SIST EN ISO 15002:2008

SLOVENSKI STANDARD
01-september-2008
1DGRPHãþD
SIST EN 13220:2000
3UHWRþQLPHULOQLNL]DSULNOMXþLWHYQDNRQþQHGHOHQDSHOMDY]DPHGLFLQVNHSOLQH,62

Flow-metering devices for connection to terminal units of medical gas pipeline systems
(ISO 15002:2008)
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von
Rohrleitungssystemen für medizinische Gase (ISO 15002:2008)
Dispositifs de mesure de débit pour raccordement aux prises murales des systemes de
distribution de gaz médicaux (ISO 15002:2008)
Ta slovenski standard je istoveten z: EN ISO 15002:2008
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 15002
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2008
ICS 11.040.10 Supersedes EN 13220:1998
English Version
Flow-metering devices for connection to terminal units of
medical gas pipeline systems (ISO 15002:2008)
Dispositifs de mesure de débit pour raccordement aux Durchflussmesseinrichtungen zum Anschluss an
prises murales des systèmes de distribution de gaz Entnahmestellen von Rohrleitungssystemen für
médicaux (ISO 15002:2008) medizinische Gase (ISO 15002:2008)
This European Standard was approved by CEN on 21 June 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 15002:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Annex ZA (informative) Correspondence between this International Standard and Directive
93/42/EEC.4

Foreword
This document (EN ISO 15002:2008) 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 13220:1998.
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 15002:2008 has been approved by CEN as a EN ISO 15002:2008 without any modification.
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
5 1
5.1 2, 6
5.2 2
5.3 2
5.3.1 7.1, 7.3, 9.3
5.3.2 7.3, 9.3
5.3.3 4, 7.1, 9.2
5.3.4 3, 5
5.3.5 7.1, 7.2
5.4 2, 3, 4
5.4.1 9.2, 12.7.4
5.4.1.2 7.2, 7.6
5.4.2 9.2, 12.7.4
5.4.3 9.2, 12.7.1
5.4.4 7.5
5.4.5 9.1
5.4.6.1 10.3, 12.8.2
5.4.6.2 10.2
5.4.6.3 10.1, 12.8.1, 12.8.2
5.4.6.4 12.8.1
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
5.4.7.1 10.3, 12.8.2
5.4.7.2 10.2
5.4.7.3 10.1, 12.8.1, 12.8.2
5.4.7.4 12.8.1
5.4.7.5 10
5.4.8.1 10.2
5.4.8.2 10.1, 12.8.1, 12.8.2
5.4.8.3 10.2
5.5.1 7.2, 9.3
5.5.2 7.3, 9.3
6.2 9.2, 12.7.1, 12.7.4
6.3 7.5
6.4 13.2
7.1 13.1, 13.2, 13.3 a), 13.3 d), 13.5
7.2 13.2
7.3 3, 5
7.3.1 5, 7.2, 7.6
7.3.2 13.1, 13.3 b)
8.1 13.1, 13.3 a), 13.4, 13.6 a)
8.2 13.6 c), 13.6 d)
8.3 1st dash 9.3
8.3 2nd dash 9.1, 12.7.4, 13.6 c)
8.3 3rd dash 9.3
8.3 4th dash 10.1, 12.8.1, 12.8.2
8.3 5th dash 10.1, 12.8.1, 12.8.2
8.3 6th dash 10.1, 12.8.1, 12.8.2
8.3 7th dash 10.1, 12.8.1, 12.8.2
8.3 8th dash 10.1, 12.8.1, 12.8.2

8.3 9th dash 10.1, 12.8.1, 12.8.2
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 15002
Second edition
2008-07-01
Flow-metering devices for connection to
terminal units of medical gas pipeline
systems
Dispositifs de mesure de débit pour raccordement aux prises murales
des systèmes de distribution de gaz médicaux

