Bsi bs en 13220 1999 scan

BRITISH STANDARD Flow-metering devices for connection to terminal units of medical gas pipeline systems The European Standard EN 13220:1998 has the status of a British Standard res 11

BRITISH STANDARD

Flow-metering devices for

connection to terminal units of

medical gas pipeline systems

The European Standard EN 13220:1998 has the status of a

British Standard

res 11.040.10; 17.120.10

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHr LAW

BSEN

13220:1999

BS EN 13220:1999

This British Standard, having

been prepared under the

direction of the Health and

Envirorunent Sector Committee,

was published under the

authorily of the Standards

Committee and comes into effect

on 15 April 1999

© BS( 04·1999

ISBN 0580 30686 0

National foreword

This British Standard is the English JanllPJal~e version of EN 13220: 1998

The UK participation in its preparation was entrusted by Technical Conunittee

CHl44, Anaesthetic machines, breathing ati:aclunents, medical gas systems

- aid enquirers to understand the pre~eJlt to the responsible committee any enquiries on the interpretation, or proposals for change, and the UK interests infonned.;

- 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 secretaIy

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 "International Standards Correspondence Index", or by the

"Find~ of the BSI Standards Electronic Catalogue

A British Standard does not purport to include all the necessary of a contract Users of British Standards are responsible for their correct application

COlm))lliLn(:e with a British Standard does not of itself confer fmm unity

obligations

Summary of pages

This document comprises a front cover, an inside front cover, the EN title page, pages 2 to an inside back cover and a back cover

Amendments issued since publication

EUROPEAN STANDARD

NORME EURopEENNE

EUROPAIscHE NORM

ICS 11.040.10; 17.120.10

EN October 1998

Descriptors: medical equipment, anaesthetic equipment, artificial breathing apparatus, junctions, gas pipelines, medical gases,

flow measurements, measuring instruments, defirutions

DisJXJS,itifs a debilmetre

murales Durch:flu&neBeiruichtungen zum Anschl1 1S an

Entnahmestellen von Rohrleitungssytemen fUr medizinil§che Gase

CEN members are bound to comply with the CEN/CENELEC Internal Re~~tiOI'IS which stipulate the conditions for giving this Standard the status of a national standard without any alteration lists and

references such national standards may be obtained on application to

This StandaId exists in one official vemion in accordance with Resolution

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

United Kingdom

CEN European Committee for Standardization Comit.e Europeen de Normalisation Europaisches Komitee ffir N,.",rnnln<r

Central Secretariat: rue de Stassart 8-1050 Brussels

©1998 CEN All rights of eXl)loiltatiion in any fonn and by allY means reserved worldwide for CEN national Members

Ref No EN 13220: 1998 E

Page 2

Foreword

This European Standard has been by

anaesthetic the Secretariat of which is held

by BSI

This European Standard shall be the status of a

text or by endorsement, at the latest Aprillggg, and

conflicting national standards shall be withdrawn at

the latest by April 1999

This European Standard has been under a

mandate given to by the European CoJrnIllLission

supports essential requirements of EU llWective(s)

For relationship with ED Directive(s), see informative

annex ZA, which is an integrnl part of this standard

For special national conditions for 5.4.1, 7.2.1

and Thble 2, see annex D

Annex D forms a normative part of this I!:W:'ODIOOII

Standard Annexes C and ZA are given for

information only

According to the CENICENELEC Internal Re~DllatiOIIS,

the national standards organizations of the UJJJll,nllU':

countries are bound to implement this "~n'il)')j_n

Standard: Austria, Belgiwn, Czech Republic,

France, Germany, Greece, Iceland, Ireland,

Luxembourg, Netherlands, Norway, Portug:ll,

Sweden, Switzerland and the United KiJ1tgctl)m

Contents

Foreword Introduction

I

2 Normative references

3 Definitions

4

5 General requirements

6 Thst methods

8 Information to be supplied manufacturer

Annex A (informative) 1YPical of flow-metering systems

Annex B (informative) Bib,lioJuaJJQV Annex C (in1foffllatilve) Rationale Annex D (normative) Special national conditions Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives

2

3

3

3

3

4

4

6

7

8

12

15

15

15

16

BSI 04-1999

Introduction

J:<'low-rne1JeruljO{ devices are widely used in the delivery

of medical gases supplied by a medical gas supply

system to a patient It is essential that these

devices deliver accurate flows under varying conditions

of temperature and inlet It is therefore

irnllOrtant that the characteristics be

This standard pays particular attention to:

sui1tability of materials;

