INTERNATIONAL ISO

STANDARD 5361

Third edition
20t6-09-oL

Anaesthetic and respi{

tftii p frlinf Tra c-!rd\ and
e
cOnnectors -
M atdriel d'anesthdsie et respiratoire Sondes
tracheqlesetraccor^
trqchdales et raccordt \ -
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BIS LIBRARY

Reference number
ISO 5361:2016(E)

o ISO 2016
ISo 5361:2016[E)

d
COPYRIGHT PROTECTED DOCUMENT

@ ISO 2016, Published in Switzerland

AII righB reserved. Unless otherwise specifie{ no part ofthis publication may be reproduced or utilized otherwise in any form
photocopying or posting on the internet or an intransL without prior
or by any means, electronic or mechanical, including -eittrer
writien fermission. Permission can be requestea froir ISO atltre addresJ below or IS0's member body in the country of
the requester.
ISO copyright office
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 ISO 5361:2016(E)

Page
Contents
lv
Foreword...

L
2 Normative references" t""""" """" """ "
,.'.,'.'''.'z
3 5
connectors
4 *General requirements for tracheal tubes and tracheal tube 5
6
,6

6
6
6
10
13
13
13
,,',.,,.',...L4
i.o Inflating system for cuffs""""""""""" """"" f" """ "r:
T4
5.7 Curvature of the tube""
*RadioPaque marker"""'
16
5.8 *Kinkresistance"""""""""'
L6
5.9 T7
Additional requirement for L7

2:.,'*:*i:l.f,H'f'gK9.r'M:.M;ih;;y;''.'..'..''.".-.,..'.',.'..',......'......'-.',.,..'-.,-.....

l,--",,:**:'*::ffi6H;;,;;;;;;.";;:":":::::=1r :',7
it' i#;t-rifilfr$;;;;'h";it"ul'"'"il;;ilil;Jiie'ite ::
...'.'.':. ..1
Marking.......'.. ..

s.+ fuiil7n rracheal tube connectors " "" """" "

AnnexA{ ihrmat}e) Rationale "'

cuff diameter". ""
of eur'
Ltt:LEI urr'quu. vr
Anrffi;[hormatlve; ) Determination u
ffICf;;
Annex L tyr rrrdlrvtl rest" method-; ror
cufed tube collapse""" """"""" ?n
""" "" "" " 30
,

:- ,"--.. .^- ---cr,.^-aiarinn

*Test method for cuffherniation
Annex D ('normative)
Annex E Ltlllul
Anngx lrrduvs., Guidance
usrus"Y on design of tracheal tube connectors..........,....',.'
[informative) ??
for risk assessment "'
Annex F [informative) Hazard identification

Annex H [normative) Test method to determine

kink resistance"""""' """""""39
...............,..............41
BibliograPhY

Ilt
O ISO 2016 - All righs reserved
 ISo 5361:2016(E)

Foreword
IS0 (the International-0rganization for Standardization) is a worldwide federation
of nationalstandards
bodies Ilso member bodies)..The work.of preparing lhternational standarJiir
no.r*rry
carried out
through [So technical committees. Each member b6dy interested in a subleci ror-*tri.r,
a technical
committee has been established has the right to be represented on that committee.
tnternational
or:ganizations, governmental and non-governmental, in liaison with ISO,
t"f." p".t in the work.
"f* (lEA
ISO collaborates closely with the International Electrotechnical Commission
;; all maters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its
further mail enance are
described in the ISo/lEC Directives, Part 1. In particular the different approval
criterianJ ded for the
different types of ISo documents should be noted. This docum""t,""rtiri;'i"
editorial rules of the ISO/IEC Directives, part 2 fsee wwwi.so.orgTdirectives).
;;-Ji. e with the
Attention is drawn to the possibility that some of the elements of this docum
patent rights. ISo shall subject of
be held responsible for identifying any or all suci Details of
-not
anypatent rights identified during the development of the-do."urn"nt ction and/or
on the ISo list of patent declarations received (see wwwiso.org/nare

Any trade name used in this document is information given,for the

of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific pressions related to conformity
assessment, as well as information about ISO,s adhr principles in the Technical
Barriers to Tiade (TBT) see the following URL:
The committee responsible for this document i ic and respiratory equipment,
Subcommittee SC 2, Airways and related
This third edition can cels and replaces th;xlvond uhr# ltso 536r:201.2),which has been rechnically
revised.
ThroughoutthisInternation,,,,2g1@,inedinC|ause3orinISo4135appearinboldtype.
Throughout this International s{,g!ftg")tsfo. which a rationale is provided in Annex A is indicated
by an asterisk (*).

iv
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 ISO 5361:2016(E)

Introduction
performance and safety requirements for the design
This International Standard provides the essential
tubes are iniended to be inserted through
of tracheal tubes and trachear tube connectors. tracheal
in patients during spontaneous' assisted or
the larynx into the t.".ft"" t" provide " p"iuni airway
convey gases and vapours to and from the
controlled ventilation for short or prolonged durations to
trachea.
and protect the trachea from aspiration'
In addition, tracheal tubes with cuffs are intended to seal
clinical requirements' Cuff performance
A variety of cuff designs are availabte to meet particular
from the iecond edl on.
requirements with assficiated test methodt t.t"ii unchanged
without cuffs' have e dated from the
Reouirements for paediatric tracheal tubes, with and ic depth 'rks have been
prov-isions for g
,;il;;ilion io iti.rua" revised length marks and new in u
iftis edition because these aie commercially available and
"aa"al" when in position.
Tracheal tubes are also intended to conform as closely as possible

clinical considerations have also dictated the specified length

I tulls because long tracheal
may be,rl should be readilY
i"U"i, t"."times of relatively narrow- diameter' pre-cut
availa-ble. Provision has also been included for

o\fesist collapse and increased breathing

O ISO 2016 - All rights reserved

.,. i-.,*.
 ISO 5361:2016(E)
INTERNATIONAL STANDARD

Anaesthetic and respiratory equipment Tracheal tubes

-
and connectors

1 .Scope
and safety requirements for oro'tracheal
.' , This International standard provides essential performanceTracheal
and naso-tracheal tubes and tracheal tub" .or,n".to.s. tl*:-yltl,Kt:i::yf:t:9"Y1:l
ffit"T::ffi1:Tliirih-m;; wirh should";';;;.-*d tracheal nrhes tracheal tutes with means for
,- arlrar -ooac rnd tr'," -rit otherrtL&f tracheal tubes

'*'i""1i3#:ii-"?$::x":ffi{vtxi:f i'ffi nn;

i1i,r*ifft1;,lll*'J*xiili,ffi
airways
Endobronchial fincluding tracheobronchial) tulgs, tracheostomt4F*fipralaryngeal
e*ctud"d from the sc6pe ofthis lnternational standard.
"re
ts, lasers, or electrosurgical
Tracheal tubes intended for use with flammable anaestheti
;;;tp;;;i;re outside the scope of this International syqda
NOTE References gl to [4) deal with laser surgery

2 Normafive references
The following documents, in whole or
indispensable for its application' For
referinces, the latest edition of
medical
ISO 594-11), Conical fittings taper for syringes, needles and certain other
equipment- Part 1:
Conical connectors Part 7: Cones and sockets
ISO 5356-1, Anaesthetic equipment
- -
'rr" on equipment Registered symbols
ISO 70002), -
IS0 10993-1, ofmedicaldevices_Pqrt7:Evaluationandtestingwithinarlsk

for the development'

rso 1 ln of health care products
coitrot of a sterilization
- Ethylene o1id9 . Requirements
process for medical devices

development'
rso 111 terilization
-ioutin, of health care products - Radiation - Part 7: Requiremen* for
control of a steriliiation process for medical devices
validation

11607-1 , Packaging for terminally steriltzed medical

devices Part 7: Requirements for materials'
lso -
sterile barrier systems and packaging systems

of medicat devicesfor human subiects Good clinical practice

ISO 14155, Clinical investigation -
lso I497Lt2007, Medical devices Application of risk management to medical devices
-
ISO 15223-1 , Medical de:vices symbols to be used with medical device labels,labelling and information to
Part 7: General
-
requirements
be supplied
-
1) TobereplacedbYlSO 80369'7'
online in th; ISO web store' For more information' consult
n The eraphical symbols in ISO 7000 are also available
iiO'7J,"irr ii."."rg7iso/puhlications and e-products/databases'htm?='

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ISO 5361:2016(E)

symbols to be used with medical device labels,labelling, and information

lso Lszz3-1, Medical
i-be
devices
-
part 2: Symbol divelopment, selection and validation
supplie'd
-
of medical Requirem?!1ts_for medical devices to be designated
EN 556-1:20 0L, Sterilization
Part L: Requirements
devices
-
terminally sterilized medical devices
"STERILE" for
-
EN 1041, Information supplied by the manufacturer of medical devices

ASTM F640-12, standard Test Methods for Determining Radiopacity for Medicat IJse

ASTM D3O02-07, Standard Guide for Evaluation of coatings Applied to Plastics

3 Terms and definitions

nd the
For the purposes of this document, the terms and definitions given in ISO
413
following apply.
3.1
angle ofbevel
tube (3.27) at
acrite angle between the plane of the bevel (3J) and the longitudinal
the patientend (3JO

[SOURCE: ISO 4135:2001, 6.3.5]

Note 1 to entry: See Figures 1a.ib, and4'

3.2
bevel - A
slanted portion at th e patient end (3.16) of a trackal t

[SOURCE: ISO 4135:2001, 6'3.41

3.4
cuff and
inflatable bal lnflv attached around the tracheal tube (3,2,2) near the patient end [3Jd)
used to pro4e e seal between the tube and the trachea

Note 1 to entry: and lb.

