SIST EN ISO 9170-2:2008

Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

This part of ISO 9170 specifies the requirements and dimensions for terminal units intended for use in anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2. This par t of ISO 9170 specifies two types of terminal unit according to whether the power device is upstream or downstream of the terminal unit. This part of ISO 9170 also specifies requirements and dimensions for the mating counterpart (probe) of the type-specific connection point which is part of the terminal unit. This part of ISO 9170 does not specify the ranges of nominal operating pressure for terminal units, which are defined in IS O 7396-2. This part of ISO 9170 does not specify requirements for terminal units for use with compressed medical gases and vacuum, which are covered in ISO 9170-1.

Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 2: Entnahmestellen für Anästhesiegas-Fortleitungssysteme (ISO 9170-2:2008)

1.1 Dieser Teil von ISO 9170 legt die Anforderungen und Maße für Entnahmestellen fest, die zur Verwendung in Anästhesiegas-Fortleitungssystemen zur Entsorgung nach ISO 7396 2 vorgesehen sind.
1.2 In diesem Teil von ISO 9170 werden zwei Typen von Entnahmestellen spezifiziert, je nachdem, ob sich das Antriebssystem in Strömungsrichtung vor oder hinter der Entnahmestelle befindet.
1.3 Dieser Teil von ISO 9170 legt auch Anforderungen und Maße für das passende Gegenstück (Stecker) der typspezifischen Verbindungsstelle fest, die Teil einer Entnahmestelle ist.
1.4 Dieser Teil von ISO 9170 legt nicht die Bereiche für Nenn-Betriebsdrücke für Entnahmestellen fest, die in ISO 7396 2 festgelegt sind.

Prises murales pour réseaux de distribution de gaz médicaux - Partie 2: Prises murales pour systemes d'évacuation des gaz d'anesthésie (ISO 9170-2:2008)

L'ISO 9170-2:2008 spécifie les exigences et les dimensions des prises murales destinées à être utilisées dans les systèmes d'évacuation des gaz d'anesthésie conformément à l'ISO 7396-2.
L'ISO 9170-2:2008 spécifie deux types de prises murales pour une utilisation où le dispositif moteur se trouve soit en amont soit en aval de la prise murale.
L'ISO 9170-2:2008 spécifie également les exigences et les dimensions des contreparties s'y emboîtant (embout) du raccord de type spécifique qui fait partie de la prise murale.

Končni deli napeljav za medicinske pline - 2. del: Končni deli sistemov za odstranjevanje anestezijskih plinov in hlapov (ISO 9170-2:2008)

General Information

• Status: Published
• Publication Date: 12-Aug-2008
• Withdrawal Date: 31-Oct-2006
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jul-2008
• Due Date: 05-Sep-2008
• Completion Date: 13-Aug-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 9170-2:2008 - Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)

Relations

• Replaces: SIST EN 737-4:2000 - Medical gas pipeline systems - Part 4: Terminal units for anaesthetic gas scavenging systems
• Effective Date: 01-Sep-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 9170-2:2008
01-september-2008
1DGRPHãþD
SIST EN 737-4:2000
.RQþQLGHOLQDSHOMDY]DPHGLFLQVNHSOLQHGHO.RQþQLGHOLVLVWHPRY]D
RGVWUDQMHYDQMHDQHVWH]LMVNLKSOLQRYLQKODSRY,62
Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic
gas scavenging systems (ISO 9170-2:2008)
Entnahmestellen für Rohrleitungssysteme für medizinische Gase - Teil 2:
Entnahmestellen für Anästhesiegas-Fortleitungssysteme (ISO 9170-2:2008)
Prises murales pour réseaux de distribution de gaz médicaux - Partie 2: Prises murales
pour systemes d'évacuation des gaz d'anesthésie (ISO 9170-2:2008)
Ta slovenski standard je istoveten z: EN ISO 9170-2:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 9170-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 9170-2:2008

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SIST EN ISO 9170-2:2008
EUROPEAN STANDARD
EN ISO 9170-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.10 Supersedes EN 737-4:1998
English Version
Terminal units for medical gas pipeline systems - Part 2:
Terminal units for anaesthetic gas scavenging systems (ISO
9170-2:2008)
Prises murales pour systèmes de distribution de gaz Entnahmestellen für Rohrleitungssysteme für medizinische
médicaux - Partie 2: Prises murales pour systèmes Gase - Teil 2: Entnahmestellen für Anästhesiegas-
d'évacuation des gaz d'anesthésie (ISO 9170-2:2008) Fortleitungssysteme (ISO 9170-2:2008)
This European Standard was approved by CEN on 15 May 2008.
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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9170-2:2008: E
worldwide for CEN national Members.