(mechanical safe relief of excess

pressure and resistance to ignition);

- gas specificity;

- cleanliness;

-accuracy;

rruorrnationsupplied

Clauses and subclauses marked with B after their

in annexC

1 Scope

1.1 This European Standard applies to:

- flow-metering devices which are connected and

disconnected the operator at tenninal units of a

medical pipeline system for measurement and

medical gases; they can be connected

or by means of flexible 'n"'''ti.'C1

- flow-metering devices which are connected and

disconnected the operator at ~asesPleciflc

regulators

no'/V-nleUenfll! devices for the oxygen;

- nitrous oxide;

- air for breathing;

- carbon dioxide;

xenon;

specified mixtures of the gases listed

O]GrgeJVnlUOIlS oxide mixture (50 %/ 50 % VIV)

1.3 Electrical or electronic flow-metering devices are

excluded from the scope of this standard

© SST 04-1999

2 Nonnative references

Page 3

EN 13220:1998

undated reference, provisions from publications These normative references are cited at the

appropriate in the text and the publications are listed hereafter For dated subsequent anlendrnents to or revision of any of these apply to this European Standard onlY when inc1orpora.ted in it by anlendrnent or revision For undated references, the latest edition of the publication referred to atJIJU""'

campressed medical gases and VllC'Uum

ES 739, Low-pressure hose assemblies for use with

medical gases

EN 1441, Meaic.al devices - Risk (rm111J"~i_~

E~ 12218, Rail systems for su.pporting medical equipment

identification of content

3 Definitions

nu."""" " of this European Standard the defiinitions apply

flow gauge

gauge which measures pressure differential and which

is calibrated in units of flow NOTE The flow

upstream of a 3.2

flowmeter

indicates flow by measuring the pressure

device that measures and indicates the flow of a specific gas

3.3

n(1.w-m'\".4li1l'l~Ul device

device fitted with an inlet and an outlet connector and which incOlporates one of the following:

a) a flowmeter and a flow control b) a flow and a fixed orifice with a flow control

mUttlplC fixed orifices with a means of sel;ectIDg

3.4

gas-specific

having characteristics which prevent interchangeability and allow assignment to one gas or vacuum service only

4

EN 18220:1998

3.5

flWiI-sDe,clric connection point

that part of the socket which is the receptor for a

3.6

medical gas

any gas or mixture of gases intended to be

administered to patients for therapeutic, diagnostic or

prophylactic pruposes, or for surgical tool 3pI)llca:ticlR

3.7

medical gas pll)elltne

pipeline disltriblllti(J.n and terminal units at the

points where medical gases or anaesthetic gas

~:we'ruIime: can be n:><n11.C'f>l'I

3.8

medical gu supply ",i-

either:

a) a medical gas system; or

b) any other installation having no permanent

pipeline system but employing a medical gas supply

3.9

NIST connectors

non-interchangeable screw-threaded connectors

different a left or right-hand screw

gas

3.10

probe

non-interchangeable male component designed for

acceptance by and retention in the socket

3.11

rated inlet pressure,

rated maximum u~mam pressure for which the

3.12

single-fault condition

a hazard in is aelet-"tlVe or a single

external abnonnal condition is ~~£"'£""

3.13

socket

that part of a terminal unit which is either int.,,-.,,[ or

3.14

terminal unit

outlet assembly (inlet for vacUUI10) in a medical gas

connections and disconnections NOTE Terminal units and gas-specific connection points can also

be connected to pressure regulators or low-pressure hose

assemblies

4 Thrminology Typical examples of tlo'w-llnetJeliIU!: S1llStE~~'l are shown

in annexA

5 General requirements

5.1 Safety

.t.U~l<U.I,t:u, operated in normal use according to the instructions of the manUltact;un~, cause no safety hazard which could be foreseen using

risk procedures in accordance with EN 1441 and which is connected with their intended in

nonnal condition and in single-fault condition

5.2R Alternative construction

t+lOtw-:meterinj."{ devices and or

materials or having forms of

.l!iUrDJJean Standard (except for dimensions and allocation of connectors and probes used as inlet c01IDe:ctclm) shall be accepted if it can be

demonstrated that an equivalent degree of is

obtained

Such evidence shall be provided by the manufacturer

See annex D for special national conditions

5.3 Materials

5.3.1 The materials in contact with the shall be

cOl1np:JltibJle with oxygen, and with the medical gases and their in the teIlnPE!rature range specified in 5.3.2

