ANS ISO 15002

Approved as an American National Standard with deviation by ASTM International ANS/ISO

15002 (MOD)First edition2000-12-01

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

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Approved as an American National Standard with deviation by ASTM International ANS/ISO 15002:2000(E)

MOD in ANS/ISO 15002 means that ASTM International has approved the standard as an American National Standard with deviations. The U.S. deviations are appended to the end of ANS/ISO 15002.

© ASTM International These materials are subject to copyright claims of ASTM International. Not for resale without the prior written permission of ASTM International. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASTM International.

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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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Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (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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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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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 which are connected, either directly or by means of flexible connecting assemblies, anddisconnected by the operator at terminal units of a medical gas pipeline system for measurement and delivery ofmedical gases;

flow-metering devices which are connected and disconnected by the operator at gas-specific connection points ofdevices 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 ofthis International Standard. For dated references, subsequent amendments to, or revisions of, any of thesepublications do not apply. However, parties to agreements based on this International Standard are encouraged toinvestigate the possibility of applying the most recent editions of the normative documents indicated below. Forundated references, the latest edition of the normative document referred to applies. Members of ISO and IECmaintain 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 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 isplaced on the market under his own name, regardless of whether these operations are carried out by that personhimself or on his behalf by a third party

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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 p1 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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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 downstream

d) Paddle and a fixed orifice with flow control valve upstream

e) Flow gauge and a fixed orifice with flow control valve upstream

f) Multiple fixed orifices with selection knob

Figure 1 — Examples of flow-metering systems

Figure 1 a) shows a system which comprises a vertical measuring tube whose cross-section increases upwardsand in which a float is lifted by the action of the gas flow. The float settles at a height which is a function of theflowrate, 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 afixed orifice. The paddle is pushed by the action of the gas flow and settles at a position which is a function of theflowrate, 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 pressuregauge. 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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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

Key d) Flow-metering device with a hose and a DISS or NIST nut and nipple as inlet connector

1 Flow control valve 2 Inlet connector 3 Outlet connector 4 Measuring tube 5 Hose

Figure 2 — Typical examples of flow-metering devices




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5 General requirements

5.1 Safety

Flow-metering devices shall, when transported, stored, installed, operated in normal use and maintained according tothe instructions of the manufacturer, cause no safety hazard which could be foreseen, using risk analysisprocedures in accordance with ISO 14971, which is connected with their intended application, in normal conditionand in single fault condition.

5.2 R Alternative construction

Flow-metering devices and components or parts thereof, using materials or having forms of construction differentfrom those detailed in clause 5 of this International Standard (except for dimensions and allocation of DISS andNIST connectors and probes used as inlet connectors) shall be accepted if it can be demonstrated that anequivalent 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 burnviolently 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 ata valve seat or by adiabatic compression produced when oxygen at high pressure is rapidly introduced into a system initially atlow pressure.

NOTE 2 Compatibility with oxygen includes resistance to corrosion from moisture and surrounding materials.

NOTE 3 ISO 15001 deals with the compatibility of medical equipment with oxygen.

5.3.2 The materials shall permit the flow-metering device and its components to meet the requirements of 5.4(except 5.4.6) in the temperature range of 20 °C to + 60 °C.

5.3.3 Flow-metering devices shall meet the requirements of 5.4 after being exposed, while packed for transport and storage, to environmental conditions as specified by the manufacturer.

5.3.4 Springs, highly strained components and parts liable to wear which come in contact with the medical gas shall not be plated.

NOTE Plating could come off.

5.3.5 R Evidence of conformity with the requirements of 5.3.1, 5.3.2, 5.3.3 and 5.3.4 shall be provided by the manufacturer.

5.4 Design requirements

5.4.1 Inlet connector

5.4.1.1 The inlet connector shall be one of the following:

a) a probe complying with ISO 9170-1 [see Figure 2 a)]

b) a DISS or NIST nut and nipple complying with ISO 5359 [see Figure 2 b)];




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c) an assembly consisting of a hose insert, a length of hose and a probe complying with ISO 9170-1[see Figure 2 c)];

d) an assembly consisting of a hose insert, a length of hose and a DISS or NIST nut and nipple complying withISO 5359 [see Figure 2 d)].