3.5
glottic depth mark
the
indicator on the tracheal tube {3.27) to assist in determining the tip insertion depth beyond
vocal cords
3.6
inflating tube
tube through which the cuff (3.4) is inflated

[SOURCE: ISO 4135: 200 1', 6.3.6.L1

Note 1 to entry: See Figr.rres 1a and l[.

@ ISO 2016 - All rights reserved

 ISO 5361:2016(E)

3.7
inflation lumen
lumen within the wall of the tracheal tube (3.27) for inflating the cuff (3.4)

3.8
laryngo-tracheal portion
thatportion of aCole-typetrachealtube(3.3) of smalldiameterandextendingfromthe bevel(3.2)tipto
the point at which there is an increase in the outside diameter
3.9
machine end
thatend ofatrachealtube(LH)whichisintendedtoprojectfromapatient
I
[SOURCE: ISO 4135:2001,6.3.31 A\
Note 1 to entry: See Figures la. J.b, and 4. I Y

*'"lnr"" end of the tracheal tube connector

that portion of the tracheal tube connector (3.28) intended to fi?lQlFfrri
-S/ anaesthetic breathing
system [ABS) or ventilator breathing system (VBS)

3.11
Magill-type Facheal tube
curved tracheal rube (3.22) with a radius and having(berf{(32. ) atthe patient end (3.16)
Note 1 to entry: See 5.7.2 and See E C**+ fn, \
"na1A
s.r2 {t\
Murphyeye A \V
holethroughthewall of atachealrube(3.Xlneailhe patientend (3.16)andonthesideoppositetothe
bevel (3.2)

Note 1 to entry: See Figure 6.

3.13
naso-tracheal tube
tracheal tube (3.27) for in rbugh the nose into the trachea

[SOURCE: tSO 41

3.14
oral
that tracheal tube (3.3) of a larger diameter extending from the machine end (39)
to there is a decrease in the outside diameter

3.15
tube
tracheal tube (3.27) for insertion through the mouth into the trachea

[SOURCE: ISO 4135:2001, 6.3.1.1]

3.L6
patient end
that end of a tracheal tube (3.27) which is intended to be inserted into the trachea

[SOURCE: ISO 4135:20 0t, 6.3.21

Note 1 to entry: See Figures 1a.lh, and 4.

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 ISO 5361:2016(E)

3,L7
patient end of the connector
that end of the tracheal tube connector (3.28) intended to be inserted into the tracheal cube (3.27)
3.18
pilot balloon
balloon fitted to an infloting tube (3.6) to indicate inflation of rhe cuff (fu1)

[SOURCE: IS0 4135:200 L,6.3.6.2]

Note 1 to entry: See Figure lb.

3.19
risk
combination of the probabi lity of occurrence of harm and the severity of that harm

[SOURCE: $A 1497 L:2007, 2.167

3.20
risk analysis
systematic use of available information to identify hazards and to es

[SOURCE: ISO L497 l:2007, 2.L71

Note 1 to entry: Risk analysis includes examination of different s that can produce hazardous
situations and harm (see Annex F and ISO 14971:2007, Annex E).2

3.2t
risk assessment
overall process comprising a risk analysr's (3.20)

[SOURCE: ISO t497 l:2007, 2.18]

3.2,2
risk evaluation
process of comparing the esti inst given risk criteria to determine the acceptability
of the risk

[SOURCE: ISO 1497 l:2007, 2.2L1

3.23
risk management \ry
systematic-applicfrfulg.*"nt policies, procedures, and practices to the tasks of analysing,
evaluating, .X{r a) rtronitori ng rrsk (3. 19)

[SoU RC E: I.f,I4}[LE|*/, 2.22]

I.
-
nsKmanagememnte
set of records and other documents that are produced by rrsk management (3.23)

[SOU RCE: rSO 1497 7:2A 07, 2.231

3.25
shoulder
that portion of a Cole-type tracheal tube (33) at which transition from the oral portion (3.14) to the
laryngo-tracheal portion [3.8J occurs

3.26
si ngle-fault condition
condition in which a single means for reducing a rrsk (3.19) is defective or a single abnormal condition
is present

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 ISO 5361:2016(E)

3.27
tracheal tube gases and vapours to and
the Iarynx into the trachea to convey
ffiil&;;d
trachea
for insertion throush
from the
4135:2001' 6'3'11
ISOURCE: IS0

3.24
tracheal tube connet"lT" of a tracheal tube (3'27)
thi directly into the machineend (3'9)
tubular component
4135:2005' 6'3'81
ISOURCE: ISO
2 and 3'
Note 1 to entrY: See Figures

and trachea
+ *General requirements for tracheal tubes
to risks associated
specifie: re-qlrements that
are
This International Standard tube connectors'
with tracheal tubes "nd tracheal

4.L Risk assessment

e design of the device' '
process
4.L.t' An established risk assessment

EXAMPLE ISO 14971.

performed' these
of the risk Jltne. rr clinical studies are is claimed'
Check compliance by inspection :'#jiilil;. *ttitrt performance
ri" Jitt itt"'rl docu me.nt. I""t" I:T.."f
shall comPlY with
:* s oflSO 14155'
i'ffi;i""til,i,di.;
NOTE SeeAnnex F'
and
operated. in normal use'
ilroo.a"d, stored, installed' ;..' t"::
4.t.2 Tracheal tubes
maintained according to
#ffi
ih" manuracf,ul-et'
'o fr the
in accor
*if:
manu racture r u'i"""."'*tirt 3i: :::
iso r+gzt and?f iffi are
which
rt Drocedures
an accePtable level usin i;;;;J;a in single fault condition'
ionnected with their in
condition. Faultconditions/hazardous
NOTE A nnlx,, ""tdetectedis considered a normal
situations mi
risk. [n that
$fi:',:*:";if; ".:'""f,,1:lT.xil{ni
witnrn-thu ,irt In"n"g"*"n,
piiJ.tt i" i.l with such situations'
to be determined
risk contro
rn freedom from unacceptable risk'
the
I r a---r^-r
Standard -^For to
refer with
!bq{i."-"nts in this.lnternational ittu-*"nuf"tturer in accordance
4. risk:Pil*,l*?1niffi#
or unacceptability oI mis risk
:#:HtUiJ. i"i"'*1"i"s acceptable
of the risk management file'
Check compliance by inspection
engineering
shall address in a usabilitv
required bv a competet: T:l:,lYj,t:t f#:i"rt::\er
+'t'4 If requtreo
4.L.4
process the
"y.;;Hil;";;';'Jiriry Gee r8c62366)'
risk resulti
of theusability engineering file'
Check compliance by inspection

4.t.slfrequiredbyacompetentauthoriwaclinicalevaluationshallbeperformedanddocumentedin
the device'
tf,l'I".nni.^f dotu*"nt"tion of
of the technical documentation'
Check compliance by inspection

@ ISO 2016 - All rights reserved

ISO 5361:2016(E)

4.L.6 If required by a competent authority, and where appropriate, validated biophysical or modelling
research shall be carried out.

Check compliance by inspection of the technical documentation.

4.2 Safety

4.2.! *Tracheal tubes, when transported, stored, inserted, operated in their normal intended use, and
maintained according to the instructions of the manufacturer; shall minimize safety hazards which could
reasonably be foreseen to occuc in normal and single-fault conditions.

Check compliance by inspection of the risk management file.

NOTE Attention is drawn to any intended use that may deviate from the currently acceptd
See Annex A for examples.

4.2,2 The manufacturer may use type tests different from those detailed hternational
Standard, if an equivalent degree of safety is obtained. Alternative test met lidated against
the test methods specified in this International Standard.

s specific requirements for tracheal tubes and tRch$ connectors

5.1 Size designation

The size of tracheal tubes and tracheal tube rfbe designated in accordance with
Table 1a for tracheal tubes, Table 1b for tubes, and Table 2 for tracheal tube
connectors.

5,2 Dimensions
5.2.L Tracheal tubes

s.2.L.L The basic dimension 'e tracheal tubes shall be in accordance with Table 1a.

5.2.r.2 The basic dim Et rpe tracheal tubes shall be in accordance with Table Lb.

5.2.1.3 The desi6tl?{sfuf-the tracheal tube shall be the marked inside diameter subject to a
5,0 and smaller; and subject to a tolerance of +0,20 mm for sizes 6,5
:""58[:.:XVsiTes
andlarser.
V
Th" ^
n*"";t\B;eal tube should be essentially circular in a plane at right angles to the long axis.

S.Z.l.4 For Mafill-type tracheal tubes, the nominal outside diameter (OD) shall be the marked
outside diameter (OD) subject to a tolerance of +0,15 mm for sizes 6,0 and smalle[ or subiect to a
tolerance of t0,20 mm for sizes 6,5 and larger [see 8.2.1.1 b) 1)]. For Cole-type tracheal tubes, the
maximum outside diameter of the laryngo-tracheal portion (OD) shall be the marked outside diameter
(oD) [see 8.2.L.t b) 2]1.

