BS EN ISO 10079-3:20f

lncorporating conigendum lune 2{. I

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Medi ment
Suctio
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* Part 3: wered from a
vacuum or po as source (lSO
10079-3:2014)
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 EUROPEANI STANDARD EN rSO 10079-3
i',
ii
NORME EUROPEENNE
L:.
'..:
EUROPAISCHE NORM May2074

t,
lcs 11.040.10 Supersedes EN lS@ trO079€:2.#S!

English Vension

Medical suction equipment - part 3: Suction eq

from a vacuum or positive pressure gas souq 79-
3:2O14)
::
I

Appareils d'aspiration m6dicale - partie 3: Appareils

d'aspiration alimentes par une source de vid'e ou de
gerate
YErqE - Tel'l
tdr 3'rt&'--
J- -r^" I

AbsawgefAte (l
pression (lSO I 0079-3:2014)

This European Standard was approved by CEN on 15 February 2014.

GEN members are bound to comply with the CEN/CENELEC lntemd

S:tandard 0re statrn of a national st-andard without any alteration. Up{ .-stipdaig the corxlitions for givirg thb
rebrenoes concernfu€ srdt
stanoards may be obtained on application to the CEN4ENELEC to any CEN rnember.
an Standanl exists in three official versions (English,
sporsibility of a CEN member into its own language
I'
srE[Lls as u]e official versiom.
lf{, ',
CEN members are the national standards bodies
#;, ptl""q, Former Yugoslav Republic of Macedonia
fiY l-u<embourg, Malta, Netherlands, Nonaay, poland, port
l{ngdom.

. .']

::'

is
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IY

CEIICENELEC Managemont Centre: Averxplfiornk lZ, B-l(XXl Brussels

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@ S014 CEN All rights of exploitation in any form ard by any .neans reseri,ed Ref, No. EH ISO l00n&gr2s1#fi
uorldwide for CEN national Members.
 BS EN ISO {0029€:2di4
EN lSO r0029-3:2014 (E)

Foreword
(
This document
)has rnittee tso/Tc 121
and respiratory borati vb' r' r v -2lS
SEN/TC I! "Res
anaesthetb equi of wh {

This European StanOar{_:F',b?

text or by endorsement,
nationat
{lu."n-t. status of a i*rer by
lat
at the latest by May 201t/.
the rate$t co
by Novernbe r 2D14, and onar sta

Attention is drawn to th$ Rossibilitg that some of the elements

of this document
rights. cEN [and/or cENlELrcl sn4lt not be hetd responsibte
for identifying any o
This document supersedes EN lS0 10079-3:2009.
This document has beNn prepared under a mandate
European Free Trade A$sociation, pnd supports essen

For relationship with EU Directi've,

$ee informative Annex ZA, wfrich part of this docusn,ent"
According to the CEN EN€LI=C Internal Regulations, the
organizations of thB fio&s
countries are bound to i tplemernt tfris European Standard: /
Croatia, Gp*'us, C:ffi
Republic, Denmark, Estr
Hungary, lceland, lrelan
France, Gennany, gwa
Noruray, Polamd,
Rornania, Slovakia, Slov
United Kingdom.

ISO 10079-3:2014 without any m

 ! hti't:lii4i i'is

..'

AS Ehl l$O {0079€:20'[4

EN l{i0 t0t}?9-3:201a (b-i1
t!
:1
rl
t,
Annex ZA {?
(informative)
iil
!t'i,
Relationship between this European Standard and the lE$sential :ii
Requirements of EU Directive 93/42/EEC .!

This European standlard has been prepared under a mandate given to cEN
and the European Frce Trade Association to provide a means of confonn
Directive 93l42lEEC.

once this standard is cited in the official Joumal of the European union u- that Directive and has
implerner*ed as a national standard in at least one Member State, the normative c{auses
this standard given in Table ZA.1 confers, within the lirnits of the standard, a presumption
conformity with the relevant Essential Requirements of that Directive.

NOTE lMen an Essential Requirement does not appear in TabtezA.l, ii stat it is not addrssed by
European Standard.

Table ZA.1 Conespondence between this Eu dard and Directivre 93I42IEEC

-.
Glause(s) / sub-
clause(slof this EN Qualifyin g rcmarks/notes

4.1,4.4,12t) covered
are no requirements for rn:rterials apart from
to perforna a dsk assessrnent and
disclose the presence of latex.
As these devices are only for errtracting body
toxicity and biological cornpatib,ililty is not
a risk.