5.4.1.2 These assemblies shall comply with ISO 5359 except that the outlet connector is replaced by an outlet connector complying with 5.4.2 a).

Compliance shall be checked by visual inspection.

5.4.2 Outlet connector

The outlet connector shall be one of the following:

a) a permanently connected hose insert;

b) a proprietary fitting, with or without a hose insert.

Compliance shall be checked by visual inspection.

5.4.3 R Filtration

A filter shall be provided which:

a) is located upstream of the flow-metering device;

b) is replaceable;

c) has openings not exceeding 100 m or equivalent mesh.

Evidence shall be provided by the manufacturer.

5.4.4 Scales and indicators

5.4.4.1 All flow-metering devices shall be graduated in units of litres per minute (l/min).

NOTE For flowrates of less than 1 l/min, the flow-metering devices may be graduated in millilitres per minute (ml/min).

5.4.4.2 Unit graduations in flow-metering device scale increments shall be not less than the stated accuracy at agiven flowrate, or not less than 1 l/min for flowrates greater than 10 l/min.

5.4.4.3 The indicator of a flow-metering device shall be visible to the user at all flowrates, including zero flow.

5.4.4.4 The scale of the flow-metering device shall be legible to an operator having a visual acuity (corrected ifnecessary) of one, sitting or standing 1 m from the flow-metering device at a light level of 215 lx and viewing theflowmeter perpendicular and including 90° above, below, left of and right of the operator’s direct line of vision.

5.4.4.5 Compliance with the requirements of 5.4.4.1 to 5.4.4.4 shall be checked by visual inspection.

5.4.5 Mechanical strength

The flow-metering device shall meet the requirements of 5.4 after containing for 10 min or relieving a pressure of1 000 kPa.

The test for mechanical strength is given in 6.2.




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5.4.6 Accuracy of flowrate

The flowrate at any graduation of a flow-metering device shall be within ±10 % of the indicated value for flowratesbetween 10 % and 100 % of full scale or ±0,5 l/min, whichever is greater. For flowrates below 10 % of full scale,the accuracy shall be disclosed by the manufacturer.

For flow-metering devices for measuring flowrates less than or equal to 1 l/min, the accuracy of the flowrate at any flowrate graduation shall be within ±10 % of the full scale.

The accuracy shall be measured throughout the range of inlet pressures specified by the manufacturer, when the flow is discharged into ambient atmosphere, after the test for mechanical strength has been carried out.

The test for accuracy of flowrate is given in 6.3.

To enhance accuracy and to reduce the hazard of static discharge, means should be provided to minimize the build-up of electrostatic charges, both inside and outside the flowmeter tube and its housing.

5.4.7 Flow control valve

5.4.7.1 The control knob and the valve spindle shall be designed such that they cannot be disengaged without the use of a tool.

The flow control valve should be designed so that the flowrate increases when the knob is turned counter- clockwise.

5.4.7.2 Compliance with the requirements of 5.4.7.1 shall be checked by visual inspection.

5.4.8 Leakage

The total internal leakage with the flow control valve closed with a torque of 0,4 N·m shall not exceed 0,3 ml/min(0,030 3 kPa·l/min) at p1, after the tests for mechanical strength and accuracy have been carried out.

The total external leakage (to the atmosphere) shall not exceed 0,5 ml/min (0,050 6 kPa·l/min) at p1 after the tests for mechanical strength and accuracy have been carried out.

The test for leakage is given in 6.4.

5.4.9 R Resistance to ignition

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 not be lower than 160 °C.

Evidence of conformity with this requirement shall be provided by the manufacturer.

The determination of the autoignition temperature shall be carried out in accordance with ISO 11114-3.

