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The European Standard EN 737-4:1998 has the status of a
British Standard
ICS 11.040.10
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
Medical gas pipeline
systems
Part 4: Terminal units for anaesthetic gas
scavenging systems
Trang 2This British Standard, having
been prepared under the
direction of the Health and
Environment Sector Board, was
published under the authority of
the Standards Board and comes
into effect on 15 May 1998
Amendments issued since publication
with BS EN 737-2:1998 and clause 111 of BS EN 740:1998, it supersedes
BS 6834:1987, which will be withdrawn in due course
The UK participation in its preparation was entrusted by Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems and hose assemblies, to Subcommittee CH/44/2, Medical gas supply systems, which has the responsibility to:
± aid enquirers to understand the text;
± present to the responsible international/European committee any enquiries
on the interpretation, or proposals for change, and keep the UK interests informed;
± monitor related international and European developments and promulgate them in the UK
A list of organizations represented on this subcommittee can be obtained on request
to its secretary
Cross-references
The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled ªInternational Standards Correspondence Indexº, or by using the ªFindº facility of the BSI Standards Electronic Catalogue
A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application
Compliance with a British Standard does not of itself confer immunity from legal obligations.
Summary of pages
This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 14, an inside back cover and a back cover
Trang 3European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung
Central Secretariat: rue de Stassart 36, B-1050 Brussels
1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members
Ref No EN 737-4:1998 E
ICS 11.040.10; 23.040.60; 23.060.01
Descriptors: Gas distribution, disposal, medical gases, anaesthesia, junctions, walls, definitions, materials, design, tests, marking,
colour codes, packing
English version
Medical gas pipeline systems Ð Part 4: Terminal units for anaesthetic gas scavenging systems
SysteÁmes de distribution de gaz meÂdicaux Ð Partie
4: Prises murales pour systeÁmes d'eÂvacuation des
gaz d'anestheÂsie
Rohrleitungssysteme fuÈr medizinische Gase Ð Teil 4: Entnahmestellen fuÈr
AnaÈsthesiegas-Fortleitungssysteme
This European Standard was approved by CEN on 5 July 1997
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 Central Secretariat 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 Central Secretariat has the
same status as the official versions
CEN members are the national standards bodies of Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and
United Kingdom
Trang 4This European Standard has been prepared by
Technical Committee CEN/TC 215, Respiratory and
anaesthetic equipment, of which the Secretariat 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 July 1998, and
conflicting national standards shall be withdrawn at
the latest by July 1998
This European Standard 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)
EN 737 consists of the following parts under the
general title Medical gas pipeline systems.
Part 1: Terminal units for compressed medical gases
and vacuum
Part 2: Anaesthetic gas scavenging disposal systems
Part 3: Pipelines for compressed medical gases and
vacuum
Part 5: Oxygen concentrators
Part 6: Dimensions of probes for terminal units for
compressed medical gases and vacuum.
Annexes A and B are informative
For relationship with EU Directive(s), see informative
annex ZA, which is an integral part of this standard
According to the CEN/CENELEC Internal Regulations,
the national standards organizations of the following
countries are bound to implement this European
Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom
Contents
Page
8 Information to be supplied by the
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU
Trang 5Introduction
Anaesthetic gas scavenging system (AGSS) terminal
units are the points in an AGSS 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 life of a patient
It is important that terminal units and their
components are designed, manufactured, installed and
maintained in such a way as to meet the basic
requirements specified in this part of this European
Standard
This part of this European Standard pays particular
attention to:
± suitability of materials;
± type-specificity;
± dimensions of probes and type-specific connection
points;
± cleanliness;
± testing;
± identification;
± information supplied
In any healthcare facility, it is strongly recommended
that terminal units of only one type are used for any
particular service
This part of this European Standard specifies the
provision of information for the installation and testing
of terminal units Testing after installation is critical to
patient safety and it is essential that terminal units are
not used until full testing in accordance with
prEN 737-2 has been completed
Rationales for some of the requirements of this part of
this European Standard are given in annex B These
requirements are indicated by the letter ªRº after the
clause number
1 Scope
This part of this European Standard specifies
requirements and dimensions for terminal units
intended for use in anaesthetic gas scavenging systems
specified in prEN 737-2 for the scavenging of medical
gases and anaesthetic vapours
It is intended especially to ensure the type-specific
assembly of terminal units and to prevent their
interchange between different services
This part of this European Standard 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 this European Standard does not specify
the ranges of nominal operating pressures for terminal
units (see prEN 737-2)
This part of this European Standard specifies two
types of terminal units which are non-interchangeable,
for use where the power device is upstream or
downstream of the terminal unit Figure 1 shows the
use of the two types of terminal unit
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications These normative references are cited at the
appropriate places in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision For undated references, the latest edition of the publication referred to applies
prEN 737-2, Medical gas pipeline systems Ð Part 2: Anaesthetic gas scavenging disposal systems
EN 1441, Medical devices Ð Risk analysis ISO 554, Standard atmospheres for conditioning and/or testing Ð Specifications
3 Definitions
For the purposes of this part of this European Standard, the following definitions apply
3.1 AGSS Type 1 terminal unit
connection point between the receiving system and disposal system at which an operator makes connections and disconnections
3.2 AGSS Type 2 terminal unit
connection point between the power device or the disposal hose and the remainder of the disposal system
at which an operator makes connections and disconnections
3.3 anaesthetic gas scavenging system; AGSS
system which is connected to the exhaust port(s) of an anaesthetic workstation, or which is integrated into an anaesthetic workstation, 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 may be sequentially combined with a breathing system to include the transfer system or transfer and receiving system.
