ISO 15002:2000
(Main)Flow-metering devices for connection to terminal units of medical gas pipeline systems
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
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 15002
First edition
2000-12-01
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 15002:2000(E)
©
ISO 2000
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ISO 15002:2000(E)
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ISO 15002:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Arrangement of flow-metering systems and devices .4
5 General requirements.6
5.1 Safety .6
5.2 R Alternative construction.6
5.3 Materials .6
5.4 Design requirements .6
5.5 Constructional requirements.9
6 Test methods.9
6.1 General.9
6.2 Test method for mechanical strength .10
6.3 Test method for accuracy of flowrate.10
6.4 Test method for leakage .11
6.5 Test method for loosening and operating torques .11
6.6 Test method for durability of markings and colour coding .11
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.14
Bibliography.15
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ISO 15002:2000(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 15002 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas systems.
Annex A of this International Standard is for information only.
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ISO 15002:2000(E)
Introduction
This International Standard pays particular attention to:
� safety (mechanical strength, safe relief of excess pressure, resistance to ignition);
� gas specificity;
� cleanliness of materials;
� suitability of materials;
� accuracy;
� testing;
� identification;
� information supplied.
Throughout this International Standard, a subclause for which a rationale is provided in annex A is indicated by a
boldface capital R.
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INTERNATIONAL STANDARD ISO 15002:2000(E)
Flow-metering devices for connection to terminal units of medical
gaspipelinesystems
1 Scope
1.1 This International Standard is applicable to:
� flow-metering devices which 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 measurement and delivery
of medical gases;
� flow-metering devices which are connected and disconnected by the operator at gas-specific connection points
of devices such as pressure regulators.
1.2 It applies only to flow-metering devices for the following medical gases:
� oxygen,
� nitrous oxide,
� air for breathing,
� carbon dioxide,
� helium,
� xenon,
� specified mixtures of the gases listed above,
� oxygen/nitrous oxide mixture 50/50 (% volume fraction).
1.3 This International Standard is not applicable to electrical or electronic flow-metering devices.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 32, Gas cylinders for medical use — Marking for identification of content.
ISO 5359, Low-pressure hose assemblies for use with medical gases.
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ISO 15002:2000(E)
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, Medical devices — Application of risk management to medical devices.
EN 12218, Rail systems for supporting medical equipment.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
DISS connectors
diameter index safety system connectors
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
flow gauge
gauge which measures pressure differential and which is calibrated in units of flowrate
NOTE The flow gauge indicates flowrate 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 that incorporates one of the following:
a) a flowmeter and flow control valve
b) a flow gauge and a fixed orifice with a flow control valve
c) multiple fixed orifices with means of selection
3.5
gas-specific
having characteristics which prevent interchangeability and thereby allow assignment to one gas or vacuum service
only
3.6
gas-specific connection point
that part of the socket which is the receptor for a gas-specific probe
3.7
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 own name, regardless of whether these operations are carried out by that person
himself or on his behalf by a third party
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ISO 15002:2000(E)
3.8
medical gas
any gas or mixture of gases intended for administration to patients for therapeutic, diagnostic or prophylactic
purposes, or for surgical tool applications
3.9
medical gas pipeline system
complete system which comprises a source of supply, a pipeline distribution system and terminal units at the points
where medical gases or vacuum may be used
3.10
medical gas supply system
medical gas pipeline system or any other installation having no permanent pipeline system but employing a medical
gas source complete with pressure regulator(s)
3.11
NIST connectors
non-interchangeable screw-threaded connectors
range of male and female components intended to maintain gas specificity by allocation of a set of different
diameters and a left-hand or right-hand screw thread to the mating components for each particular gas
3.12
placing on the market
the first making available, in return for payment or free of charge, of a device other than a device intended for
clinical investigation, with a view to distribution and/or use
3.13
probe
male component designed for acceptance by and retention in the socket
3.14
rated inlet pressure
p
1
maximum upstream pressure for which the flow-metering device is designed to operate
NOTE Unless otherwise specified, pressures in this International Standard are expressed as gauge pressures
(i.e. atmospheric pressure is defined as 0).
3.15
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
3.16
socket
that female part of a terminal unit which is either integral or attached to the base block by a gas-specific interface
and which contains the gas-specific connection point
3.17
terminal unit
outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections and
disconnections
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ISO 15002:2000(E)
4 Arrangement of flow-metering systems and devices
4.1 Typical examples of flow-metering systems are shown in Figure 1.
a) Measuring tube with flow control valve downstream b) Measuring tube with flow control valve upstream
c) Paddle and a fixed orifice with flow control valve d) Paddle and a fixed orifice with flow control valve
downstream upstream
e) Flow gauge and a fixed orifice with flow control valve f) Multiple fixed orifices with selection knob
upstream
Figure 1 — Examples of flow-metering systems
Figure 1 a) shows a system which comprises a vertical measuring tube whose cross-section increases upwards
and in which a float is lifted by the action of the gas flow. The float settles at a height which is a function of the
flowrate, which is controlled by a flow control valve fitted downstream of the tube.
Figure 1 b) shows the same system as in a) with the flow control valve fitted upstream of the tube.
Figure 1 c) shows a system which comprises a paddle connected to a return spring which is located at the outlet of
a fixed orifice. The paddle is pushed by the action of the gas flow and settles at a position which is a function of the
flowrate, which is controlled by a flow control valve fitted downstream of the orifice.
Figure 1 d) shows the same system as in c) with the flow control valve fitted upstream of the orifice.
Figure 1 e) shows a system which comprises a pressure gauge measuring the pressure upstream of a fixed orifice.
The pressure is a function of the flowrate, which is controlled by a flow control valve fitted upstream of the pressure
gauge. The pressure gauge is calibrated in units of flowrate (flow gauge).
Figure 1 f) shows a system which comprises multiple fixed orifices. The change from the "off" position and from one
setting to another can be achieved, for example, by turning a knob.
4.2 Typical examples of flow-metering devices are shown in Figure 2.
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ISO 15002:2000(E)
a) Flow-metering device with a probe as inlet connector
b) Flow-metering device with a DISS or NIST nut and nipple as inlet connector
c) Flow-metering device with a hose and a probe as inlet connector
d) Flow-metering device with a hose and a DISS or NIST nut and nipple as inlet connector
Key
1 Flow control valve
2 Inlet connector
3 Outlet connector
4 Measuring tube
5Hose
Figure 2 — Typical examples of flow-metering devices
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ISO 15002:2000(E)
5 General requirements
5.1 Safety
Flow-metering devices 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 ISO 14971, which is connected with their intended application, in normal condition
and in single fault condition.
5.2 R Alternative construction
Flow-metering devices and components or parts thereof, using materials or having forms of construction different
from those detailed in clause 5 of this International Standard (except for dimensions and allocation of DISS and
NIST connectors and probes used as inlet connectors) shall be accepted if it can be demonstrated that an
equivalent degree of safety is obtained.
Such evidence shall be provided by the manufacturer.
5.3 Materials
5.3.1 The materials in contact with the gas shall be compatible with oxygen and the intended medical gas or gas
mixture in the temperature range specified in 5.3.2.
NOTE 1 Compatibility with oxygen involves both combustibility and ease of ignition. Materials which burn in air will burn
violently in pure oxygen. Many materials which do not burn in air will do so in pure oxygen, particularly under pressure. Similarly,
materials which can be ignited in air require lower ignition energies in oxygen. Many such materials may 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 2 Compatibility with oxygen includes resistance
...
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