NOTE The maximum permitted operating temperature of tested material is 100 °C lower than the autoignition temperatureat the corresponding oxygen pressure. This safety margin is necessary because it covers both an unforeseen increase in theoperating temperature and the fact that the autoignition temperature is not a constant. Values of the autoignition temperaturealways depend on the test method used, which does not exactly simulate all possible operating conditions.

5.4.10 Connection to rail systems

If a flow-metering device fitted with an inlet connector complying with 5.4.1.1 c) or d) is intended to be supported by arail system complying with EN 12218, it shall be provided with one of the following devices complying with EN12218:

a rail clamp;

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an equipment mount;

an equipment mount pin.

5.5 Constructional requirements

5.5.1 R Cleaning

The components of flow-metering devices for all gases shall be supplied clean and free from oil, grease and particulate matter.


NOTE 1 Any method of cleaning and degreasing which effectively removes all surface dirt and hydrocarbons, and whichleaves no residue itself, may be used. Chemical cleaning methods will normally require subsequent washing and dryingprocesses to remove residues.

NOTE 2 Examples of cleaning procedures are described in ISO 15001.

5.5.2 R Lubricants

If lubricants are used, they shall be compatible with oxygen, the other medical gases and their mixtures in the temperature range specified in 5.3.2 up to the test pressure of 1 000 kPa.


5.5.3 Loosening torque

The torque required to remove the inlet connector from the flow-metering device shall be greater than or equal to12 N m.

The test for loosening torques is given in 6.5.

5.5.4 Flow-setting torque

If there are multiple fixed orifices, the torque required to change from the “off” position and from one setting to another shall be not less than 0,5 N·m and the control shall self-centre at each setting.

The test for operating torques is given in 6.5.

5.5.5 R Inadvertent disassembly

Means shall be provided to prevent inadvertent disassembly of the flow-metering device.


6 Test methods

6.1 General

6.1.1 Ambient conditions

Except where otherwise stated, tests shall be carried out at 23 °C ± 2 °C.




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6.1.2 Test gases

Except where otherwise specified, tests shall be carried out with clean, oil-free dry air, nitrogen or the specific gaswith a maximum moisture content of 50 µg/g (50 ppm) corresponding to a dew point of -48 °C at atmosphericpressure.

6.1.3 Reference conditions

Flowrates shall be corrected to 23 °C and 101,3 kPa.

If a flow-metering device is tested with a gas other than the specific gas, flowrates shall be converted.

Conversion coefficients are given in Table 1, where flowrate of intended gas = flowrate of test gas conversion coefficient.

Table 1 — Conversion coefficients

Test gas Conversion coefficient for

Air Oxygen N2O CO2 Helium Xenon

Air 1 0,95 0,81 0,81 2,69 0,47 Nitrogen 0,98 0,93 0,79 0,79 2,65 0,46

6.2 Test method for mechanical strength

Compliance shall be determined by following the procedure below:

a) seal or plug the flow-metering device outlet;

b) open the flow control valve;

c) subject the flow-metering device to a test pressure of 1 000 kPa;

d) verify that the flow-metering device is capable of containing for 10 min or safely relieving the test pressure;

e) return the flow-metering device to p1 and carry out the tests for accuracy and leakage given in 6.3 and 6.4.

6.3 Test method for accuracy of flowrate

Test the accuracy of flowrate, using the equipment shown in Figure 3, after the test for mechanical strength has been carried out.

This test shall be carried out at the maximum and minimum inlet pressures specified by the manufacturer.




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Key 1 Gas supply 2 Pressure regulator 3 Calibrated gauge 4 Test sample with flow control valve 5 Thermometer 6 Calibrated flowmeter

Figure 3 — Equipment for testing accuracy of flowrate

6.4 Test method for leakage

6.4.1 Internal leakage

The device shall be tested with gas at p1 supplied to the inlet connector with the flow control valve closed with a torque of 0,4 N·m after the tests for mechanical strength and accuracy have been carried out.

6.4.2 External leakage

The device shall be tested with gas at p1 supplied to the inlet connector, with the flow control valve open and the outlet sealed or plugged after the tests for mechanical strength and accuracy have been carried out.