Reference number
ISO 15002:2008(E)
©
ISO 2008
ISO 15002:2008(E)
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ii © ISO 2008 – All rights reserved

ISO 15002:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 *Normative references. 2
3 Terms and definitions. 2
4 Arrangement of flow-metering systems and devices . 4
5 General requirements. 4
5.1 Safety . 4
5.2 Alternative construction . 4
5.3 Materials . 4
5.4 Design requirements . 5
5.5 Constructional requirements. 10
6 Test methods. 10
6.1 General. 10
6.2 Test method for mechanical strength. 11
6.3 Test method for leakage . 11
6.4 Test method for durability of markings and colour coding. 12
7 Marking, colour coding and packaging.12
7.1 Marking . 12
7.2 Colour coding. 13
7.3 Packaging . 13
8 Information to be supplied by the manufacturer. 13
Annex A (informative) Rationale . 15
Annex B (informative) Arrangements of flow-metering systems and devices . 17
Annex C (informative) Environmental aspects. 20
Bibliography . 21

ISO 15002:2008(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 15002 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 15002:2000) which has been technically
revised.
iv © ISO 2008 – All rights reserved

ISO 15002:2008(E)
Introduction
Flow-metering devices are widely used for delivery of medical gases supplied by a medical gas supply system
directly to a patient. These devices need to deliver accurate flows under varying conditions of temperature and
inlet pressure. Therefore it is important that the operating characteristics be specified and tested in a defined
manner.
This International Standard pays particular attention to:
⎯ safety (mechanical strength, safe relief of excess pressure, resistance to ignition);
⎯ gas specificity;
⎯ cleanliness;
⎯ suitability of materials;
⎯ accuracy;
⎯ testing;
⎯ identification;
⎯ information supplied.
Annex A contains rationale statements for some of the requirements of this International Standard. The
clauses and subclauses marked with an asterix (*) after their number have corresponding rationale contained
in informative Annex A, included to provide additional insight into the reasoning that led to the requirements
and recommendations that have been incorporated in this International Standard. It is considered that
knowledge of the reasons for the requirements will not only facilitate the proper application of this International
Standard, but will expedite any subsequent revisions.

INTERNATIONAL STANDARD ISO 15002:2008(E)

Flow-metering devices for connection to terminal units of
medical gas pipeline systems
1 Scope
1.1 This International Standard is applicable to:
⎯ flow-metering devices that are connected, either directly or by means of flexible connecting assemblies,
and disconnected by the operator at terminal units of a medical gas pipeline system for flow adjustment,
measurement and delivery of medical gases;
⎯ flow-metering devices that are connected and disconnected by the operator at gas-specific connection
points of devices such as pressure regulators.
1.2 This International Standard applies to:
a) flow-metering devices intended to be used with the following medical gases:
⎯ oxygen;
⎯ nitrous oxide;
⎯ medical air;
⎯ carbon dioxide;
⎯ oxygen/nitrous oxide mixture [50 %/50 % (by volume)];
⎯ specified mixtures of the gases listed above;
b) flow-metering devices intended to be used with the following gases:
⎯ oxygen-enriched air;
⎯ helium;
⎯ xenon.
NOTE Regional or national regulations might permit use of oxygen-specific connection points for oxygen-enriched air.
1.3 This International Standard does not apply to electrical or electronic flow-metering devices.
1.4 This International Standard does not apply to gases used for driving surgical tools.
ISO 15002:2008(E)
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 32, Gas cylinders for medical use — Marking for identification of content
ISO 5359:2008, Low-pressure hose assemblies for use with medical gases
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and
vacuum
ISO 9170-1, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 11114-3:1997, Transportable gas cylinders — Compatibility of cylinder and valve materials with gas
contents — Part 3: Autogenous ignition test in oxygen atmosphere
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15001:2003, Anaesthetic and respiratory equipment — Compatibility with oxygen
ISO 19054, Rail systems for supporting medical equipment
EN 837-1:1996, Pressure gauges — Part 1: Bourdon tube pressure gauges — Dimensions, metrology,
requirements and testing
EN 1089-3:2004, Transportable gas cylinders — Gas cylinder identification (excluding LPG) — Part 3: Colour
coding
EN 13544-2, Respiratory therapy equipment — Part 2: Tubing and connectors
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
diameter index safety system connectors
DISS connectors
any of a range of male and female components intended to maintain gas-specificity by allocation of a set of
different diameters to the mating connectors for each particular gas
3.2
flowgauge
device that measures pressure and is calibrated in units of flow
NOTE The flowgauge does not measure flow. It indicates flow by measuring the pressure upstream of a fixed orifice.
3.3
flowmeter
device that measures and indicates the flow of a specific gas
3.4
flow-metering device
device fitted with an inlet connector and an outlet connector and which incorporates one of the following:
a) a flowmeter with a flow control valve;
b) a flowgauge and a fixed orifice with a flow control valve;
2 © ISO 2008 – All rights reserved