4.1,4.2,5 Only the first part of this ER is col'ered

7.5.1 ,7 .5.2

4.1, 6.3, 6.5

Onlycovered as far as temperature is concerned

Onlycovered as far as stability is concemed
 ES EIS.ISO !@79-3:20i4
ffilffi {O0TB-E:2014{Ef

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12 b) 1$.4

12.
13.6a) q, fuilarS,W
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d)" o'g)' h)' j)'
ff,!|'
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13.6 W

13.64
12 b)" c$. r|}, h), j), v) 13.6 4
12 i| 13.6 h9
t24 13.6 i}
'r24 rs.6 q!

k
*^.*^ll9$_:1"_01*".tnrsand
trte smpe,of frlis
onrsB.t mqybe produr*(s! fdSWS
standard.

&
 ii
;',' : ";

tss ENllSO !00y9-3:2014

I$0 1O079-s:ZO1a(F!

Contents
Foneword...
t Scope a

2 Normative references
3 Termsand <lefinitions
4
4.L Riskrnanagement..,.........
4.2 Usability......

4.4 Biophysical or modelling research

5 Cleaning, dirsinfection and
6 Design requirements..............
6.1 Collection container
6.2 Connections....
6.3 Suction tubing......_....
6.4 Vacuum level indicators........,............,............,
6.5 Suppl'y connections
7 Operational requirements.....
7.I Ease of operation.-,.........
7.2 Disrnarntlingandreassembly..........
7.3 Mechanicalshock...,..........
7.4 Stabiljity..,.....
7.5 Protective devices.^............"....................:

7.7 Air leakage

B Physical reqruirements for field and
8.1 f*)Dintensions ..........,
8.2 Mass..
Performancr: level and flourate
9.1 High vacuum/h
"'*
9.2 Medium
7

10

11
11. of symbols
[L.2

12 Informationto be supplied bythe manufactuler,

Annex A (normativeJr Test methods
Annex B (informativ:) Rationale statement........^,,............
Annex C (informativeJ Lumen size and its effect on flowra&e

@ IS0 2014 - All rights reserved

ffiHrSWd :20t4
ffiHB or,*{E}

s $*pil of,suctilon _**_-E#

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 BS EN l5O 10079-3:201$:
Iso 10o79-3:20la(E|

Foreword

forstandardizationJ isaworldwide federation of national

,igT::*:i"p?1-:,l.lT,,E!.;il;;Ffiil;#;ffi
lt^or,[l".ll*tj:I?iil,9-.,g,1nization 'ilff:;HJfi sta
h""i,::f j: o,.
committee ::*::,' cr'i" _i " "
lT iT i!*.. :.hasra the
::fS, l, has been established ;d;-il;il;
right to ;;diJslil;;,
ffi
ffi.ift
ffiii;
nil, ##il
;H::,11
:.rJ;
,#;
non_gove.imentat, in liaiion with rso, atso
Interna
lJgrjlfii|llj:f_o1:.-1T"nt1l
o iTd
b,orates clos;ery with the I ntein ationar
rt in the
lf :o_tla EI ectrorechnica! matters
electrotechnical standirdization.
The procedures usecl to develop this document and
those i
in the Directives, parr 1. rn particulaithe
9:"::,1_"-d. llglrqc
different types of ISb' documents shoutd be noted. This needed for
docurnent ance with
editorial rules of the rtso/rEc Directives, partz(see www.iso.org/d
Attention is drawn tc, the possibility that some of the erements
patent rights. ISo sharil not- be herd responsibre ro.ia"ntirying may be the subject
anypatent rights identified during the development of the
, :hpatent rights. Details r
on the ISO list of paternt declaratio-ns received (s""
in the Introduction andy'
***.i,
Any trade name used in this document is information
constitute an endorsement. fhe convenience ofusers and does

For an explanation on
_the meaning of ISO sp expressions related to conform
assessment, as well as information
4boutlSO,s adl principles in the Technical Ba
to Trade [TBT) see thc'following U$L: Foreword
information
The committee responsible for this docu
L2l, Anaesthetic and respiratory
Subcommittee SC B, Snction devicesfor hos
cane ase.
This third edition cancels and replacBs the
revised. 0S0 10CI79-3:1999), which has been techn

IS0 10079 consists of the followi the general Eide Medical suction equipment:
Part 1 : Electrically, pow@d

Part 2: Manually p,owered nt

Part 3: Suction avacuum or positive pressure gas source
Anner A forms a is part of ISO L0079 while Annexes B. C and D are for i
only.