6.5 Test method for loosening and operating torques

Measure the torques using an appropriate torque spanner.

Check that multiple orifices self-centre by visual inspection.

6.6 Test method for durability of markings and colour coding

Rub markings and colour by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water,then for 15 s with a cloth rag soaked with ethanol and then for 15 s with a cloth rag soaked with isopropanol. Carryout this test at ambient temperature.

Check for durability by visual inspection.




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7 Marking, colour coding and packaging

7.1 Marking

7.1.1 Flow-metering devices and their gas-specific components shall be durably and legibly marked with thesymbol of the relevant gas in accordance with Table 2. In addition to the symbol, the name of the gas may be used.The test for durability of markings is given in 6.6.

In addition, flow-metering devices shall be marked with the following:

the name and/or the trademark of the manufacturer or distributor;

means to ensure traceability, such as type, batch or serial number or year of manufacture;

the rated inlet pressure p1;

point of reference for reading the flow-indicating element;

the range of inlet pressure for which the flow-metering device is calibrated;

"USE NO OIL" or the symbol shown in Figure 4.

NOTE The words "USE NO OIL" may be expressed in the relevant national languages.

Figure 4 — Symbol for “USE NO OIL”

Table 2 — Medical gases, marking and colour coding

Name Symbol Colour codinga

Oxygen O2 White Nitrous oxide N2O Blue

Air for breathing Air Black-White

Helium He Brown

Carbon dioxide CO2 Grey Xenon Xe Light brownb

Mixtures of the above gases c c a In accordance with ISO 32. b An example of light brown is NCS 3030-Y30R as given in SS 01 91 02. c In accordance with the mixture components. NOTE The word "Air" may be expressed in the relevant national languages.

7.1.2 Flow control valves shall be clearly and durably marked with the direction for increasing flowrate.




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7.1.3 Compliance with 7.1.1 and 7.1.2 shall be checked by visual inspection.

7.2 Colour coding

7.2.1 If colour coding is used, it shall comply with ISO 32 (see Table 2) or relevant national standards.

7.2.2 Compliance shall be checked by visual inspection.

7.2.3 Colour coding shall be durable.

7.2.4 The test for durability of colour coding is given in 6.6.

7.3 Packaging

7.3.1 Flow-metering devices and spare parts shall be sealed to protect against particulate contamination and packaged to prevent damage during storage and transportation.

7.3.2 Packages shall provide a means of identification of the contents.

7.3.3 Compliance shall be checked by visual inspection.

8 Information to be supplied by the manufacturer

8.1 Flow-metering devices shall be accompanied by documents containing at least a technical description,instructions for use and an address to which the user can refer. The accompanying documents shall be regardedas a component part of flow-metering devices.

8.2 Instructions for use shall contain all information necessary to operate the flow-metering device in accordancewith its specifications and shall include explanation of the function of controls, connection and disconnection ofdetachable parts and accessories. Instructions for use shall include indications on recognized accessories anddetachable parts if the use of other accessories and parts can degrade the minimum safety. Instructions for useshall give detailed instructions for the safe performance of cleaning, inspection and preventive maintenance to beperformed by the operator or by authorized persons, and shall indicate the frequency of such activities. A list ofrecommended spare parts shall be provided. The meaning of figures, symbols, warning statements andabbreviations on the flow-metering device shall be explained in the instructions for use.

NOTE Examples of symbols to be used with medical devices are given in ISO/TR 15223.

8.3 Particular attention shall be given to the following safety-related items:

the danger of fire or explosion arising from use of lubricants not recommended by the manufacturer;

the danger of changing the connectors on flow-metering devices;

the danger of disassembling the flow-metering device while under pressure;

the effect on the accuracy of flowrate which may result from varying inlet pressure;

the effect on the accuracy of flowrate which may result from varying outlet resistance;

the effect on the accuracy of flowrate due to variations in ambient temperature from 0 °C to + 40 °C.