3.4 disposal hose
that part of an AGSS which transfers expired and/or excess gases from the power device to the probe of an AGSS Type 2 terminal unit
3.5 disposal system
means by which the expired and/or excess anaesthetic gases are conveyed from the receiving system to an appropriate place of discharge
NOTE A place of discharge may be, e.g the exterior of a building
or a non-recirculating exhaust ventilation system.
Trang 61
2 3 4 5 6 7 8 9 10
Apparatus including breathing system and integral transfer/receiving system and power device
Apparatus including breathing system Transfer/receiving system and power device Apparatus including breathing system and integral transfer/receiving system Permanent or proprietary connector Receiving hose
Breathing system or anaesthetic ventilator Transfer tube
Receiving system Power device
11 12 13 14 15 16 17 18 19 20 21 22
Permanent connection Discharge
Flexible hose or pendant Disposal hose
Limit of breathing system Limit of transfer system Limit of receiving system Limit of disposal system Proprietary connection (functionally specific)
30 mm conical connection Type 1 terminal unit probe/socket Type 2 terminal unit probe/socket NOTE 1 Type 1 terminal unit is for negative pressure Type 2 terminal unit 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 In the arrangement shown, a terminal unit on
a wall would be located on the outlet of the power device.
Figure 1 Ð Schematic diagram of typical anaesthetic gas scavenging systems
Trang 73.6
maximum operating pressure
maximum pressure at which a terminal unit is
designed to operate
NOTE Operating pressure for Type 1 is negative, and for Type 2 is
positive.
3.7
maximum test pressure
maximum pressure to which a terminal unit is
designed to be subject during pipeline pressure testing
3.8
power device
that part of the disposal system of an AGSS which
provides the gas flow for scavenging
3.9
probe
non-interchangeable male component designed for
acceptance by, and retention in, the socket
3.10
quick connector
pair of non-threaded type-specific components which
can be easily and rapidly joined together by a single
action of one or both hands without the use of tools
3.11
receiving hose
that part of an AGSS which transfers expired and/or
excess gases from the receiving system to the disposal
system
3.12
receiving system
that part of an AGSS which provides an interface
between the transfer system and the disposal system,
and may contain means of sub-atmospheric and/or
positive pressure relief
3.13
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
3.14
socket
that 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
3.15
terminal unit base block
that part of a terminal unit which is attached to the
disposal system
3.16 terminal unit check valve
valve which remains closed until opened by insertion
of an appropriate probe, and which then permits flow
in either direction
3.17 transfer system
that part of an AGSS, which may or may not incorporate tubing, which transfers expired and/or excess anaesthetic gases from the exhaust port of the anaesthetic breathing system and/or anaesthetic ventilator to the receiving system, and which can contain a means of pressure relief
3.18 transfer tube
that part of an AGSS which transfers expired and/or excess gases from the anaesthetic breathing system and/or anaesthetic ventilator to the receiving system
3.19 type-specific
having characteristics which prevent interchangeability and thereby allow assignment to one type only
3.20 type-specific connection point
that part of a socket which is the receptor for a typespecific probe
4 Terminology
A diagram of a typical terminal unit, with examples of terminology, is given in Figure 2
5 General requirements
5.1 Safety
Terminal units shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk analysis procedures in accordance with EN 1441 and which is connected with their intended
application, in normal condition and in single fault condition
5.2R Alternative construction
Terminal units and components or parts thereof, using materials or having forms of construction (except for dimensions and allocation of probes and the
type-specific connection points) different from those detailed in this part of this European Standard, shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained
Such evidence shall be provided by the manufacturer
Trang 81 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 Probe
Figure 2 Ð Diagram of a typical AGSS terminal unit
Trang 95.3 Materials
5.3.1 The materials in contact with the gas shall be
compatible with the medical gases and anaesthetic
vapours in the temperature range specified in 5.3.2.
NOTE Corrosion resistance includes resistance against moisture
and surrounding materials.