5.2.1.5 For Cole-type tracheal tubes, the axial length of the outside surface of the shoulder region, 51
52 (see Figure 1c), shall not exceed 4 mm for sizes up to and including size 3.

@ tSO 2016 - All right-s reserved

 ISO 5361:2016(E)

Table la *Basic dimensions of tracheal tubes (see Figures 1a and lb)

- Dimensions in millimetres

Dimension C Dimension 51a, b

DimensionA
Designated Minimum length of tube Maximum distance from the Minimum distance of Point
size (see Figures la and th) patient end ofthe tracheal of separation of the inflating
(nominal tube to the machine end of tube from the Patient end of
inside the inflatable length ofthe the tube (see Figures 1a and
diameter) Nasal or oral/nasal OPala
cuffb (see Figures I a and 1b) Lh]

2,0 130 110

2,5 140 110

3,0 160 t20 33 I

3,s 180 130 35 I
4,0 204 140 4L
45 / 7-
4,5 220 150
- \
5,0 240 160 s6 t(, \ 110

J,J 270 t70 56 \ V r2o

58 -\
6,0
6,5
7,0
280
290
300
190
2t0
230
r'\.\
16
I LzS
135
140

7,5 310 240 ,A. \./ 145

8,0 320 250 .3, \ 72 150

8,5 320 260 \\r)= IJJ

9,0 320 270, --. Y78 160

9,5 320 280\ B1 165

rY L70

{ik
10,0 320 85

10,5 320 85 t70

11,0 320 l- 280 B5 t70
a Manufacturers wishing to market acheal tubes with tracheal tube con[ectors inserted are guided by the tube
lengths shown in the table. However, tltEltsI I that anatomical variations; conditions of use, the tength of the tube inserted'
frittt". ,oo tong or too short for a given iratient. Selecting the size and length of a
il:'ff : IillT :,.iiit;T*'J : il:ffi m and iudgment tJensure that it is appropriate to the needs ofa specific patient'
c may decrease likelihood of endobronchial intubations for paediatric patients
["" f I[:11:"'"'u'"'u*'"'\$]

O ISO 2016 - All rights reserved

 ISO 5361:2016(E)

Tabre 1b Basic dimensions of cote-type trachear

- tubes (see Egure_rc)
Dimensions in millimetres
Oral portion
Designated sizea Length of I
(nominal inside laryngo-
trachgal outside
diameter of tracheal Inside diameter Overall length
portion) portion diameter A
C
ofthe oral
dr d2 portion
d3
min max mrn max max mln max
1,5 24 3,9 5,0 7,0
1,75 110 140
20 24 4,L 5,0
2,0 20
7,0 L^ 140
25 4,2
2,25 25 30
5,0 7,0
, r20 vL40
2,5 25 30
4,3
4,3 5,0
7,0
\rzo \ 140

\#Z
7,5
3,0 t40

n)
25
3,5 25
30
35
4.3 5,0 7,5 A 140
5,0 6,0
4,0 130 150
25 35 5,5 6,5 / r4o
4,5 28 38 I 6,5 | 7,0
.A. loEZ r.50
160
For r5
170

Key
1 patient end
2 angle ofthe bevel
7 separatingangle
fsee 5.6.2J
fsee S.4) I region for markingsize
3 radius ofcurvature (see 5.7) [see 8.2.1.1 b)]
4 inflating tube
9 inflatable length ofcuff
a See 5-6.6.
J machine end
b See Table la.
6 alternative integral pilot balloon/valve
assembly c Minimum value for.S2
=^d -Sr.

Figure la Tlpical cuffed Magitt_type tracheal

- tube

O ISO 2016 - All rights reserved

 ISo 5361:2016(E)

Key
separating angte (see 5'6'2J
1 patient end
rggion for marking size [see 8'2'1'1 b)]
2 angle of the bevel [see 5'4)
inflatable length of cuff
3 radius of curvature [see s,ZJ
Seb 5,6,6.
4 inflating tube
See Tablela,
5 machine end
Minimum value for 52 = 4 - St'
6 pilot balloon
Y.,

f
features
fMagill-type tracheal tube showing alternative design

9
@ ISO 2016 - Alt rights reserved
 ISO 5361:2016(E)

Key
t patient end
2 maximum distance of start of curvature from beginning of tape
3 radius of curvature, approximately 50 mm (see 5.7.4)
_n:_
4 angle ofthe curvature ofthe tube from the machine end (45 t 15)'(see 5.7.4)
5 machine end
6 region for marking 20 mm min. [see 8.2.1.1 b)]
7 shoulder region for dimension 5r,.12 [see
8 smooth reduction of lumen (see 5.7.6)
9 maximum outside diameter of the portion that is marked (ODJ [see B.Z.L.Lb) Z)]

NOTE For dimensions A, B, C, d1,

Cole-type Facheal tube

-
5.2.2 Tracheal tubec
NOTE The tra nector may incorporate a suction port.

5.2.2.1 Tltta 'sions

of tracheal tube connectors shall be in accordance with Table z.

connector shall be not less than that of the tracheal tube with which it is provided.

5.2.2.3 The minimum inside diameter of a curved or angled tracheal tube connrector shall be
not less
than 80 o/o
of the designated size, and the corresponding cross-sectional area shirll not be reduced
by
more than 10 %.

5.2,2.4 A suction port, if provided, shall be designed so that its closure does not obstruct or narrow
- the
lumen of the tracheal tube connector.

5.2.2.s The machine end of the tracheal tube connector shall be a male L5 mm conical connector
complying with ISO 5356-1.

10 @ ISO :2016 - Alt righa reserved

 ISO 5361:2016[E)

s.z.i.o rhe inside d,"T?::t:[,f; ,f:tl'J3"Hff[X?T"S#jF 3:

diame'cer sha'r be
'm:[il.llf,:r:"f':;'"',""i:Hli
ill;" f*11:ll'"::l"tJ,f iot ttoottt passase ora suction catheter'
#,?;!,il1i',il';ifi*ffi"#!fj!#..'ij,'ff*,ffi::,;;tfiJJffill'ffi:,'lJ'inside
tapered to Permlt
an a

basicdif:TtTilxlJ tracheal tube connectors (fisure :j::"ffi

llilffi shall : 3), angle 0 be
wtrrt rsv'- - fi"i**;a
s.2.2.7rhebasicdiT:i:,i"""i.."i':t:ffix."*ffHil::iffi:"##ff
s.2.2.7 The
shall be in accoro?oce 'ffi
*gr"^r,
3)
than 45o'
sharr have a prane at
(e0 t 5)o to the long axis of the patient
1?;';?,nJ*;ff:i?ff:*i#ffJ:end
oftna facheal tube conneur""
"nA Size range and basic dim lnt end
Table 2 Tracheal tube connectors -
- in millimetres

Straight connector;;{, Cu\vedlconnectors

-
minimum dimensift, l1r
Designated size
tn"X",rtl$"t"' GmeTile_t:l$,\ T#:,.i,'j",Tiilii"n'o
Inside diameter)
fnominal

7,,0
tn ^A.\
9 ,
2,5
2,5
v ,,,. \-/
3,0
v / \ 11
3,5
) \ r11
4,0
-?--:c -,Y
AN
12
4,5
-q.,--t 12
5,0
5,b
ffi- v 13
13
10
10
-'6,0---\

wh
6,0 L6 10
6,s I L6 10
7,0 / L5 10

9
7,5 L6 10
8,0 lr F,0
t6 10
8,5
8,5
on t6 10

__-r,IJt- /
ffi
aq t6 10
L6 10
10,0

-_-a 10,5
L6
t6
10
10

1 1lL/length of th
11,0
|
,) ;.h"t tube connector is that length available for insertion into the
pauenr ^l t
itive
t"Jlili$ E

LT
@ $O 20L6-
All rights reserved
 ISO 5361:2016(E)

Key
machine
_1 padentendend fsee 5.2.2.5)
2
l1 effective rength of the padent
end of the srraight tracheal
d internal diameter of t}re tracheaf tube connecror
*nu.onnJ*o.
This figure illustrates
,I?:t,
Intended, as an eximple a tracheal rub,e connector
onry. . for the purpose
dimensions, and is

Figure 2 Straight tracheal tub

-
L

Key
1 machine end (see 5.2.2.5)
2 pafientend
12 effective rength ofthe patient
end ofthe curved
trachear tube connector
fsee Tabre 2J
,Tglt, asThis
tntended
figtrre illusrrares a
an eximple only.
rracheal tub.
---e connector for the purpose
of defining basic dimensions,
and is

Figure 3 Example ofa curved

- tracheal tube connector
t2
O IS0 20 I 6 - Ail rights
reserved
 ISO 5361:2016(E)

5.3 *Materials

and tracheal tube connector in its ready-

5.3.1 Those parts of the tracheal tube, including the cuff membranes'
for-use state, that .onr"-into iontact with the patie"nt's.respiratory
gas
Pglhy"V or mucous
indicated in IS0 10993-1'
shall satisff appropriate biological safety testing as

s.3.zThemarkingoftrachealtubesshallbedurableandlegible.
check compliance by inspection, as indicated in ASTM D3002'2007,6.4'l'
and marking
S.3.3Ifintendedandmarkedforreuse,trachealtubesandtrachealtube of cleaning,
materials used on tracttear tubes should be resistant
to deterioration by
Such shall withstand
il;ili";ii";, and sterilization recommended by the manufacturer. r methods of
The recom
,n.tt,oos of sterilization recommended by the manufacturer. safety of
the materials which will co
,i"rifir"tion shall not produce changes in
the tracheal tube and tracheal tube connector'

Check compliance by inspection of the risk management

file'

5.3.4 If required by a competentauthority, and if phthala

rtrated in parts of the medical
"_-a-----
medical device shall be labelled
a.uii"t .oting direitly or indirectly into contact with the
accordinglY.
tagenic, or toxic to reproduction'
NOTE Attention is drawn to substances which a

5.4 Tracheal tube bevel

5.4.L Tracheal tubes shall have an angle' ofifA t 10)". Cole-type tracheal tubes shall have an
angle ofbevel of(45 t 5)".