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Annex A(informative)

Rationale

The following paragraphs provide the rationale for certain text in the body of this International Standard. The numbering therefore is not consecutive.

5.2 Evidence will be provided to e.g. a Notified Body during conformity assessment and Competent Authorityupon request. Attention is drawn to ISO 14971 on risk analysis and to the International Standards underdevelopment by ISO/TC 210 on risk evaluation and risk control.

5.3.5 Evidence of such compatibility will be provided e.g. to a Notified Body during conformity assessment andCompetent Authority upon request.

5.4.3 Evidence will be provided e.g. to a Notified Body during conformity assessment and Competent Authority upon request.

5.4.9 Flow-metering devices for different gases are often made with interchangeable components or sub-assemblies. The requirement for the ignition temperature of non-metallic components should therefore be applied toflow-metering devices for all gases.

Evidence of compliance with the requirement that the non-metallic materials used have ignition temperature above160 °C will be provided e.g. to a Notified Body during conformity assessment and Competent Authority upon request.

5.5.1 Flow-metering devices for different gases are often made with interchangeable components or sub- assemblies. The requirement for cleaning should therefore be applied to flow-metering devices for all gases.

Evidence of such compatibility will be provided e.g. to a Notified Body during conformity assessment andCompetent Authority upon request.






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Bibliography

[1] ISO 4135, Anaesthetic and respiratory equipment — Vocabulary.

[2] ISO 7396-1, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum.

[3] ISO 10524, Pressure regulators and pressure regulators with flow-metering devices for medical gas systems.

[4] ISO 15001, Anaesthetic and respiratory equipment — Compatibility with oxygen.

[5] ISO/TR 15223:1998, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied.

[6] EN 739, Low-pressure hose assemblies for use with medical gases.

[7] SS 01 91 02, Colour Atlas.




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Approved as an American National Standard with deviation by ASTM International

ANS/ISO 15002:2000(E)

ICS 11.040.10 Price based on 15 pages

© ASTM International – All rights reserved




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Approved as an American National Standard with deviations by ASTM International


ASTM Deviations to ISO 15002: 2000 Clause 2 - Normative references Delete the following: ISO 32, Gas cylinders for medical use – Marking for identification of content. ISO 5359, Low-pressure hose assemblies for use with medical gases. Add the following: CGA C-9:1993, Standard color marking of compressed gas containers intended for medical use. ASTM/ISO 5359:2003, Low-pressure hose assemblies for use with medical gases. CGA V-5:2000, Diameter Index Safety System (noninterchangeable low pressure connections for medical gas applications). Rationale for ASTM deviations: CGA C-9 establishes the medical gas color code used in the United States, which is different from the medical gas color code established by ISO 32. ASTM/ISO 5359:2003 is the recent adoption by ASTM of the most current edition of ISO 5359. The ASTM adoption of ISO 5359 includes deviations to reflect the requirements of low-pressure hose assemblies for use with medical gases in the United States. CGA V-5 contains the dimensions for the diameter index safety system connectors




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5.3 Materials Delete the following text: 5.3.2 The materials shall permit the flow-metering device and its components to meet the requirements of 5.4 (except 5.4.6) in the temperature range of -20 °C to + 60 °C. Add the following text: 5.3.2 The materials shall permit the flow-metering device and its components to meet the requirements of 5.4 (except 5.4.6) when operated in the temperature range of -20 °C to + 50 °C. Rationale for ASTM deviation: The deviation was necessary to clarify that 5.3.2 applies to operating temperature, and to reduce the operating temperature range to more closely match CGA E-7. Delete the following text: 5.3.3 Flow-metering devices shall meet the requirements of 5.4 after being exposed, while packed for transport and storage, to environmental conditions as specified by the manufacturer. Add the following text: 5.3.3 Flow-metering devices shall meet the requirements of 5.4 after being exposed, while packed for transport and storage, to temperatures of -40oC and +60oC, unless otherwise specified by the manufacturer.

Rationale for ASTM deviation: This deviation was necessary to make it correspond to other ASTM and ISO standards.