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SIST EN ISO 9170-2:2008
EN ISO 9170-2:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4

2

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SIST EN ISO 9170-2:2008
EN ISO 9170-2:2008 (E)
Foreword
This document (EN ISO 9170-2:2008) 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 January 2009, and conflicting national standards shall be withdrawn at
the latest by July 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 737-4:1998.
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.
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 9170-2:2008 has been approved by CEN as a EN ISO 9170-2:2008 without any modification.
3

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SIST EN ISO 9170-2:2008
EN ISO 9170-2:2008 (E)
Annex ZA
(informative)

Correspondence between this International Standard and
Directive 93/42/EEC
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC 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 normative
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 International Standard and Directive 93/42/EEC
Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC

4 1

4.1 2, 6
4.2 2
4.3 2
4.3.1 7.1, 7.3, 9.3

4.3.2 4, 9.2

4.3.3 3, 5
4.4 2, 3, 4
4.4.1 12.7.4
4.4.2 9.1, 12.7.4

4.4.3 12.8.2

4.4.4 9.1, 12.7.4
4.4.5 9.1, 12.7.4
4.4.6 12.7.4
4.4.8 9.1

4.4.9 9.2, 12.7.4

4.4.10 9.2, 12.7.4
4.4.11 9.2, 12.7.1, 12.7.4
4.4.12 7.5
4.4.13 9.1, 12.7.4

4

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SIST EN ISO 9170-2:2008
EN ISO 9170-2:2008 (E)

Table ZA.1 (continued)

Clause(s)/Sub-clause(s) of Corresponding essential requirements Qualifying remarks/Notes
this International Standard of EU Directive 93/42/EEC
4.4.14 9.1, 12.7.4
4.4.15 12.7.4
4.4.16 9.1, 12.7.4

4.4.17 12.6
4.5.1 7.2, 9.3
4.5.2 7.3, 9.3
5.2 12.7.4
5.3 9.1

5.4 9.2, 12.7.4
5.5 9.2, 12.7.4
5.6 9.2, 12.7.1, 12.7.4
5.7 7.5
5.8 9.1, 12.7.4

5.9 9.1, 12.7.4
5.10 9.2, 12.7.1, 12.7.4
5.11 13.2
6.1 13.2
6.1.3 13.1, 13.3 a), 13.3 d), 13.5

6.2 13.2
6.3 3, 5
6.3.1 5, 7.2, 7.6
6.3.2 13.1, 13.3 b)
7.1 13.1, 13.3 a), 13.4, 13.6 a)

7.2 7.6, 9.1, 12.7.4, 13.6 c), 13.6 d)
7.3 2, 13.1, 13.6 d), 13.6 h)
7.4 1st dash 9.3
7.4 2nd dash 9.2, 13.6 I)
7.4 3rd dash 9.1, 12.7.4, 13.6 c)

WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
5

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SIST EN ISO 9170-2:2008

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SIST EN ISO 9170-2:2008

INTERNATIONAL ISO
STANDARD 9170-2
Second edition
2008-07-01


Terminal units for medical gas pipeline
systems —
Part 2:
Terminal units for anaesthetic gas
scavenging systems
Prises murales pour systèmes de distribution de gaz médicaux —
Partie 2: Prises murales pour systèmes d'évacuation des gaz
d'anesthésie





Reference number
ISO 9170-2:2008(E)
©
ISO 2008

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
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©  ISO 2008
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ii © ISO 2008 – All rights reserved

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 * Normative references .1
3 Terms and definitions .3
4 General requirements .7
4.1 Safety.7
4.2 * Alternative construction.7
4.3 Materials .7
4.4 Design requirements.7
4.5 Construction requirements .14
5 Test methods .14
5.1 General .14
5.2 Endurance test.14
5.3 Test method for pressure drop .15
5.4 Test method for connection force .15
5.5 Test method for disconnection force .15
5.6 Tests for mechanical strength .16
5.7 Tests for leakage .16
5.8 Test for type specificity .16
5.9 Test for effective connection of probes to sockets .16
5.10 Test for connection of receiving or disposal hoses to hose inserts .16
5.11 Test for durability of markings and colour coding .16
6 Marking, colour coding and packaging.16
6.1 Marking.16
6.2 Colour coding .17
6.3 Packaging.17
7 Information to be supplied by the manufacturer .17
Annex A (informative) Rationale.18
Annex B (informative) Environmental aspects .19
Annex C (informative) Special national and regional conditions for electrical installations.21
Bibliography.22

© ISO 2008 – All rights reserved iii

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(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 9170-2 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 9170-2:1999) which has been technically
revised.
ISO 9170 consists of the following parts, under the general title Terminal units for medical gas pipeline
systems:
⎯ Part 1: Terminal units for use with compressed medical gases and vacuum
⎯ Part 2: Terminal units for anaesthetic gas scavenging systems
iv © ISO 2008 – All rights reserved