ISO 15002:2008(E)
c) one or more fixed orifices with a means of flow selection.
NOTE Typical examples of flow-metering systems and devices are given in Figures B.1 and B.2.
3.5
gas-specific
having characteristics which prevent connections between different gas services
3.6
gas-specific connection point
that part of the socket which is the receptor for a gas-specific probe
3.7
hose insert
that portion of a connector which is pushed into and secured within the bore (lumen) of the hose
3.8
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under his or her own name, regardless of whether these operations are
carried out by that person or on his or her behalf by a third party
3.9
medical gas pipeline system
complete system which comprises a supply system, a monitoring and alarm system and a pipeline distribution
system with terminal units at the points where medical gases or vacuum may be required
3.10
medical gas supply system
either
a) a medical gas pipeline system or
b) an installation having no permanent pipeline system but employing a medical gas supply source complete
with pressure regulator(s)
3.11
non-interchangeable screw-threaded connector
NIST connector
range of male and female components intended to maintain gas specificity by the allocation of a set of
different diameters and a left- or right-hand screw thread to the mating components for each particular gas
3.12
probe
gas-specific male component designed for acceptance by and retention in the socket
3.13
rated inlet pressure
p
maximum upstream pressure for which the flow-metering device is designed to operate
3.14
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
3.15
socket
female part of a terminal unit which is either integral or attached to the terminal unit base block by a
gas-specific interface and which contains the gas-specific connection point
ISO 15002:2008(E)
3.16
terminal unit
outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections
and disconnections
4 Arrangement of flow-metering systems and devices
Typical examples of flow-metering systems are shown in Annex B.
5 General requirements
NOTE Unless otherwise specified, pressures in this International Standard are expressed as gauge pressures
(i.e. atmospheric pressure is defined as 0).
5.1 Safety
Flow-metering devices 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 connected with their intended application, in
normal conditions and in single fault conditions.
5.2 Alternative construction
Flow-metering devices, and components or parts thereof, using materials or having forms of construction
different from those detailed in this clause (except for dimensions and allocation of DISS and NIST connectors
and probes used as inlet connectors), shall be presumed to be in compliance with the safety objectives of this
International Standard 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) unless objective
evidence to the contrary becomes available.
NOTE 1 Objective evidence might be obtained by postmarket surveillance.
Evidence of an equivalent degree of safety shall be provided by the manufacturer upon request.
NOTE 2 Regional or national regulations may require the provision of evidence to a competent authority or conformity
assessment body (e.g. notified body in the European Economic Area) upon request.
NOTE 3 Attention is drawn to ISO 14971 on risk management and to the International Standards under development
by ISO/TC 210.
5.3 Materials
5.3.1 *The materials in contact with the gases listed in 1.2, during normal use, shall be resistant to corrosion
and compatible with oxygen and the other gases and their mixtures in the temperature range specified in 5.3.3.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials that burn in air burn
violently in pure oxygen. Many materials that do not burn in air will do so in pure oxygen, particularly under pressure.
Similarly, materials that can be ignited in air, require lower ignition energies in oxygen. Many such materials can be ignited
by friction at a valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a
system initially at low pressure.
NOTE 3 ISO 15001 contains information on selection of metallic and non-metallic materials and other aspects of
compatibility of equipment with oxygen.
4 © ISO 2008 – All rights reserved