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5.4.1 Inlet connector Delete the following: 5.4.1.1 b) a DISS or NIST nut and nipple complying with ISO 5359 [see Figure 2b)]; 5.4.1.1 d) an assembly consisting of a hose insert, a length of hose and a DISS or NIST nut and nipple complying with ISO 5359 [see Figure 2d]]; Add the following: 5.4.1.1 b) a DISS nut and nipple complying with ASTM/ISO 5359 [see Figure 2b)]; 5.4.1.1 d) an assembly consisting of a hose insert, a length of hose and a DISS nut and nipple complying with ASTM/ISO 5359 [see Figure 2d]]; Rationale for ASTM deviation: NIST connectors are not used in the United States. The reference to ISO 5359 needed to be replaced with ASTM/ISO 5359. 5.4 Design requirements Delete the following: 5.4.1.2 These assemblies shall comply with ISO 5359 except that the outlet connector is replaced by an outlet connector complying with 5.4.2 a). Add the following: 5.4.1.2 These assemblies shall comply with ASTM/ISO 5359 except that the outlet connector is replaced by an outlet connector complying with 5.4.2 a). Rationale for ASTM deviation: Replace the reference to ISO 5359 with ASTM/ISO 5359.




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5.4.4 Scales and indicators Delete the following: 5.4.4.4 The scale of the flow-metering device shall be legible to an operator having a visual acuity (corrected if necessary) of one, sitting or standing 1 m from the flow-metering device at a light level of 215 lx and viewing the flowmeter perpendicular and including 90° above, below, left of and right of the operator’s direct line of vision. Add the following: 5.4.4.4 The scale of the flow-metering device shall be legible to an operator having a visual acuity (corrected if necessary) of one, sitting or standing 1 m from the flow-metering device at a light level of 215 lx and viewing the flowmeter perpendicular and including 15° above, below, left of and right of the operator’s direct line of vision. Rationale for ASTM deviation: The deviation was necessary since viewing the indicators 90° above below, left and right of the operator’s line of sight was not consistent with other standards that define legibility using 15° above, below, left of and right of the operator’s line of sight. 5.4.5 Mechanical strength Delete the following text: The flow-metering device shall meet the requirements of 5.4 after containing for 10 min or relieving a pressure of 1 000 kPa. Add the following text: The flow-metering device shall meet the requirements of 5.4.6 (accuracy) and 5.4.8 (leakage) after containing for 10 min or relieving a pressure of 1 000 kPa. Rationale for ASTM deviation: The reference in the ISO text to 5.4 is too vague. The test method [6.2.c)] mentions only tests for accuracy and leakage after applying the 1000 kPa.




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5.4.6 Accuracy of flowrate Delete the following text: The flowrate at any graduation of a flow-metering device shall be within 10 % of the indicated value for flowrates between 10 % and 100 % of full scale or 0,5 l/min, whichever is greater. For flowrates below 10 % of full scale, the accuracy shall be disclosed by the manufacturer. For flow-metering devices for measuring flowrates less than or equal to 1 l/min, the accuracy of the flowrate at any flowrate graduation shall be within ±10 % of the full scale. The accuracy shall be measured throughout the range of inlet pressures specified by the manufacturer when the flow is discharged into ambient atmosphere, after the test for mechanical strength has been carried out. Add the following text: For a flow-metering device with a full scale greater than 1 l/min the flowrate at any graduation shall be within 10 % of the indicated value for flowrates between 10 % and 100 % of full scale or ±0,5 l/min, whichever is greater. For flowrates below 10 % of full scale, the accuracy shall be disclosed by the manufacturer. For a flow-metering device with a full scale less than or equal to 1 l/min, the accuracy of the flowrate shall be disclosed by the manufacturer. The accuracy shall be measured at the inlet pressure specified by the manufacturer when the flow is discharged into an atmosphere 101, 3 kPa and 21 C ±2° C, after the test for mechanical strength has been carried out. Rationale for ASTM deviations: The changes in accuracy requirements were necessary to make clear that the accuracy in the first paragraph applied only to flow-metering devices with a full scale over 1 l/min. The change in measuring the accuracy was made because flow-metering devices are usually only calibrated at one inlet pressure.