NOTE 1 Corrosion resistance includes resistance against moisture and surrolmding materials

NOTE 2 with oxygen involves both combustibility and ease of which burn in air will burn violently

in pure oxygen Many materials which do not burn In air will do

so in pure under pressurR Similarly, materials which can in air require lower ignition energies in

oxygen materials can be ignited by friction at a valve

pressure is rapidly Into a system initially at low pressure

NOTE 3 13159 GompatWitity of medical equipment u>i.th

5.3.2 The m.ateri.als shall pemrit the flow-metering

of -20

© BSI 04-1999

5.3.3 Flow-metering devices shall be capable, while

environmental conditions as stated by the

manufacturer

5.8.4 Springs, highly-strained components and

liable to wear, which corne into contact with .>' 1

gases, shall not be plated

NOTE Plating could come off

5.3.5R Evidence of coruol:mity with the

of is.3.2, is.3.3 and 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:

comp1ying with

A2a);

737-6:1996

b) a NIST nut and nipple complying with EN 739

A2b);

c) an consisting of a hose insert, a length

of hose and a probe complying with prEN 737.0:1996

FIgure A2c);

d) an assembly consisting of a hose insert, a length

of hose and a NIST nut and complying

with EN 739 Figure

5.4.1.2 These assemblies shall comply with EN 739,

except that the outlet connector is replaced by the

hose insert specified in EN 739

See annex D for special national conditions

COlnpUian<:e shall be checked 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

is.4.3R Filtration

A filter shall be provided which:

a) is located of the now-metering device;

b) is reptac~~aI)le;

c) has not exceeding 100 IJ.IIl or equivalent

mesh

Evidence shall be provided by the manufacturer

5.4.4 Scales and indicators

5.4.4.1 All tlmv-metel:1ng

units of litres per minute

NOTE For flows of less than lllrnin the flow-metering devices

can be graduated in millUitres per minute (mI/min)

5.4.4.2 Unit graduations in flow-metering device scale

increments shall be not less than the stated accuracy

at a given flow

Page 5

13220:1998

5.4.4.3 The indicator of a flow-metering device shall

be visible to the user at all now rates, including zero flow

5.4.4.4 The scale of the now-metering device shall be

necessary, of 1, or standing 1 m the

at an illuminance of215lx 5.4.4.5 Compliance with the requirements of 5.4.4.1

to is.4.4.4 is checked by visual inspection

5.4.5 Meclumical strength

The no'w-nleOenrlg containing for 10

of 1 OOOkPa

C8J)ab.le of either HO"'''''''U'', a pressure The test for mechanical strength is given in 6.2

The accuracy of the flow at any flow graduation of a

flow-metering device shaH be within flO % of the indicated value for flows between 10% and 100% of

full scale or ±o,5 whichever is For flows below 10 % of full the accuracy be disclosed the manufacturer

For flow-metering devices for measuring flows less

than or equal to ll/min, the accuracy of the flow at

any flow graduation shall be within ilO % of the full

scale

The accuracy shall be measured throughout the range

of inlet pressure by the manufacturer; when the flow is discharged into ambient atmosphere, after the test for mechanical has been carned out The test for accuracy of flow is given in 6.3

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

5.4.7 Flow control "aive

5.4.7.1 The control knob and the valve

be designed so that cannot be ruseng:ag~~ the use of a tool

The flow control valve shall be designed so that the flow increases when the knob is turned

counter-clockwise

5.4.7.2 Compliance with the requirements of5.4.7.1 shall be checked by visual IIlSpe(:tion

5.4.8 Leakage

The total internal with the flow control valve closed with a torque N·m, shall not exceed 0,3 ml/min (0,030 3 at after the tests for mechanical strength and accuracy have been carned out

The total external leakage (to the atmosphere) shall not exceed 0,5 mllmin (0,0506 kPa·llmin) at after tlle tests for mechanical and accuracy have been earned out

