 8835 but can be specified in national standards.
The committee responsible for this part of ISO 8835 has been primarily concerned with limiting the risks to the
patient, which the transfer and receiving systems of AGSS can introduce by altering the function of breathing
systems. The wide range of anaesthetic machines, ventilators and related equipment in general use today has
been taken into account.
Annex F 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 F,
included to provide additional insight into the reasoning that led to the requirements and recommandations
that have been incorporated in this International Standard.

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SIST EN ISO 8835-3:2009

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SIST EN ISO 8835-3:2009
INTERNATIONAL STANDARD ISO 8835-3:2007(E)

Inhalational anaesthesia systems —
Part 3:
Transfer and receiving systems of active anaesthetic gas
scavenging systems
* 1 Scope
This part of ISO 8835 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). This part of
ISO 8835 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.
This part of ISO 8835 does not specify requirements for
⎯ disposal systems which are covered by ISO 7396-2,
⎯ non-active AGSSs (passive AGSSs),
⎯ proximity gas extraction systems (i.e. systems not directly connected to the breathing system or
associated equipment),
⎯ transfer and receiving systems intended for use with flammable anaesthetic 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 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 connections
ISO 5359:2000, Low-pressure hose assemblies for use with medical gases
ISO 7000:2004, Graphical symbols for use on equipment — Index and synopsis
ISO 7396-2, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
ISO 8835-2, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
1)
ISO 9170-2:— , Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic gas
scavenging systems
ISO 21647, Medical electrical equipment — Particular requirements for the basic safety and essential
performance of respiratory gas monitors
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
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, IEC 60601-2-13 and the
following apply.
3.1
anaesthetic gas scavenging system
AGSS
system that is connected to the exhaust port of an anaesthetic breathing system, or to associated equipment,
or which is integrated into an anaesthetic system (workstation) for the purpose of conveying expired and
excess anaesthetic gases (3.3) to an appropriate place of discharge
NOTE Functionally, an anaesthetic gas scavenging system comprises three different parts: a transfer system, a
receiving system and a disposal system. These three functionally discrete parts can be either separate or sequentially
combined in part or in total. In addition, one or more parts of an anaesthetic gas scavenging system can be sequentially
combined with an anaesthetic breathing system (e.g. as in an anaesthetic ventilator) to include the transfer system or
transfer and receiving system.
3.2
active anaesthetic gas scavenging system
active AGSS
anaesthetic gas scavenging system (3.1) in which the gas flow in the disposal system (3.4) results from a
powered device
3.3
anaesthetic gas
gas and/or vapour of a volatile agent used in anaesthesia
3.4
disposal system
that part of an active AGSS (3.2) by means of which the expired or excess anaesthetic gases (3.3) are
conveyed from the receiving system (3.14) to the point of discharge by a power device (3.13)
NOTE The point of discharge can be, for example, the exterior of a building or a non-recirculating extract ventilation
system.

1) To be published. (Revision of 9170-2:1999)
2 © ISO 2007 – All rights reserved

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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
3.5
disposal hose
that part of a disposal system (3.4) which conveys expired and/or excess anaesthetic gases (3.3) and
vapours from the power device (3.13) to the probe of an AGSS type 2 terminal unit
3.6
extract flow
flow of gas from the transfer system (3.16) and receiving system (3.14) of an AGSS (3.1) at the entry to the
disposal system (3.4)
3.7
high-flow transfer and receiving system
transfer system (3.16) and receiving system (3.14) complying with this part of ISO 8835, which connects
through a 1L AGSS (3.1) terminal unit as specified in ISO 9170-2 to a high-flow disposal system (3.4)
complying with ISO 7396-2
3.8
induced flow
flow at the inlet of the transfer system (3.16), which is generated by the power device (3.13) in the disposal
system (3.4)
3.9
low-flow transfer and receiving system
transfer system (3.16) and receiving system (3.14) complying with this part of ISO 8835, which connects
through a 1L AGSS (3.1) terminal unit as specified in ISO 9170-2 to a low-flow disposal system (3.4)
complying with ISO 7396-2
3.10
maximum extract flow
highest flow of gas at the entry to the disposal system (3.4) that can be accommodated without exceeding
the specified limitations for induced flow (3.8)
3.11
minimum extract flow
lowest flow of gas at the entry to the disposal system (3.4) that ensures that the specified limit of spillage
(3.15) to atmosphere is not exceeded
3.12
non-operator-detachable connector
connector that is either permanent or can be separated only with the use of a tool
3.13
power device
that part of the disposal system (3.4) of an active AGSS (3.2) which generates the extract flow (3.6)
3.14
receiving system
that part of an AGSS (3.1) which provides an interface between the transfer system (3.16) and the disposal
system (3.4)
3.15
spillage
volume of expired and/or excess anaesthetic gas (3.3) which cannot be accommodated by the AGSS (3.1)
over a specified period
3.16
transfer system
that part of an AGSS (3.1) which transfers expired and/or excess anaesthetic gases (3.3) from the exhaust
port of a breathing system, or associated equipment, to the receiving system (3.14)
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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
3.17
transfer tube
that part of an AGSS transfer system (3.16) which transfers expired and/or excess anaesthetic gases (3.3)
from the exhaust port of a breathing system, or associated equipment, to the receiving system (3.14)
4 General requirements and alternative test methods
4.1 Materials
All components of the AGSS shall be made of materials that are compatible with the gases and anaesthetic
agents with which these components are designed to come into contact. These components shall also be
designed and manufactured from materials that minimize the leaching of substances during normal use.
4.2 Means of pressure relief
The means of pressure relief, if provided, shall be accessible for cleaning and/or servicing.
NOTE When the means of pressure relief is actuated, gases might be spilled into the atmosphere.
4.3 Alternative test methods
The manufacturer may use type tests different from those described within 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 shall be used as the reference methods.
* 5 Patient and environmental protection
5.1 Normal operating conditions
* 5.1.1 Pressure
With a flow of 75 l/min of test gas into the inlet of the AGSS, the pressure at the inlet shall not exceed 350 Pa
(3,5 cm H O). This requirement shall also be met when there is no extract flow at the outlet of the receiving
2
system (e.g. when the power device is inoperative or disconnected from the receiving system).
NOTE If this requirement is met by means of pressure relief, the spillage requirements might not be met.
* 5.1.2 Induced flow
The effect of operating the AGSS at the maximum extract flow specified for the transfer and receiving system
shall be such that the induced flow at the inlet to the AGSS shall not exceed 50 ml/min.
* 5.1.3 Sub-atmospheric pressure
The effect of operating the AGSS at the maximum extract flow specified for the transfer and receiving system
shall be such that the sub-atmospheric pressure at the inlet of the receiving system shall not exceed
50 Pa (0,5 cm H O).
2
5.1.4 Spillage to atmosphere
With an input of test gas to the inlet of the transfer and receiving system at a frequency of 20 cycles/min,
an I to E ratio 1:1 and a tidal volume of 1 l, spillage to atmosphere shall not exceed 100 ml/min.
NOTE See Annex E for possible test arrangements.
4 © ISO 2007 – All rights reserved

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SIST EN ISO 8835-3:2009
ISO 8835-3:2007(E)
5.1.5 Leakage
The lea
...