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5.4.7 Flow control valve Delete the following: 5.4.7.1 The control knob and valve spindle shall be designed such that they cannot be disengaged without the use of a tool Add the following: 5.4.7.1 The control valve assembly shall be designed such that it cannot be removed when an axial force of 100 N is applied for 1 min. The control knob shall not rotate with respect to the valve spindle when a torque of 1 Nm is applied for not less than 2 s in each direction alternatively. The test shall be repeated 10 times. NOTE These requirements were taken from IEC 60601-1:1988 NOTE On a flow-metering device with multiple fixed orifices, it is recommended that the device be designed to self-center on a flow setting and to prevent selection of positions where there is no flow (e.g. between fixed settings) except for the zero flow setting. Rationale for ASTM deviations: Requiring a tool for disengagement was felt to be design-restrictive. The second note was added to call attention to the danger of using a device where there is no flow between fixed settings. See reference added to bibliography. 6.1.1 Ambient conditions Delete the following: Except where otherwise stated, tests shall be carried out at 23 °C ±2 °C. Add the following: Except where otherwise stated, tests shall be carried out at 21 °C ±2 °C. Rationale for ASTM deviation: 21o C is the temperature used in most ISO and ASTM documents and is industry practice.




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6.1.3 Reference conditions Delete the following: Flowrates shall be corrected to 23 °C ±2 °C and 101,3 kPa. Add the following: Flowrates shall be corrected to 21 °C ±2 °C and 101,3 kPa. Rationale for ASTM deviation: 21o C is the temperature used in most ISO and ASTM documents and is industry practice. 6.3 Test method for accuracy of flowrate Delete the following: This test shall be carried out at the maximum and minimum inlet pressures specified by the manufacturer. Add the following text: This test shall be carried out at the inlet pressure specified by the manufacturer. Rationale for ASTM deviation: Flow rates are usually calibrated at only one pressure. 7.1 Marking Delete the following: - the range of inlet pressure for which the flow-metering device is calibrated. Add the following: - the inlet pressure for which the flow-metering device is calibrated. Rationale for ASTM deviation: Flow rates are usually calibrated at only one pressure.




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Table 2 – Medical gases, marking and colour coding Delete the existing table and replace with the following:

Table 2 – Medical gases, marking and colour coding

Name

Symbol Colour codinga

Oxygen

O2 Green

Nitrous oxide

N2O Blue

Air for breathing

Air Yellow

Helium

He Brown

Carbon dioxide

CO2 Grey

Xenon

Xe Light brownb

Mixtures of the above gases

C C

a In accordance with CGA C-9. b An example of light brown is NCS 3030-Y30R as given in SS 01 91 02. c In accordance with the mixture components. Rationale for ASTM Deviation: CGA C-9 establishes the medical gas color code used in the United States, which is different from the medical gas color code established by ISO 32. 7.2.1 Colour coding Delete the following: If colour coding is used, it shall comply with ISO 32 (see Table 2) or relevant national standards. Add the following: If colour coding is used, it shall comply with CGA C-9 (see Table 2). Rationale for ASTM deviations: CGA C-9 establishes the medical gas color code used in the United States, which is different from the medical gas color code established by ISO 32.




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8 Information to be supplied by the manufacturer Add the following text to 8.3: - for flow-metering devices with multiple fixed orifices, a warning to the effect that there might be no gas flow between flow settings. Rationale for ASTM deviation: This was added to call attention to the danger of using a device where there is no flow between fixed settings. See reference 8 added to the Bibliography. Bibliography Add the following: [8] Adekayne O, Wali AR. Oxygen delivery failure. Anaesthesia 2003; 58: 190-1. Rationale for ASTM deviation: This contains a description of the hazard addressed by the second NOTE added to 5.4.7.1 and the text added to 8.3. .




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Documents

ANS ISO 15002