ISO 15002:2008(E)
5.3.2 *For flow-metering devices for all gases, the autoignition temperature of the non-metallic components
in contact with the gas, including the sealing materials and lubricants (if used), shall be no lower than 160 °C.
Evidence of conformity with this requirement shall be provided by the manufacturer upon request.
NOTE 1 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.
The determination of the autoignition temperature shall be carried out in accordance with ISO 11114-3.
NOTE 2 The maximum permitted operating temperature of tested material is 100 °C lower than the autoignition
temperature at the corresponding oxygen pressure. This safety margin is necessary because it covers both an unforeseen
increase in the operating temperature and the fact that the autoignition temperature is not a constant. Values of the
autoignition temperature always depend on the test method used, which does not exactly simulate all possible operating
conditions.
5.3.3 The materials shall permit the flow-metering device and its components to meet the requirements of
5.4 (except 5.4.6.3, 5.4.7.3 and 5.4.8.2) in the temperature range of −20 °C to +60 °C.
5.3.4 Flow-metering devices shall meet the requirements of 5.4 after being exposed, whilst packed for
transport and storage, to environmental conditions as specified by the manufacturer.
5.3.5 Springs, highly strained components and parts liable to wear which come in contact with the gas shall
not be plated.
NOTE Plating could come off.
5.3.6 Evidence of conformity with the requirements of 5.3.1 to 5.3.5 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.
5.4 Design requirements
5.4.1 Gas supply inlet
5.4.1.1 Inlet
The gas supply inlet shall be one of the following:
a) a probe complying with ISO 9170-1 permanently attached to the flow-metering device [see Figure B.2 a)];
b) a nut and nipple, either complying with DISS or NIST specifications in ISO 5359, or complying with an
equivalent regional or national standard, permanently attached to the flow-metering device [see
Figure B.2 b)];
c) a low-pressure hose assembly complying with ISO 5359 with a probe complying with ISO 9170-1 as an
inlet connector and a flow-metering device as an outlet connector [see Figure B.2 c)];
d) a low-pressure hose assembly complying with ISO 5359 with a nut and nipple either complying with DISS
or NIST specifications in ISO 5359, or complying with an equivalent national or regional standard, as an
inlet connector and a flow-metering device as an outlet connector [see Figure B.2 d)].
ISO 15002:2008(E)
5.4.1.2 Filtration
A gas supply inlet shall be provided with a filter which:
a) is replaceable;
b) has openings not exceeding 100 µm or equivalent mesh.
Evidence of conformity 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.
5.4.2 Outlet connector
The outlet connector shall be one of the following:
a) a fixed nipple in accordance with EN 13544-2;
b) a threaded connector in accordance with EN 13544-2 or equivalent regional or national standard;
c) a proprietary fitting, with or without a hose insert.
Compliance shall be checked by visual inspection.
5.4.3 *Mechanical strength
The flow-metering device shall meet the requirements of 5.4.4 and 5.4.6.3, 5.4.7.3 and 5.4.8.2 after containing
a pressure of 1 000 kPa for 5 min.
The test for mechanical strength is given in 6.2.
5.4.4 Leakage
The total internal leakage with the flow control valve closed with a torque of 0,4 N⋅m (or in the case of a
flow-metering device with multiple fixed orifices, with the means of selection set to zero) shall not exceed
0,3 ml/min (which is equivalent to 0,030 3 kPa⋅l/min) at p , after the tests for mechanical strength
...