Annex B contains statemeqts for some ofthe requirernents of this part oflso 10079. The clau
and subclauses with an astenisk {*) after their number have correiponding rationale conta
in Anne- B. i addl
recom
uirements qfill not only facilitate the properapplication ofthis partof ISo
but t re\tisions.

@ IS0 2014 - All righrs reserved

&
 tss EN l5O 10079-3:201S
INTERNATIONAL STANDARD IS0 10079-3:2$!.a(Hft
ti!

fi
,{r

;,$

Medicatr suction equipment

Part 3:
q^-
Suction
Crrnlinn
equipment
lrr.,L,llrr|' cy
r, powere
ur l,rltgtl'L pl,,
^^rt!--as* wtul. s
pressure ga$ source

L Scope s
This part of ISO 10079 specifies safety and performance requ ical suction equiprnerg
powered frorn a vacuum or positive pressure gas soufioe nffri suction. tt apeffus tci
equipment connected to medical gas pipeline sJrstems or crilmd and uri attachments.
:ll'.^G-^+^- .
illustrates rL^
tuurLrdLcb rL-^^
Lue three
the parts
paf
L[r.ee ---!- -f t^^
rs oI
of
lAAd^
IJU IUUr'y
ISO L00Tgby
I
Dy provlol
providi
The equipment can be stand-alone or part ofan

Additional requirements for suction equipment i

this part of tSO 10079'.

not
This part of IS0 L0071, does not a
,t!

a) central power surpply (by va , piping systerns of vehides an$

buildings, and wall connector *
b) end-piece such as suction cat
c) syringes;
d) dental suction eqruipment; -$

e) s scaven4_in

tion; @
$
o fi
t
;
;]

,) ventouse (ob ic) equipment;

k) breastp I
I
l)l
m)u i;
n) plume tion, systems.

2 Normative references
The following documents, in whole or in part, are nor.mfit{ydy d in ttais docurment and atqr
indispensable for its application. For dated referenoe$i, wlty t*ue esiEion cited applies. Fbn undateS
references, the latest r-.dition of the referenced doeurnent ug any arnendrnents) applies,
,,
td

O IS0 2014 - All righs resrerved

 rih'.
.{i.t
{il

BS EN fSO 10079-3:2014
ISo 10O79-3:zO1a@) 1!'

ISO 3744, Acoustics

sound pressure
- Deterrnination of sound power levels and sound enetgy levetrs af noire
Engineeri,ng methodsfor an essentially freefield o*era reflecting plane
sorudrses

-
ISO 5356-1, /4 naesthetic and respiratory equipment Conical cownectsts Part 7: Canes and' sockffi
- - t

IS0 70001), Graphical symbols for use on equipment Registered. synfuds

-
ISO 14155, Clinical investigation of medical devicesforhuman subjeffi
-Gaod
ISO 1497t, Medical devices -- Application of risk managennentto mefriwil devices

IS0 15223-L , Medical device:s Symbols to be used with medical device hahels"
be supplied Part 7: General-requirements
-
ISO 80369 (all parts), Small'-bore connectors for liquids and gases fn
EC 6 0 60 1-1 : 2 0 0 5 +A L2, Me d[cal ctrical equipment Faft n : forsafery
I 1:2 0 e Ie
-
IEC 60601-1-6, Medical elect:rical equipment- PartT-6: Generul sofety and
p e rformance- Collateral stun dard : U sability
IEC 6L672-L, Electroacoustir:s Sound level meters Part L:
- -
IEC 62366, Medical devices -- Application of usability

For the purposes of this dor:ument, the folloWing

3.1
collection container
container in which liquids and solid p lected
2'' &'
ner qccarmhlw
nor asselmbly
er and its closu for suction

3.3
drainage
removal of liquid, solid particles or 6m body cavityonwound

3.4
end-piece
that part of the applied to the patient ryvhich laegins at the site where tu
drawn in and ends connection

Note 1to uspd end-pieces are a Yankausr sucker and a suctlon satheter.

3.5
exhaust port
opening through w xhaust gas is discharged

1l The n anhical symbol collections of trSO 7000, ISO 7001 and IS(} P&LS are aNso auailable on the Ool'ine
Platro rm-http ://wvvrv.iso.org,/obp.