*The bevel should ha facing to rhe Ieft when viewing the rrached nibe towards
5.4.2 '*h$f"*lfo Fisures 1a' th' and I'c)
ISYOee
lieal tube at the bevel shall be free from sharp edges'

5.5

shall be integrally attached to the tube and inflatable

in a leak-free manner'
5.5.1 A
of 1'5 times
gly inrhting the cuff to a pressure of 9,0 kPa [90 cmH2o) or to a diameter inflating
er as determined in Annex B. whichever .o*"i first, with a syringe or other
the
i"ff"tittg system. Detach the syringe or other inflating device'
device.
observe for bubbles for a period of not
SuUmergeit e entire inflation system of the tube^in y1tT 1,nd
L;; iti;
10 s. No bubble shalt bL noted over the 10-s interval.

tube to the machine end of the

5.5,2 The maximum distance from the patient end of the tracheal
1b) shall be as given in Table La'
inflatable length of ttre culitaimension C in Figures 1a and

S.S.3 The maximum cuff diameter shall be within xll o/o of the marked value [see 8'3'1 k)]' when
determined in accordance with Annex B'

in Annex c' the steel ball shall

5.5.4 When tested for tube collapse according to the method described
pass freely through the tube'

L3
@ IS0 2016 - All rights reserved
 ISO 5361:2016(E)

5'5'5 when tested for cuff herniation according- to the

inflated cuff shart reach beyona tn" n""r"ri method described in Annex D. no part of
of the bever (see Figure
the
"ag" D.1).

s'5'6 *when tested for tracheal seal according to Annex G. the cuff shall limit leakage
liquids when inflared ro inrernar p."d;;;;r and aspiration of
exceeding 2,7 kpa (27 cmH2o).
Compliance is checked using the static
test method in Annex G.

5'5'7 The cuff and the transition between the outside

points of attachment shall be free of surface of the main tube and the cuff
shaip Jges. at the
compliance is checked by inspection
of the risk management f'e.
5.6 lnflating system for cuffs
IY
-\ \
lt,* ^"1!: in{3Unq
rub.e, if provided,
sha' have an outside diamerer of nor
on the concave aspect of rhe tracheala (e rrT slrmm and the
:,",I:r"r;ili:il"^T.Tljg:-rjly,"a .,1\!e)Acheat tube is
rtracheal tube by
ffi ff i[{l'lH**f The dimensions of

1.6.2''filL*,f
The angle o"y"_"lthe infla_ting
',,',ffi*ffiiJ,l[i1trffi
tube and the traffi*o.V point of separation
Figures laandlh) sharr notexceed45o. /t \ (see

The inflating tube shail have a pilot ba[oo

l;9f
ot the cuff. vice to indicate infl ation/deflation

5.6.4 The intentionaldeflation of the cuff

or any closure device acting as a non_retunf nted by the inflafing tube, inflating valve,

5.6.5 *The free end of the i

inflation valve, but in all instan< be either open or sealed with a closure
'of accepting a male conical fi"ir,s;i device or
tapel complying wfth ISO S94_ h 6;/o ftuer)
"
5.6.6 Dimension Sr of
inflation valve or cloiurd lsee Eigr,uesJa and 1b) shall be at least 40 mm,
unless an

r'v'' rr d crosulD oeudlislprovided, dimension

i,fii"-:,1S1@-
barloonangft r$t -"" s3 shall be not less than 10
mm, unless the pitot
";Ji",&;;i
f,InTF
r\\, I E \^\
r hrsyacilitate clamping
^4.
of the inflating tube.

5.6.8 If rhe distfnce

patienrend
patienr inflating.tube
end is marked pee n':\,"f:ff:*{:1"
rj"'$a.b.tij1;d;';;d and the rracheat tube rrom
d#;::;illfi|?ffiH:l,*:ffi:["flt#be from rhe
the

5.7 Curvature of the tube

5.7.1 Tracheal tubes may be straight

or curyed.

s'7'2 If a tracheal tube i-s described as a Magill'type

(740t 20) mm for tubes of rir;;;,;;l"ri.e".ir"" "Fis,; trachear tube the radius of curvature
sha, be
;. ;i. and {), excep*hat:
ar
*::fiil1H""r,il":i,??:,j:.f,fi?L\n?,1,fl,"":,:L:*j:l r: ne: more than 30 mm beyond the
tangential f,:ifj:l:;T,,i:;Ed,;U?;lf',":"'ffi ffi"i,T#[tff":T:f,i,;H,,:.J3ff
;ffi liffi to rhe curve of the tuBE $, be

t4
@ lSCl 2016 - All rights reserved
 ISO 5361:2016(E)

b) this curvature may be omitted from uncuffed tubes of sizes 6,5 and larger over the same equivalent
distance as for cuffed tubes in a).

5,7.3 Curved tracheal tubes of sizes 6,0 and smaller may have a radius of curvature other than
(140 r 20) mm.

5.7.4 Cole-type tracheal tubes shall be smoothly curved to a radius of about 60 mm so that the
machine end makes an angle of (45 t 15)" to the patient end as illustrated in Figure 1c. The curvature
shall start within 20 mm of the beginning of the taper (see 51 in Figure 1c) on the outside surface.

5.7.5 The tracheal tube shall maintain its intended shape when removed from tb{original packaging
in accordance with the manufacturer's instructions.

5.7.6 The tracheal tube shall have smooth outside and ompliance by
inspection of the risk management file.

Key
L
') angle\ghe bevel (see 5t[)
3 radius 6f curvature fsee 5.Z)
4 region for marking size [see 8.2.1.1 b)]
) machine end
a Minimum length, A (see Table 1a).

Figure 4 Tlpical uncuffed Magill-type tracheal tube

-

@ lS0 2016 - All righs reserved 15

 ISO 5361:2016(E)

Key
1 patient end
2 straight portion
3 radius of curvature (see !/)
Figure5-[picaltrach
"",*&:,"",
5.8 *Radiopaque marker \)=
If a tracheal tube is labelled as marker shall be radiographically
distinguishable from that'of the al
exposing the tracheal
Check compliance by inspect fg Test Method B in ASTM F640,
tube and an aluminium coml comparison standard shall be a piece of
ifiealuminium
aluminium (1 x 1 x 10) mm, or

5.9 *Kink resista

the rnethod described in Annex H' the
When a tracheal D-t fo. kink resisrance according to
steel ball sha rough the lumen of the tracheal tube'
to the patient's anatomy
When in tube should be flexible and soft enough to conform
without exerti pressure on the body tissues.
The materials used for the manufacture of a tracheal tube should have sufficient rigidity to allow the
construction of a tube with the thinnest porrilf. *rff which, at the same time, maintains the resistance
to collapse and kinking.
The resistance to collapse and kinking white providing adequate ftexibility to prevent harm shall be
evaluated by inspection of the risk management file.

16 @ ISO 2016 - All rights reserved

 ISO 5361:2016(E)

6 Additional requirement for tracheal tubes with a Murphy eye

6.1 Size of the MurPhY eYe

g0 0/o of the cross-sectional area derived from the
The area of the Murphy eye shall be not less than
minimum inside diameier iltowed by Table 1a for that size tracheal tube'

6.2 Location of the MurPhY eYe

The location of the Murphy eye shall be on the side of the tube opposite the bevel (see Figure 6)'

6.3 Resistance to kinking or collapse of the Murphy eye

The size, shape, and location of the Murphy eye shall be such that Ih_.. P? ient end e tube is not
unduly p.one to kinking/collapse. The resistance to compression shal!!{ evalualed y inspection of
the risk management file.

Figure 6 Patient end of a tracheal tube showinga Murphy eye

-

7 Requirements for tracheal tubes with tracheal tube connectors supplied sterile

7.1 Sterilityassurance
Tracheal tubes with tracheal tube connectors supplied and marked as "STERILE" shall satisfy the
requirements of EN 556-1:2001,4,1 and, if applicable, ISO 11135 and ISO tL137-L.

@ lS0 2016 - All righs reserved L7

 ISO 5361:2016[E)

7 '2Packaging for tracheal tubes and tracheal tube connectors supplied

sterile
Each tracheal tube with a tracheal tube connector
supplied and marked as "STERILE,, shall be
contained in an individual pack. The pack shall serve
as'in effective barrier to the penetration of
microorganisms and particulate material, in accordance
with ISo 11607-1. The pack shall permit the
aseptic extraction of the contents and shall not be
has been opened,
--r--- ori.-.r*u.. without clearly revealing that it
- - capable
. .;
8 Marking
8.1 Use of symbols

If required by a competent authority, marking of tracheal

tubes, tracheal tuue conndt
inserts, and information to b^e^supi]I._d by t[e manufa*ure.
appropriate symbols in ISo 7000 0r ISo tizzs-t and ISO
t-rr"ir ."nJt;rh
;-r.i rdir

S/
1522g_2-.