The test for leakage is in 6.4

Page 6

EN 13220:1998

5.4.9B Resistance to ignition

For flow-metering devices for all gases, the

components in contact with the gas, including the

sealing materials and lubricants (if used), shall not be

lower than 160 °e

Evidence of with tllis requirement shall be

provided by the manufacturer

The test for the detennination of the auto-il!nitlon

temperature is in 6.5

oennitb!d operating temperature of tested material

safety margin is np'c:'~!il.C;;aTV because it covers an unforeseen increase of the "neraUl""

temperature and the fact that the auto-ignition temperature not

a constant In this connection, it should be emphasized that values

of the auto-ignition always depend on l.he lest method

used, which does not simulate all possible operating

conditions

5.4.10 Connection to rail systems

If a flow-metering fitted with an inlet connector

complying with 5.f.l.lc or 5.4.1.1d, is intended to be

"" ,.nn,r-t.oorl by a rail complying with EN it

shalJ be provided with one of the following devices

comp)ying with EN 12218:

a rail clamp;

- an equipment mount;

- an equipment mount pin

5.5 Constructional reqrull'emlenlts

5.5.1B Cleanlng

The components of tlow-lrneter:IIUZ devices for all

shall be supplied clean and free oil, grease

jJ ,\.-I , "" matter

Evidence shall be provided by the manufacturer

which effectively removes all surface dirt and hydrocarbons, and

which leaves no residue Itself Chemlcal cleaning methods will

normally require a subsequent washing and drying process to

remove residues

NOTE 2 of cleaning procedures will be described

13159 Clnll.patimlity 11Jith oxygen,

pre):larn.tion by

S.5.2R Lubricants

If lubricants are used, they shall be compatible with

oxygen, and with the other medical and their

m.i.xtures, in the temperature range specified in 5.3.2

up to the test pressure of 1 000 kPa

Evidence shall be provided by the manufacturer

S.5.3 Loosening torque

from flow-metering device shall be greater than or

to20N·m

The test for loosening torques is in 6.6

5.5.4 Flow setting torque

required at the maximum radil.L."i of the device

to change from the "off" position and from one setting

to another shall be not less than 5 N and not more than 50 N, and the control shall self-centre at each

setting

The test for torques is given in 6.6

5.5.liB Inadvertent disassembly

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

Evidence shall be provided by the manufacturer

6 Test methods 6.1 Gene:ml

6.1.1 Ambient conditions

where otherwise out at (23 ± 2) °e

6.1.2 'lest gas

tests shall be carried

Tests shall be carried out with clean, oil-free dry

nitrogen or the gas, with a maximum moisture content of 50 tLg/g (50 corresponding to a dew

point of -48 °e at pressure

6.1.3 R~e,.ence condition

Flows shall be corrected to 23 °e and 101,3 kPa

If a flow-metering device is tested with a gas other

than the specific gas, flows shall be converted

6.2 Test method for mechanical strength

Compliance shall be detennined by using the lU1JlUVYll''''

ordered steps:

open the flow control the flow-metering device to a test pressure

('rn1t!lilnjTI~ the pressure for at

return the flow-metering device to and carry out the tests for accuracy and lealaij~e given

in 6.3 and 6.4

6.3 Test method for accuracy of flow

Test the accuracy of flow, the shown

in 1, after the test for mechaniclll strength ha.<;

been carried out

This test shall be carried out at the maximum and

© BSI 04-1999

6.4 Test method for leakage

6.4.1 Internal leakage

The device shall be tested with pressure Pl 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 pressure to

6.7 Test method for colour coding

Page 7

EN 13220:1998

of markings and

Rub markings and colour 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 methylated and then for 15 s with a cloth