5.3.2 The materials shall permit the terminal units and
their components to meet the requirements of 5.4 in
the temperature range of 220 8C to +60 8C
5.3.3 Terminal units shall be capable, while packed
for transport and storage, of being exposed to
environmental conditions as stated by the
manufacturer
5.3.4R Evidence of conformity with the requirements
of 5.3.1, 5.3.2 and 5.3.3 shall be provided by the
manufacturer
5.4 Design requirements
5.4.1 Incomplete assembly
If any type-specific component is removed from the
terminal unit, either the terminal unit shall be rendered
inoperable or the type-specificity of the terminal unit
shall be maintained
If the terminal unit can be dismantled, the components
shall not be capable of being reassembled in such a
way that the fully assembled terminal unit is no longer
type-specific
5.4.2 Type-specific connection point
Each terminal unit shall include a type-specific
connection point which shall accept the appropriate
type-specific probe only This connection point shall be
included in a socket
5.4.3 Terminal unit check valve
Each Type 1 terminal unit socket shall include a check
valve which shall open when the probe is connected
and which shall shut off automatically when the probe
is disconnected
5.4.4 Connection of terminal units to the disposal
system
5.4.4.1 The base block of the terminal unit shall be
designed and manufactured for either permanent or
type-specific connection to a pipeline (See also 8.2).
5.4.4.2 Such type-specific connections shall be
incompatible with those used for compressed medical
gases and vacuum pipeline systems, hose assemblies,
breathing systems and other AGSS components
5.4.5 Connection of receiving or disposal hoses to
hose inserts
5.4.5.1 Hoses shall be attached to the hose inserts of
connectors by means of compression swaging, a
crimped ferrule or other method which permits
compliance with 5.4.5.2 and 5.4.5.3.
5.4.5.2 It shall be impossible to remove the fitted
sleeve or ferrule without it becoming unfit for re-use
5.4.5.3 The connection shall withstand the application
of a steady axial tensile force of 600 N for 60 s
The test is given in 6.10.
5.4.6 Socket
The arrangement for attaching a socket to its base block for a particular service shall be of a design which prevents interchangeability with the base block
of any other service
5.4.7 Test methods for compliance
Compliance with 5.4.1 to 5.4.6 (except for 5.4.5.3)
shall be tested by visual inspection and functional testing where applicable
5.4.8 Pressure drop
The pressure drop across the terminal unit and its probe shall not exceed the values given in Table 1
The test for pressure drop is given in 6.3.
Table 1 Ð Requirements for flow and pressure drop across terminal units with probe inserted
Terminal unit type
Test pressure Test
flow
Maximum pressure drop across a terminal unit
5.4.9 Connection force
The force required to insert the probe into the terminal unit shall be an axial force not exceeding 100 N
The test for connection force is given in 6.4.
5.4.10 Disconnection force
The force required to release the locking mechanism shall be a push or pull of not more than 110 N and not less than 20 N
When all locking provisions have been released, according to the manufacturer's instructions, disconnection of the probe from the terminal unit shall require a force of not more than 100 N
The test for disconnection force is given in 6.5.
5.4.11 Mechanical strength
The terminal unit shall comply with the requirements
of clause 5 following the application of a steady axial
tensile force of 500 N
The test for mechanical strength is given in 6.6.
5.4.12 Leakage
The leakage from a terminal unit, with and without probe inserted, shall not exceed 2,96 ml/min (0,3 kPa´l/min)
The test for leakage is given in 6.7.
5.4.13 Type-specificity
The terminal unit shall only accept the type-specific probe for which it is intended
The test for type-specificity is given in 6.8.
5.4.14 Effective connection of probes
A tactile or audible indication of locking shall be perceived on retention of the type-specific probe
The test for effective connection of probes is given
in 6.9.
Trang 10Dimensions in millimetres
1 Probe sealing area
NOTE 3 All diameters to be concentric to within 0,05 mm.
NOTE 5 All sharp edges and burrs to be removed (maximum radius 0,2 mm) unless otherwise specified.
Figure 3 Ð Dimensions of Type 1 probe and type-specific connection point
5.4.15.1 Socket
The terminal unit shall meet the requirements given
in 5.4.8, 5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13
and 5.4.14 after testing in accordance with 6.2.1.
5.4.15.2 Probe
The probe shall meet the requirements given in 5.4.8,
5.4.9, 5.4.10, 5.4.11, 5.4.12, 5.4.13 and 5.4.14 after
testing in accordance with 6.2.2.
5.4.16 Dimensions
The dimensions of the Type 1 probe and the
corresponding type-specific connection point shall
comply with Figure 3
The dimensions of the Type 2 probe and the
corresponding type-specific connection point shall
comply with Figure 4
Compliance shall be verified by measurement
5.5.1R Cleaning
The components of terminal units shall be supplied clean and free from oil, grease and particulate matter
Evidence shall be provided by the manufacturer
NOTE 1 Any method of cleaning and degreasing can be used which effectively removes all surface dirt and hydrocarbons, and which leaves no residue itself Chemical cleaning methods normally require a subsequent washing and drying process to remove residues.
NOTE 2 Examples of cleaning procedures will be described in a
standard, Compatibility of medical equipment with oxygen,
which is in preparation by ISO/TC 121/SC 6.
5.5.2R Lubricants
If lubricants are used, they shall be compatible with medical gases and anaesthetic vapours in the
temperature range specified in 5.3.2.
Evidence shall be provided by the manufacturer