8.2 Marking on the tracheal tube

8.2.1 Marking on the tracheal tube shall include the following:

a) the nam-e andfor trademark of the manufacturer or su

the patient end of the
tracheal tube below the oral/nasal cut line or point ofl
of t e inflating tube;
b) the designated size (nominal inside diameter) in
ySn
expressed in millimetres, marked in the region fg
lf
$l and the outside diamere4
and length as shown in Figures 1a.
-1b, Lc and 4, as appropriate, on the side of"the rom the patient end to the machine
end. Uncuffed tracheal tubes shall have th
size and outside diameter rnarked in a
region equivalent to cuffed tubes of similai
narkings shall be in accordance with one of
the following formats: The figure deng\S the iameter shall be larger and in bold type.

;l#:;'-:'Jr'
2) For Cole-type
diameter of the lary
",*p lfmarking of the size together with the maximum outside
I portion (oD) shalt be situated on the bever
portion within side of the oral
h of the tube reading from the patient end to the machine
end fsee
EXAMPLES TR 3,5/5,5 OD or tD 3,5 / 5,5 OD
cJ For intended for re-use, the words ,,single use', or equivalent.
d) Length s) in centimetres measu.red from the patient end
in 1 cm or z cm increments on at
least 60 %
|e minimum tube length from the *"chin" end. If the lenoth mertrrcr nn rha hrfi^n$
omitted. The length qartis r.t nu
to 340" when viewed from the"ttmacirine end of the trichear
tuLe.-
EXAMPLE with the tracheal tube bevel facing 9
otlock, the length marks are situated on the upper left
quadrant of the tracheal tube when viewedlrom
the machin-e1"i'1i.". near the g o,clock and 11 o,clock
position on the surface ofthe tube when the concave
aspectofthe tube is held atthe ri"fr".t position).
e) For uncuffed tracheal tubes of nominal size 3,5
mm or smalle4 length marks should be in L cm
increments measured from the patient end with
tn" ri.si rari, 3 cm from the patient end. The
length marks shall cover at least 60 o/o of the:riniruniiai-r"ngtrr
length marks shall be positioned on rh;p"d;rt*;ffi|*" from the machine end. The
viewedfromthemachineendofthetracheatIub: oiit" *i5rr"m at least z70o to340" when

1B
@ IS0 2016 - All rights reserved
 ISO 5361:2016(E)

0 The word "Oral", "Nasal", or "Oral/Nasa[", as appropriate.

8.2.2 *Glottic depth mark:

a) For uncuffed tracheal tubes, a glottic depth mark shall be provided to assist in.positioning the
tracheal tube within the tra;he;. The glotiic depth marks shall be visible on the tube when viewed
from the machine end of the tracheal tube from at least 340" to 20". The position of the glottic
depth mark from rhe tip shall be disclosed on the individual package (see 8.3.2 a) or c)1. Additional
glottic depth marks may be provided.
EXAMPLE

With the tracheal tube bevel facing 9 o'clock, the glottic depth marks are visible lrd the upper quadrant
of the tracheal tube when viewed from the michine end (i.e. between ttre 1!! k and the 2 o'clock
position on the surface of the tube when the concave aspect of the tube is held att ojclock position).

NOTE 1 Unlike the length marks, the glottic depth marks need to be ofthe tube during
laryngoscopy.

NOTE 2 One example of such marks is shown in Figure A.1'

b) If a cuffed tracheal tube is provided with a glottic depth form to the requirements
in8.2.2 a).

8.2.3 Marking materials shall be of a colour that with the colour of the tube.

8.3 Marking on the tracheal tube any insert

8.3.1 The following shall be marked through, the tracheal tube individual pack
and may additionally be given on an insert:
ion of the
inflating tube and
b) a description ofconte

c) ;f,f\f 'roral/tlasal" as appropriate for oro'tracheal tubes or naso-

the word "0ral", !f
trachealtubet \/
d) the des inal inside diameter) in accordance with 5'1:

e) the expressed in millimetres;

0 trademark of the manufacturer and/or supplier and, if required by a competent

tylifdevices imported into the European Community, in view of their distribution in the
nity, ttre label, or the outer packaging, or instructions for use, shall contain in addition the
namil!frd-address of the authorized representative of the manufacturer established within the
community or of the importer established within the community, as appropriate;

s) the batch number and, if required by a competent authority, for devices imported into the European
Community, preceded by the word "LOT";

It is strongly recommended that the "use by" date be given, expressed as the year and month.

hl the word "STERILE" if appropriate fit is recommended that the method of sterlilization be given);
i) for tubes not intended for re-use, the words "single-use" or equivalent;
NOTE If required by a competent authority, the attention of manufacturers is drawn to consistent use of
indication across the community for single-use devices.

@ IS0 2016 - All rights reserved L9

 ISO 5361:2016(E)

jl if the straight portion of the tube extends beyond the machine end of the
cuff (see 5.7.2), this shall
be stated, for example, by the words ,.straight patient end,,;

k) *for cuffed tubes, the cuff

diametec determined in accordance with Annex B and expressed in
millimetres to two significant figures;
EXAMPLES

arithmetic mean of 9,25 mm is marked as 9,0 mm;

arithmetic mean of 9,26 mm is marked as 9,5 mm;
arithmetic mean of 10,49 mm is marked as 10 mm;
arithmetic mean of i"0,50 mm is marked as 11 mm.
n unless the tracheal tube is intended and marked as being for single
use, uctions forXleaning
and disinfection or sterilization and the maximum numbei o, p"ri"od
of ,. ll he marked on
the tracheal tube package or on an insert.

IqTE If required bya competenrauthority, the attention of manufi

indicationacrossthecommunityforsingleusedevices. consistent use of

m) If required by a competent authority, and if phthalates are i

in parts of the medical
devices coming directly or indirectly into contact with;tftr pati
medical device shall be
Iabelled accordingly.

NOTE Attention is drawn to substances which are tagenic, or toxic to reproduction.

8.3.2 The following shall be marked on, or

may be given on an insert if it is not practical
the tracheal tube individual packgf
nts to apply this information:
a) for uncuffed tracheal tubes, the dista millimetres, from the tip of tracheal tube to
the machine end of the glottic
b) for cuffed tracheal tubes wi !d size of 6,0 mm or less, the nominal distance, in
millimetres, from the tip of to the machine end of the inflated cuff (dimension
1a); C in
Table '
c) if provided for cu the nominal distance, in millimetres, from the tip of tracheal
tube to the machi depth mark(s).

8.3.3 The fol rked on the tracheal tube insert:

a)i ation of the tracheal tube prior to use. If the instructions for preparation
uFof an additive substance, the type and amount of any apprieJ
iubstance shall

b)
marked on any insert:

the.tested cuff pressure in hPa (cmH2o] and associated leak

rate in ml/h reported as the 50th
and..90th percentile of tesied for the minimum and maximum trachea diamerers
-samplei
(millimetres) in which the designated tracheal tube size is
intended to be used, in accordance
with Annex G:

the information shall be accompanied with the following statement:

"the performance information shown below was

collected using a bench test that is intended to
provide a comparison of the sealing characteristics of
tracheal"tube cuffs only in a laboratory
"
setting and is not configured or intended to predict p"rrormaniein
ttte crinicai settinJl

20
@ ISO 2016 - All rights reserved
 lS0 5361:2016(E)

EXAMPLE FORMAT (using example data)

bench test that is intended to provide
The performance information shown below was collected using a
cufFs glly il a laboratory setting. The bench
a comoarison of rhe r.;iiil;-h;r*,eristics of tracheafltube
;;'iril;;"ifu"i"a or intended to predict perform{nce in the clinical setting'
Tracheal tube cuff Performance sizeT,S mm tracheal tube

Minimum trachea diameter:

18 mm
Leakage rate range (ml/h)

ofthe instructions for use.

c) Ifrequired by a competent authority, the date ofissue or

8.4 Marking on tracheal tube connectors

mal designated tracheal tube size (nominal
The tracheal tube connector shall be clearly
inside diameter) in accordance with 5.1' (

4F

2l
@ ISO 2015 - All rights reserved
 ISO 5361:2016(E)

Annex A
(informativeJ

Rationale

General

im.porrant requifements orrhis Interna

]lill,lgJ"flj:;::f:li::::.I:::1""f"_1.:1.r" jff I Standard
n:iJ',''JJ::i;l,':i ;1',.,?',:g{::g;.rry'il;;ifi il::ffi ::iffiti,",:[?: ,,.ff,ii , butwho
ii::::'1:::1.::::::ll'-".'
change it is believed ttrat
j-,:o.l*."*i;;;,il;'i,fiilff:::::i,X?:i
"urr' rLrr Lrrel'more' as cllnical p
Interiationilsi""a*a
Internationar
ratiJnai* riilir" will facili
standard neces.sr:rcrf
necessitaiea x.,
by ru^"^lll:^:l::"q"""meirts
;h;;; ffi#;""'li::'-"1 s of this

International
Clause l. Scope
-
The scope has been expanded to
include so_
lll*::::::qu.iremenrs.rsJreJ speciar,,r,,#ll"i;n::l?K-*:M,:::T::,rJ.:h.Te
in clinical use wlile
manv
the use of
cdsl'lse
r;li:;HTl[::""".H1:::hl:.,tr,ftTffi:J#Fis\|i
ventilation masks, and other auri."r.ii0fdiie ru rr*r airways, non-invasive
\Lu/zlaryngeal
Clause
Slause 4 General requirements for tracheat
- tracher, tubfi
OA*Q at tube connectors
This clause has been revised to include
associated with tracheal tubes. arr"ll! eryDrmancg and risk management principles
The need for a risk management
of a nredical device can ide"ntifv
h:
risks associared with these naiJ|
Clinjcal evaluation may also b6
additional information.