rag soaked with isopropyl alcohol Carry out this test

at ambient tenlPe~ratm:e

and the outlet sealed or plugged, after the tests for

out

6.6 Test method for determining the

auto-ignition temperature of non-metallic

materials

maJterials, including the sealing materials

as follows, using the apparatus shown in

Place finelY divided test material into a stainless-steel

tube with a chromium-nickel steel cladding, in

quantities of about to g 1b obtain large

fibrous ceramic materiaL Fill the gas-.tight tube,

containing the with oxygen at a specified

pressure (see note 2) and then inductively heat it by a

low-frequency heater in an approximately linear

manner at 120°CIrnin Monitor the temperature of the

sample as a function of time by the use of a

thermocouple, and monitor the pressure by a pressure

transducer Record both pressure and temperature by a

dual-channel recorder The point at which spontaneous

ignition occurs is denoted a sudden rise in

temperature and pressure

temperature and the COITesPOIUlliU{

pressure can be seen from

NOTE 1 Auto-ignition tenlpe~rattlIes

generally be reproduced

to 200 °C Variations of about ·C and in some cases even

higher, are known to occur in the range from 200 °C to 500 0c

Usually five tests at the same pressure are performed on each

sample

materials depend upon the test and there are differences

in the values obtained by different test The

measurement of the temperature of non-metallic

materials is typically out at a of 4 000 kPa, and

data is unavailable for a pressure of kPa The

rel~,tiOJ1Shiip is that the auto-ignition temperature non-metallic

materials with increasing oxygen pressure to an

app,roximately constant value above of 4 000 kPa It is

known that this is not followed by

"' ,'"'''''''' the properties of new non-metallic materials which

might used for oxygen service

6.6 Test method for loosening and operating

torques

Mt'asure the torques using an apjClropri:ate torque

spanner

© BSI 04-1999

7.1.1 Flow-metering devices and their gas-specific components shall be durablY and marked with the symbol of the relevant in accordance with Table 1 In addition to the the name of the gas

may be used The test for durability of is

in 6.7

The indicated value of the flow shall be legible to an

visual corrected if necessary,

1, seated or standing I m the flow-metering with an illuminance of 215 Ix

In addition, flow-metering devices and their gas-specific components shall be marked with the following:

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

or serial number or year of the rated inlet pressure, Pl;

d) point of reference for the flow-indicating

of inlet pressure for which the tlow-lne1t:eIilIlg device is calibrated;

1) the words "USE NO OIL", or the symbol shown

NOTE National Janguages can be used for "l:SE NO OIL" 7.1.2 Flow control valves shall be

marked with the direction for increasing 7.1.3 Compliance with 7.1.1 and 7.1.2 shall be checked visual insl)e<:t:io,n

7.2 Colour <.:V<L1.U1lS 7.2.1 If colour accordance with See annex D for

is used, it shall be in

l

national conditions

7.2.2 Colour coding shall be durable

The test for dw-ability of colour coding is giwn in 6.7 7.3 Packaging

sealed to protect particulate contamination and packaged to nre1ient damage during storage and transportation

7.3.2 sha1l n "nl'IP a means of identification

of the contents

PageS

EN 13220:1998

Table 1 Medical gases, mArkina and colonl'

Nitrous oxide

Carbon dioxide

Mixtures of the above gases 3)

l) According to ISO 32

2) An example of light brown is NCS 303O-Y30R in SS 0191 02

3) According to the components

NOTE National languages may be used for "Air"

S Infonnation to be supplied by

manufacturer

8.1 Flow-metering devices shall be acc:omparrled

docwnents conta.in.i.ng at least a technical

instructions for use and an address to which the user

can refer The accompanying documents shall be

<'''' ~'''iI as a component of flow-metering

8.2 Instructions for use shall contain all information

ne<;esl!!alY to operate the flow-metering device in

ac_c:ordaIlce with its and shall include

eXl~laJllation of the function of controls, connection and

disconnection of detachable parts and accessories

Instructions for use shall include indications on

rec:ogJrIizE~ accessories and detachable parts if the use

of accessories and parts can degrade the

minimwn safety Instructions for use shall detailed

instructions for the safe of cleaning,

indicate the of such activities A

list of recommended spare shall be provided The

"h,~ ,."",nn.,." on the flow-metering device shall be

eJq:)laiJled in the instructions for use

White Blue Black-white Brown Grey Light ulUw!1 2)

3)

8.3 Particular attention shall be satetv'-rellat€!G items:

a) the of fire or arising from the use of l"h,ri "ITIi'<: not recommended by the manufacturer;

b) the of changing the connectors on flow-metering devices;

c) the of disassembling the flow-metering device while it is under pressure;

the etIect on the accuracy of flow which can

result from inlet pressure;

e) the etIect on the accuracy of flow which can

result from varying outlet ret:~isbf.lnc:e;

f) the etIect on the accuracy of flow due to variations in ambient from 0 <>C to +40

g) the effect on mechanical accuracy and leakage of the Dow-metering device to trnnsport and storage outside the .range of temperatures 8p€Cified by the manufacturer

© BSI 04-1999