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
Introduction
Anaesthetic gas scavenging system (AGSS) terminal units are the points in an anaesthetic gas scavenging
system where the operator makes connections and disconnections for the disposal of medical gases and
anaesthetic vapours from anaesthetic machines or other items of medical equipment, and where a wrong
connection may create a hazard to the patient. It is important that terminal units and their components be
designed, manufactured, installed and maintained in such a way as to meet the basic requirements specified
in this part of ISO 9170.
This part of ISO 9170 pays particular attention to:
⎯ suitability of materials;
⎯ type specificity;
⎯ dimensions of probes and type-specific connection points;
⎯ cleanliness;
⎯ testing;
⎯ identification;
⎯ information supplied.
This part of ISO 9170 specifies the provision of information for the installation and subsequent testing of
terminal units. Testing of terminal units prior to use is critical to patient safety and it is essential that terminal
units are not used until full testing in accordance with ISO 7396-2 has been completed.
Annex A contains rationale statements for some of the requirements of this part of ISO 9170. The clauses and
subclauses marked with an asterisk (*) after their number have corresponding rationale contained in Annex A,
included to provide additional insight into the reasoning that led to the requirements and recommendations
that have been incorporated in this part of ISO 9170. It is considered that knowledge of the reasons for the
requirements will not only facilitate the proper application of this part of ISO 9170, but will expedite any
subsequent revisions.

© ISO 2008 – All rights reserved v

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SIST EN ISO 9170-2:2008

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SIST EN ISO 9170-2:2008
INTERNATIONAL STANDARD ISO 9170-2:2008(E)

Terminal units for medical gas pipeline systems —
Part 2:
Terminal units for anaesthetic gas scavenging systems
1 Scope
1.1 This part of ISO 9170 specifies the requirements and dimensions for terminal units intended for use in
anaesthetic gas scavenging disposal systems in accordance with ISO 7396-2.
1.2 This part of ISO 9170 specifies two types of terminal unit according to whether the power device is
upstream or downstream of the terminal unit.
1.3 This part of ISO 9170 also specifies requirements and dimensions for the mating counterpart (probe) of
the type-specific connection point which is part of the terminal unit.
1.4 This part of ISO 9170 does not specify the ranges of nominal operating pressure for terminal units,
which are defined in ISO 7396-2.
1.5 This part of ISO 9170 does not specify requirements for terminal units for use with compressed medical
gases and vacuum, which are covered in ISO 9170-1.
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 6506-1:2005, Metallic materials — Brinell hardness test — Part 1: Test method
ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
ISO 8835-3:2007, Inhalational anaesthesia systems — Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
© ISO 2008 – All rights reserved 1

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)

Key
1 type-specific connection
2 hose insert (permanent)
3 point for brazed connection (permanent)
4 terminal unit base block
5 type-specific interface
6 terminal unit check valve (Type 1 only)
7 type-specific connection point
8 socket
9 type-specific probe
Figure 1 — Diagram of a typical AGSS terminal unit
2 © ISO 2008 – All rights reserved

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE A diagram of a typical AGSS terminal unit with an example of terminology is given in Figure 1.
3.1
AGSS Type 1 terminal unit
connection point between the receiving system and disposal system at which the operator makes connections
and disconnections
See Figure 2.
3.2
AGSS Type 1L terminal unit
terminal unit to be used in low-flow disposal systems
3.3
AGSS Type 1H terminal unit
terminal unit to be used in high-flow disposal systems
3.4
AGSS Type 2 terminal unit
connection point between the power device or disposal hose and the remainder of the disposal system at
which the operator makes connections and disconnections
See Figure 2.
3.5
AGSS type-specific
having characteristics which prevent interchangeability and thereby allow assignment to one AGSS type only
3.6
AGSS type-specific connection point
that part of the AGSS socket which is the receptor for an AGSS type-specific probe
3.7
anaesthetic gas scavenging system
AGSS
complete system that is connected to the exhaust port(s) of a breathing system or other equipment for the
purpose of conveying expired and/or excess anaesthetic gases to an appropriate place of discharge
NOTE Functionally, an AGSS comprises three different parts: a transfer system, a receiving system and a disposal
system. These three functionally discrete parts may be either separate or sequentially combined in part or in total. In
addition, one or more parts of an AGSS can be combined with a breathing system or other equipment to include the
transfer system or transfer and receiving systems. See Figure 2.
3.8
terminal unit check valve
valve that remains closed until opened by insertion of an appropriate probe and which then flows in either
direction
3.9
disposal hose
that part of the AGSS which transfers expired and/or excess anaesthetic gases from the power device to the
probe of the AGSS Type 2 terminal unit
© ISO 2008 – All rights reserved 3

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)