4.Z Safety
-
Examples of an
t may deviate from the currentryac[epted
Ibut are not li medical practice may incrude
Ing:

- for rhe parient poputation of inrendgd

::::11f-*,ons
a recommelon that a specific distal
use;
depth mark be placed ip a specific
anatomic rocation:
a recommendation that the cuff pressure
should be monitored
$ontinuously;
a recommendation that the
- cuff shourd not be fuily defrated
whire in vivo:
a recommendation that the
tracheal tube is not intended for us!
such as premature infants in a specific population of patients,
infants
Table 1a-
";il;iil;age ";ailil;".
Basic dimensions of tracheal tubes
Table 1a has been revised
to incrude dimensions for
tubes' These dimensions were not cuff pracementon' size_ 3,0; 3,5;4,0;and
included previously a"rio 4,5 tracheal
tr," ri{nited dse of small cuffed tracheal
H?""-t#,'ff#::nowrommo;ti'".."piJ;"nd;;;;* "r*i,"i'"gs to uncuffed trachear tubes and

22
O ISO 2016 - All rights reserved
 ISO 5361:2016(E)

While many major clinical trials validate the use of current commercial cuffed paediatric tracheal
tubes,[12][lll[14] others reported adverse events and point to the lack of a convention among
manufactured designs.tl5ltf6t fhe dimension C in Table la for sizes 3,0 to 4,5 are those developed by
consensus among participants in the systematic review of ISo 5361.

5J - Materials

Although material biocompatibility is important for all tracheal tubes and other airways, it was
considered of special importance for tubes that might remain in situ for weeks. Anaesthetic agents
would not be in contact with the tube marking materials for such long periods of time, but these agents
might be damaging to marking materials.[Z]
5,4.2 Bevel
-
The committee understood that other bevel configurations may be not change the
existing recommendation for a left-facing bevel because it was believed t{provide i d usabilitv
and clearer visibility of the vocal cords during intubation.
,\ )
5-5
- Tracheal tube cuffs \ y
ded due to the critical function
fiiquids. Iiequirements added
armonize the pressure limits to

5.5.6 Tracheal seal

-
Requirements for the performance of
the trachea using so-called high-volume,
and aspiration while limiting damage
similar to those reported by many
anatomically scaled D-shaped trachAt m
tube sizes.[Z]t181t191 The use of
second edition to reduce in
standardize on more widelySy
te to the well recognized need to seal
cuffs to reduce the risk of hypoventilation
The requirements and test methods are
for 30 years, Early researchers employed the use of
for evaluating only a limited range of tracheal
rstic cylinders as trachea models is recommended in this
variability associated with more complex models, and to
of cylindrical trachea model sizes.

5.6.5 Luer connector

-
The committee u it is necessary to provide a means to quickly and safely inflate the
cuff that is ilable t6 all operators, under all conditions, especially in airway emergencies.
The common int 5eyringe with a Luer connector was chosen because it is readily available
to all heal rs worldwide and this provides a wide margin of safety and usability. The
'associated
significa with the hazardous condition of misconnection was considered and
jud due to low frequency. Use of unique small-bore connectors designed to prevent
considered, but the committee believed that the residual risk associated with a
requl for special inflation devices that employ these unique connectors was greater than the
riskof m lon.

5-g Radiopaque marker

-
The requirement for radiopaque markers is intended to allow visualization of the tracheal tube when
verification of the depth of intubation is required. It was originally required in ANSI Z-79.16,14 where it
was stated that for long-term intubation, in contrast with short-term use, radiopaque markings were felt
to be of major importance, in orderto check the position of the tube tip in relation to the larynx and carina.

59 - Kink resistance
Tracheal tube kinking and collapse is commonly associated with the risk of increased work of
breathing and hypoxia even in patients that are mechanically ventilated. Tracheal tube kinking and
collapse is also commonly associated with difficulties in inserting and removing bronchoscopes or

@ ISO 2016 - All rights reserved 23

 ISO 5361:2016(E)

suction catheters' The kink resistance measurement employed in this test is similar to that in Anne.r C.
requiring the passage of the same steel ball.

8.2.1.2.One example of additional marks that may be provided to assist in positioning the tracheal
tube within the trachea is shown in Figure A,1.[201

Key
1 (5) black horizontal lines approximately 1 mm wide
five.
2 black vertical lines approximately 1 mm wide spaced 1 mm a
3 datum 28 mm to 32 mm from upper edge of cufF, minirnum.I
IDIQ"a\
4 machine end of marks
\r\
)
6
7
fransition
vocal cords
mark must cover 340o to 20o measured cloc
\v curvature on long axis
a 9,5 mm to 10,5 mm. ll
3) 3re r example only.

Figure A.1 Example of to assist positioning the tracheal tube within the
- trachea

8.3.1 k) on tube individual pack or any insert

-Marking
This Interna quires that the cuff diameter be marked on the unit package, as this
information n to match the product to the application. characteiisticJof cuffed
tracheal t ER/clinical relevance can be characterizedby a combination of the tube inside
and outside eters and by the cuff diameter. The relationship between the cuff diameter and
tracheal r one of the factors that determine the intracuff pressure required
to provide a seal.
Excessive pressu on the tracheal wall may obstruct capillary blood flow.

For cuffed tubes intended for re-use, information about the cuff diameter is required
to be marked on
the-package or insert, but not on the tube itself. This is because re-use may alter
the elastic properties,
and, thereby, the cuff diameter.

Annex D Test for cuff herniation

-
Cuff herniation is a term widely understood in clinical anaesthetic practice. It is used
to describe a cuff
which protrudes excessively at its patient end so thar it partially
the orifice
at the bevel' Herniation may be due to a variety of causes, alone,";."-pi";ly;;;1"1",
or in combination. These include
overinflation of the cuff, retraction of the tube when the cuff is inflated, and deterioration
of the
material of the cuff.
ANNEX G Test method for tracheal seal
-
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 ISo 5361:2016(E)

performance by establishing a fixed

The aim of this bench test procedure is to assess the cuff sealing
,"1 of r.p*aucible criteria and rnethods that can be used to compare the sealing characteristics'

the effects of as many

The procedure is standardized to reduce test-to-test variability and to eliminate
extrineous variables as possible.

To provide a tracheal seal, the cuff shouid be designed with sufficient diameter and volume to minimize
.o*p"nsit. for of varying sizes, 2) dilation of the
;;"";;;; i"jury protong"J-u"t tilatiJn, a"a i1 reduction1)oftracheas
to the trachea and yet
cuff-volume as the cuff is compressla !v
il;;d; auii"g testing is
rising inspiratory p.""rrurur during'mechanical ventilation.[zil Therefore, tracheal seal range of
performed in transparent cylinders isin Annex G that represent the minimum and maximum
irachea diameters in which a specific size of tracheal tube is intended for use. I
cheal tube cuffs
The bench test is intended to provide a comparison of the sealing characteristig{[
predic b,rmance in the
only in a laboratory setting. The bench test is not configured or intended to
clinical setting.

^$
4P

rights reserved
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 ISO 5361:2016(E)

Annex B
[normativeJ

Determination of cuff diameter

8.1 Principle
The cuff diameter is measured when the cuff is inflated with an
internal pressure2whfth ..*ou",
creases, but minimizes stretching of its walls.

8.2 Apparatus

8.2.1 Means to inflate the cuff with sufficient air to create an

cmH20) t5o/o.

8.3 Procedure

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 ISO 5361:2016(E)

Annex C
[normative)

Test method for cuffed tube collapse

C.1 PrinciPle 1

v
through the
to-inward cuff pressure is tested bv nassinggSfball
The resistance to rube collapse due cyunuer'1
;;;;i;;i tube lumen *itt, ttt. cuff inflated within a transparent >
C.2 APParatus
c.z.l.rhansparentcvrinde-Jmaf egl-sl3s^s:11'*1*1'j;ffi
diA:::::11 Hff :::t$1!
the effective length ittt qg, ind
aniniide diameter of the tracheal
orlt'" ain"t"nce of cuff diameter and
"f
il;;;;;d:o't'(see Figure
tuUe unaer test C':t )' t\
controlled at
C.Z.Z Water bath, thermostatically
'given in Table C.1.
C.2.3 Air supply, capable of providing air
the pressures given in Table C'1
with an
C.2.4 Air Pressure indicating
accuracy of t5
o/o.

of the tracheal
designated size (nominal inside diameter)
C.Z.S Steel ball, of diametel
tube undergoing testing'
Z Selection oftest inflation pressures

T*i." th.t"fGA inflation pressure or 2'7 kPa'

kFfand <33,3 kPa

Reference inflation Pressure

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 ISo 5361:2016(E)

C.3 Procedure
C.3.1 Set up the apparatus as
illustrarea in.Eiguref-1.

Key
1 machine end
2 tracheal tube
3 pilot balloon 8 inflating tube
9
4 T-piece witi
connector to fit in
10 water bath at (40
J pressure-indicating device r 1) .C
6 11 transparent fube
stopcock
L2 patient end

Apparatus for tube collapse

- test
c.3.2 P
of the trachear tube into
is centrally the tmnsparent cyrinder
(c,J)so that the cuff
C.3.3 Artach thdnnaUng tube
to the air supply (C.2.3).

cuffwith air until itiust

,1r'"1"i:'L"$the makes circumferential
contact wirh rhe ilnrernar
surface of rhe
NOTE For transpa
aeterminin! tir;;;''"#Xl-T.',i?.:fi,:i:;lilor a small quantitv or corouring, ror exarnpre, ink, can assisr in
c'3'5 Immerse the tracheal
tube and the transparent
cyrinder in the warer bath
(c.2.2J at [40 r 1) ,c.
C.3.6 Adjust rhe yol
transpareffiffi""."iJjff,?li,#.,lli cuff so that circumferentiar conract with rhe
internar wa, of the

28
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 ISO 5361:2016(E)

C.3,7 After 30 min in the water bath and with the inflation volume of air in the cuff adjusted so that
circumferential contact is only just maintained, record (C.2,4) the inflation pressure of the cuff (reference
inflation pressure). Select the test inflation pressure appropriate for the reference inflation pressure
obtained as given in Table C.t.

C.3.8 With the tracheal tube in the transparent tube, inflate the cuff with air to the test inflation
pressure deterrnined in C.3,1 to C.3.7 and maintain the pressure for 24h in the water bath at (40 t 1J 'C.

C.3.9 At the end of the 24 h conditioning period, check the cuff inflation pressure and adjust if
necessary. Check the patency of the lumen by dropping a steel ball (C.2.5) through the lumen of the tube.

C.4I Expression of results

Record whether or not the steel ball passes freely through the tube.

^$
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ISO 5361:2016(E)

Annex D
Inormative)
*Test method for cuff herniation

D.1 Principle
The tendency of the cuff to herniate beyond the plane perpendicular to the long f the tube
at the nearest edge of the bevel is tested by applying an axial force with the cuff within a
transparent tube.

D.2 Apparatus
D.z.L Apparatus as specified in C.2.1. C.2.2,C.2.3.andC.2.4.

D.2.2 Weight, of mass 100 g.

D.3 Procedure
D.3.1 With the tracheal tube in the transparent ci ), inflate the cuffwith air (c.2.3) at the
test inflation pressure determined in Annex C, bp{ping um of 5,4 kPa and maintain the pressure
for 24 h in the water bath (C.2.2) at [40 t 1) 'C.

D.3.2 At the end of the 24 h condi remove the tracheal tube and transparent tube.from
the water bath. Check the cuff inflati lre alfrd adjust if necessary.

D.3.3 Invert the tracheal sparent tube and, holding the transparent tube in a fixed
position, gently suspend a 100 g from the tracheal tube as shown in Figure D.1. for not
fess than 60 s. . Y
D.3.4 observe *Uer&tdtFfff"f the inflated cuff reaches beyond the nearest edge of the bevel, as
shown in Figure
T. Colfndltte
10 s while contind
test by progressively.deflating the cuff over a period of not less than
erlring the configuration of the cuff.

Record whether or not any part of the inflated cuff reaches beyond the nearest edge of the bevel, as
shown in Figure D.1.

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 ISO 5361:2016(E)

Key
1

z
3 cransparentube , \--
4 rnr-rareqcurT \Fl Z
J
6

"H:T#lb_y
^^' \'
tl
Figure D.1
- Apparatus for cuff herniation test

^4.
.tL-t
t
,-.\-
\
,

3L
@ ISO 2016 - AU rights reserved
ISO 5361:2016(E)

Annex E
(informative)

Guidance on design of tracheal tube connectors

be lightweight, but have sufficient strength to resist deformation

8.1 Tracheal tube connectors should
under normal conditions of use'
r minimal
8.2 Tracheal tube connectors should be designed to-have minimal dead space an
rurirt"n." to gas flow The lumen should be smooth and free from ridges.
6 connection
E.3 Tracheal tUbe connectors may be provided with lugs, flats, or other
and disconnection, provided that any protrusions are well rounded'

8.4 A retaining or latching device may be incorporated into the

r to provide
aclded security of attachment of the conical connectors'

E.5 Any prolections (for example, hooks, lugs, or studs) s designed so as to minimize the risk
of catching on surgical dressings or other equipment. )

8.6 Tracheal tubes and tracheal tube materials used on tracheal tubes
n by commonly used concentrations of
under normal conditions of use should be res
anaesthetic vapours and gases.

dF

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 ISO 5361:2016(E)

Annex F
(informative)

Hazard identification for risk assessment

of this International
NOTE This list is not intended to be comprehensive for all devices within the scope r-^-L^^l r,.lra

F.1 Potential hazards associated with the placement, remova se of

tracheal tubes
lowing:
a) Trauma - mechanical or physiologic trauma to surrounding tissue
area, trachea,
l) minor abrasions, oedema, and inflammation (na
bronchus);

2) sore throat (temporary or prolonged);

3) bleeding or haematoma or both [na {c area, trachea, bronchus);

4) dental damage;

s) oedema, fibrosis, scar, paralysis, paresis,

y breathing);

6) infection [cellulitis, abscess, n"Jo\g,tt"]rnx, periglottic area, trachea, bronchus);

7) neuropathy, temporary on@Iry"Xnial or peripheral nerves;

8) arytenoid injury or didfutiog; ,l

e) sa liva ry cr"
"a
r{tfu\fnl mation;

10) epiglottic injurY;

11) lnJury pal spin'e or cord: paralysis, paresis, neuropathy;

burns perforation,
12) iulcers, web, necrosis, granuloma, scar, fibrosis, erosions,
st

,r$N-tation (vascular, oesophageal).

b) tnafuate oxygenation and/or ventilation resulting in hypoxia and/or hypercarbia due to the
follow{ng:

1l leakage ofrespiratory gases due to inadequate seal;

2) obstruction, kinking, foreign body, secretions;
3) bronchospasm, laryngospasm,stridor, hiccup, coughing, breath-holding;
4) pulmonary oedema [due to negative intrathoracic pressure in the presence of obstruction);
5) rebreathing due to excessive deadspace;
6) increasedworkofbreathing;
7) increased intrathoracic pressure;

reserved 33
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 -T-
,
ISO 5361:2016(E)
i
i

B) barotrauma leading to pneumothorax, emphysema;

9) endobronchial intubarion;

1-0) oesophageal intubation.

c) Aspiration or regurgitation due to the following:

1) inadequatecuffseal;
2) gastric insufflations, secondary to oesophageal ventiration;
3) inability to evacuate gastric contents secondary to obstruction by the tracheal
t
4) aspirationofdebris.
d) Toxicity:
1) allergy, including allergy to natural rubber latex;
2) tissuesensitivity; inflammation, necrosis;
3) systemic absorption of toxic substances.
e) Pollution:
1) leakage ofanaesthetic gases and vapours.

F.2 Potential device hazards

a) Failure or loss of the tracheal seal caused b

1l misplacement;
2) malposition of the head;
3l repositioning of the pati
4) loss of cuff seal pressure]
5) incorrect size;

10) inflation valve failure;

11) hole, rip or tear in shaft or cuff.
b) Loss of patency caused by the following:

1) malposirion of the head;

2) obstruction of the Iumen, debris, or fluid in the lumen;
3) cuff overinfration reading to tube narrowing or cuff herniation;
4) kinking;

34
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 ISO 5861:2016(E)

5) fracture of the shaft of the airway.

d Cuff overinflation caused by the following:

1) excessive manual inflation;

- 2) diffusion of nitrous oxide;
3) malposition of the airway;
4) failure of the inflating tube or valve.
d) Cuff underinflation caused by the following: ,{
1) undetected leak; ,.& \
2) sealing surface twisted or folded; A >
./1,\
3) failure of the inflating tube or valve; /
4) excessive resistance. Z
$
e) specitic patient caused by the rotto*i.f\'
Incorrect size for a specific rb,to*,.fi\
1) inadequate disclosure of size requirement, UVrynuf\gl
2) patientvariability.

$
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 ISO 5361:2016(E)

Annex G
[normativeJ
*Test method for tracheal seal

G.1 Principle
This test method is designed to determine the leakage rates at cuff pressures not 27 hPa
(27 cmH2O) for the minimum and maximum trachea diameters in which the designa tube
size is intended to be used. The performance information using this bench test to
provide a comparison of the sealing characteristics of tracheal tube cuffs on y setting
and is not configured or intended to predict performance in the clinical settinl

G.2 Apparatus
G.2.1 Transparent rylinders made of rigid material, having a to the sum of the distance
between the tip of tracheal tube under test and the math iFtracheal tube cuff plus a
minimum of 10 cm. The inside diameters of the transparent be equivalent to the maximum
and minimum diameters of the trachea in which the trachd test is intended for use.

G.2.2 Distilled or deionized (DI) watea ar body terdlqpEre

DZ "C to 39 "C), wirh a volume sufficient
to complete the test.

G.2.3 Analytical scale or mass balance, quantitation limit of 0,01

ryitile mini g.