4 © ISO 2008 – All rights reserved

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
Key
1 apparatus including breathing system, integral transfer/receiving system and power device
2 apparatus including breathing system
3 transfer/receiving system and power device
4 apparatus including breathing system and integral transfer/receiving system
5 permanent or proprietary connector
6 receiving hose
7 breathing system or anaesthetic ventilator
8 transfer tube
9 receiving system
10 power device
11 permanent connection
12 discharge
13 flexible hose or pendant
14 disposal hose
15 limit of breathing system
16 limit of transfer system
17 limit of receiving system
18 limit of disposal system
19 proprietary connection (functionally specific)
20 30 mm conical connection
21 type 1 terminal unit probe/socket
22 type 2 terminal unit probe/socket
NOTE 1 Type 1 terminal unit probe/socket is for negative pressure. Type 2 terminal unit probe/socket is for positive
pressure.
NOTE 2 The limit between the receiving system and the disposal system as shown may not coincide with an actual
physical limit such as a wall.
Figure 2 — Schematic diagram of typical anaesthetic gas scavenging systems
3.10
disposal system
means by which expired and/or excess anaesthetic gases are conveyed from the receiving system to an
appropriate place of discharge
NOTE A place of discharge can be, for example, the exterior of a building or a non-recirculating extract ventilation
system.
3.11
high-flow disposal system
disposal system that is intended to operate with a high-flow transfer and receiving system complying with
ISO 8835-3
3.12
low-flow disposal system
disposal system that is intended to operate with a low-flow transfer and receiving system complying with
ISO 8835-3
3.13
maximum test pressure
maximum pressure to which the terminal unit is designed to be subjected during pipeline pressure testing
© ISO 2008 – All rights reserved 5

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
3.14
operating pressure
pressure at which the AGSS terminal unit is designed to operate
NOTE The operating pressure for a Type 1 AGSS terminal unit is negative; the operating pressure for a Type 2
AGSS terminal unit is positive.
3.15
power device
that part of the AGSS disposal system that provides power for scavenging at specified flows and pressures
3.16
probe
non-interchangeable male component designed for acceptance by, and retention in, a socket
3.17
quick connector
pair of non-threaded type-specific components that can be easily and rapidly joined together by a single action
of one or both hands without the use of tools
3.18
receiving hose
that part of an AGSS which transfers expired and/or excess anaesthetic gases from the receiving system to
the disposal system
3.19
receiving system
that part of an AGSS which provides an interface between a transfer system and a disposal system
3.20
single-fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
3.21
socket
that female part of a terminal unit which is either integral or attached to the base block by a type-specific
interface and which contains the type-specific connection point
3.22
terminal unit base block
that part of a terminal unit which is attached to the disposal system
3.23
terminal unit check valve
valve that remains closed until opened by the insertion of an appropriate probe and which then permits flow in
either direction
3.24
transfer system
that part of an AGSS which transfers scavenged gases from the exhaust port of a breathing system or other
equipment to a receiving system
3.25
transfer tube
that part of an AGSS that transfers expired and/or excess anaesthetic gases from the breathing system or
other equipment to the receiving system
6 © ISO 2008 – All rights reserved

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SIST EN ISO 9170-2:2008
ISO 9170-2:2008(E)
4 General requirements
4.1 Safety
Terminal units shall, when transported, stored, installed, operated in normal use and maintained according to
the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using
procedures in accordance with ISO 14971 and which are related to their intended application, in normal
conditions and in single-fault condition.
NOTE Maintenance of equipment is considered a normal condition.
4.2 * Alternative construction
Terminal units and components, or parts thereof, that use materials or have forms of construction (except for
dimensions and allocation of probes and type-specific connection points) different from those detailed in this
clause, shall be presumed to be in compliance with the safety objectives of this part of ISO 9170 if it can be
demonstrated that an equivalent degree of safety is obtained (i.e. compliance with requirements presumes
that risks have been mitigated to acceptable levels), and unless objective evidence to the contrary becomes
available.
Evidence of an equivalent degree of safety shall be provided by the manufacturer upon request.
NOTE 1 Objective evidence may be obtained by postmarket surveillance.
NOTE 2 Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.
4.3 Materials
4.3.1 The materials in contact with the gas shall be corrosion-resistant and compatible with the medical
gases and anaesthetic vapours in the temperature range specified in 4.3.2.
NOTE Corrosion resistance includes resistance to moisture and surrounding materials.
4.3.2 The materials shall permit the terminal units and their components to meet the requirements of 4.4 in
the temperature range −20 °C to +60 °C.
4.3.3 Terminal units shall be capable of meeting the requirements of 4.4 after being packed, transported
and stored as specified by the manufacturer.
4.3.4 Evidence of conformity with the requirements of 4.3.1, 4.3.2 and 4.3.3 shall be provided by the
manufacturer upon request.
NOTE Regional or national regulations might require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.
4.4 Design requirements
4.4.1 Retention of type specificity
If any type-specific component is removed from the terminal unit, the
...