G.2.4 Container to collect rna *.,rrrd.ffi"

G.2.4Containertocollect""o7@atleakspasttheinflatedcuff.
G'z..s Air pressure controt ana{ggyfuXvice, capable of indicating cuff inflation pressure between
0,0 hPa and 60 hPa (0 cmH2O to 6 ) with an accuracy of +2 o/o.

G.2.6 Timer/stopwa ntitation limit of 1 s.

G.2.7 A rninimufof 30\adfeal tubes of the same designated size (nominal inside diameterJ.

G.2,9 A graduated cuffinflation syringe.

G.3 Procedure
G'3'1 Perform the entire test at b.ody.temperature (37 "C to 39 'C). Assemble the
test apparatus using
-th,e. 1r11sRa-rent rylinder with an inside diameter that represents the maximum trachea diameter in
which ttre designated tracheal tube size is intended for use (see
Figure G.1)

G'3'2 Prepare the tracheal tube as described in the manufacturer's instructions

or any other substance is indicated to be applied to the cuff, for use. If a lubricant
report ttr. typ",-"n;;;;;t of additive

36
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 ISO 5361:2016(E)

applied. Position the tracheal tube under test inside the transparent rylinder (C.2.11 to a depth that
aligns the tip of the tracheal tube with the bottom edge of the transparent cylinder; thereby providing
a minimum of 10 cm distance between the machine end of the inflated cuff and the top edge of the
transparent cylinder. Inflate the cuff with air at the test inflation pressure no greater than 27 hPa
(27 cmH2O).

G.3.3 Condition the tracheal tube and transparent cylinder within a water bath maintained between
37'C and 39'C for 15 min to 30 min.

G.3.4 Suspend the transparent rylinder above the water collection container and analytical balance
'test cylinder.

G.3.5 Adjust the cuffpressure to the desired test pressure not to exceed 27 cmH2O). Record

G.3.6 Fill the transparent cylinder above the inflated cuff wit! I water at a temperature
of 37 "C to 39 'C to a water height of [5 + 0,5J cm above the point of the inflated cuff
and the transparent cylinder. Tare the liquid collection cham ming the test from this point.
Maintain this height of fluid throughout the test

G.3.7 After 10 min (T10), record the cuff of the water W10.

Calculate the volume of the water collected Calculate the rate of water leakage as
ml/h to a resolution of 0,1 ml/h.
NOTE The density of distilled or DI

G.3.8 Repeat the test in the rylinder using a minimum of 30 different h?cheal tube
samples marked with the

G.3.9 Repeat steps the transparent rylinder with an inside diameter that represents
the minimum trachea the designated Facheal tube is intended for use.

G.4 Ex

Prepare a fftat{eftlt includes the cuff inflation pressures P60 and Ps10, and the water leakage rate
from e4!r ftacheif trlbe under test of a given marked size, and the inside diameter (to 0,1 mm) of the
min{ytggltnum transparent cylinder that was used in each test [see 8.3.2 b)].
ExpresS{le result as the leakage rate range represented as the 50th and 90th percentile of tested
samplesQ)d minimum of 30 tracheal tubes,

@ ISO 2016 - All rights reserved 37

 ISO 5361:2016(E)

Key
L facheal tube
2 transparentcylinder
3 inflated cuff
4 liquid collection container
5 analytical balance
6 machine end of inflated cuff
7 liquid level [5 cm above machine.

i,il[1t***$
10 pressure-indicatins{$f
11 T-piece
Y

i:il:'$-eG1_
Tracheal seal testapparatus

38
@ ISO 2016 - All rights reserved
 ISO 5361:2016(E)

Annex H
(normative)

Test method to determine kink resistance

.
"ir,i
H.1 Principle
Tracheal tube resistance to kinking/collapse is tested by passing a steel ball t
tracheal tube while bending the tracheal tube 90" around a pre-defined radi

H.2 Apparatus
H.2.1 Kink resistance test apparatus
Fabricate a kink resistance test apparatus as depicted !n radius ofcurvature, R, that
corresponds to the size marking of the tracheal tube shown

Table H.1- Dimension ofcurvature

Designated tracheal tube size

ofcurvature' R
"I& A\Fdius
>8,0 mm lD , \ 50
rn -r,
>6,0 mm ID and <8,0 ) 40
>4,0 mm ID and <il mm IDV 30
>2,0 mm lD andkLi0n lD 25

H.2.2 Tra cheal tube u

H.2.3 Straps, to secure heal tube under test to the kink resistance test apparatus

NOTE Other ent reterition or attachment means can be used.

H.2.4 inimum diameter 75 7o of the designated size (nominal inside diameter) of the
trache 'sted.

ru cedure

H.3.1 Assemble the components of the apparatus as shown in Figure H.1. For cuffed tubes, position the
point of separation of the inflation tube against the apex of the radius of curvature of the test apparatus.
For uncuffed Facheal tubes, position the midpoint of the tracheal tube at the apex of the radius of
curvature of the test apparatus. Strap the tracheal tube to the kink resistance test apparatus securely
without compressing the tubing. The tracheal tube cuff, if provided, shall not be inflated during this test.

H3.2 Precondition the assembled test apparatus to (40 t 1J 'C and greater than 60 o/o relative humidity
[RH) for at least 6 h.

H.3.3 At the end of the conditioning period, check the patency of the lumen by dropping the steel ball
tH.2.4) through the lumen of the tube,

O ISO 2016 - All rights resened 39

.,,i
 ISO 536!:2Or6G)

H.4 Expression of results

Record whether or not the steer ba' passes freery through the
tube.

$
Key
I tracheal tube
Z sr.aps (2)
3 kink resistance test apparatus
4
R
steel ball
radius of curvafure

; -"."
{cv
,$ink resistance testapparatus
"

40
@ ISO 2016 - Att rights reserMed
 ISO 5361:2016(E)

BibliograPhY

laser surgery of upper airway

l.1l ISO/TR LL99L:[995, Guidance on airway management during

ISo 11990-1:20!1, Lasers and laser-related equipment Determination of laser resistance of

l;,21 -
tracheal tubes Part L: Tfacheal tube shaft
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IS0 11990-2:20L0, Lasers and laser-related equipment Determination of laser resistance of
[3] -
tracheal tubes Part 2: Tracheal tube cuffs
- _ marking and
L4l ISo 14408:2005, Tracheal tubes designed for laser Surgery
a c c o m p a ny i ng info r m a t io n

ISO 4135, ^An aesthetic and respiratory equipment Vocabulary

l.sI -
lEC 62366, Medical devices Application of usability
161 - {cuffed oral tracheal and
l;,.7) ANSI Z-79.16 1983, American National Standard for
nasal tracheal tubes for prolonged use
endotr bes. Respir. Care. 199e, 44 (6)
tBl farcon I.M., & DuRslI.l C.G. Special purpose
pp. 661-683

& DoRscs S.E. Understa resia Equipment, Sth edition, Wolters

1.91 DonscH I.A.,
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Kluwer/Lippincott Williams and wilki
Equipment, pp 561-628
i devices. Masui. 2006, 55 (1) pp. 5-12
[10] INoue T. Recentadvancesinai
Uanr\ilr oF rHE Dtrptculr AtnwRv' Anesthesiology' 2003'
1.111 ASA Pnec'rrce GuroeuxEs Fq[
e8pp.I26s-1277 a
l;,.Lzl DEAKER' r.w., nr"*oo(I@roN M., NewrH C.f. Cuffed endotrachealtubes in pediatric
intensive care. f. Perljtr' l|{+)€S (11 pp' 57-62

1.131 NewrH c.1,., nofr/F.;oFtr H.1r-n'r111'"T1",:Yf"t"{fed versus uncuffed endotracheal

-N.
tubes in pediatric care. f. Pediatr. 2004, L4+ pp' 333-337
young children during
l14l KHrrue ,np".i.6n of cuffed and uncuffed endotfcheal tubes in
nesthesiology. 1997, 86 (3) pp' 627-63L

F.l. The use of cuffed endotracheal tubes in infants and small

children'
l lsl
2001, 50 [6) pP.395-400
16l !, i-., DulleNropr A., GvstN C', DIt'lteR C'M" Gnnaen A'C' Shortcomings of cuffed
92 (l) pp'78-gB
l
liatric tracheal tubes. ai. I. en""tth' 2004,
cuffed and uncuffed tracheal tubes
l;,.L71 ASTM F1242 -96, Standard specification for
BnRuHenn W.N., Yosr L., TunNooRp H', DaruztcEn F Cuffed
tracheal tubes-physical and
t1B] pp' 36-4t
behavioral chaiacteristics. Anesth' Analg' L9B2' 6L (1)
-Related
[19lBrRruuRRpW.N.,YosrL.,fovrursD',Corneuts-S"TuRruoonpH'lntracuffpressuresin
endotracheaf tubes, cuff physical characteristics. Chest' L985' a7
pp.720-725 "nl't...t.oiio?nv
[,.201 McCoy wf., wses R.K. Accidental bronchial intubation, An analysis of AIMS
E.P., RussEl,L
incidenr reports from 198'8 to 7994 inclusive. Anaesthesia. 1997'
52 (1) pp. 24-3I
Scandinavia, supplementum
l;2L1 Lor"rHor,r N. A new tracheostomy tube, Acta Anaesthesiologica
XLIV- L97L:12-t3

41
@ ISO 2016 - All rights reserved
 ISO 5361:2016(E)

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1