2 @ lso zotq - All rtghtr

{
';li''''
1;;

WEfi$l{StS t, -3:20t{'i
ffi sdrsr.{-G&

3.6
field use i

use of suction eguiprnent in situations outside of the health rm sqfu nffin:,mff &fr
emergencres

3.7
filter
'device for retenfion o{'particulate matter

3.8
free airflowrate
rate of unrestricted fftrw of air through a designated inlet

3.9
highflowrate
free air flowrate of 20 l/min or rnone

3.10
high vacuum
vacuum level of50 kPa or rnore below atrnospheric pnessure

intermediate tubing
tubing between the colllection container and tt
3.13
intermittent vacrrunn
type of suction in which the negative pressu; tothe edrd@flmak' affid lll
returned to atrnospheric pressure
3.L4
ii
,l:

g
3,
T
{
;

3.16
medical gas pipeligr
;fystem l
complete system clh cornprises a supply systern, a riom ,and awd a
,j
tiCIfi
system with ter rnits at the points where medical gams,or trrE i

[SOURCE: IS definition 3.29]

3.r7

mbre than 20 kPa butless than 60 kPa below ik

3.18
outlet port
opening through which gas exits from the collection conhim{er

3.19
overfill protection device
device intended to preventliquid on solid particles from the

@ IS0 2014 - All rights resernad

BS EN l5O 10079-3:20'14
Iso 10079-3z2oL4(E)

3.20
single fault condition
condition in which a single tneans for protectiora against a safety hazard in equipmentis r#tyfeu&itr* {m.s
single external abnormal condition is presewt

Note 1 to entry: Maintenance c,f equipment is csnsidere

3.2L
suction
application ofvacuum to rernove liquid, solid parti

3.22
suction tubing
tubing for conduction of liquid, solid particles orgas
9.23
thoracic drainage
drainage of liquids and gas From the thoracic cavi
the patient

Note 1 to entry: For the purposes of this partof lS0 10S79, alt thoraci,cdrainqge is considered to be sfti1€.

3.24
transport use
use during patient transport outside ofa health cane
3.25
vacuumlevel
pressure less than atmospheric pressure

Note 1 to entry: In this part oflS0 10029, vacuunN a difrflerence frorn atrnospherk gtxrmae.

3.26
vacuum level indicator
device for displaying the vacuum I

3.27
vacuum source
component ofdevice for generati

3.28 ,o..
vacuum regulator
device for controlling the applied-

4 General
Suction equipment nts controlNed by electr,ical means, e"g" electronic timing, s&a[t wsr#t
the relevant reouir 60 50 1-1 :2005 +41-: 20 1 2"

4.L Risk

with suction bquipment po*,:red frorn a vacuurn or positive gas Jo*noe" R* blished riskrna
process shall be applied to the design of the device. The. risk nramagement process shall dap
following elements:'

risk analysis;

risk evaluation;

4 @ ISO Z0L4 -A$rlig@moorwd

 BS EW tsCI | :201{,;
rso !.s@79-sf0:[4fti$

f,
risk control;
-
production and p ost-production infornnation.
lt
fl
EXAMPLE IS014971. tj

Check compliance by'inspection of the risk rnanagementfile.

4.L.2 suction equipment powered from a vacuurn or positive pr

transported, stored, installed, operated in normal use and maintained
the manufacturel present no risks that are not teduced to an acceptable
procedures in accordance with Iso L497l and which are associated with,
normal and in single Fault condition.

NorE A situation in which a faultis notdetected is considereda norrnal co

situations might remain undetected over a period of time and, as a con :t hard tru an
risk. In that case, a subr;'equentdetected faultcondition needs to be con
siifgle f ault cund$n*on"
risk control measures to be deternnined within the risk rnanagem to deal nritll such
'eed
Check compliance by inspection of the risk management file.

4.L.3 Where requirements of this p 10079 freedom frorn unaoceptabil,e rtsl<"

a.cceptability or unacr:eptability of thia e detd fithe rnanufacturer in a r
their policy for deterrnining acceptable risk

Check compliance by inspection of the risk rnan

4.L.4 The manufacturer mayuse Brpe tests detailed within fhisparrofffi 1007
if an equivalent degrere of safety is obtained" methods shall be rralidated the
methods specified in r{nnexA of this part

Check compliance by inspection of the tech

4.2 Usabiliry

ance with IEC 50601-1-6 and IEC 64965, dne

From poorusability.
sability engineering file.

4.3 Clinicalinvesrtigil
Where
is claimed and in the risk management file. The clinical investigation shalfl mmn@ywdth
requirements of 55.

NOTE sourced from:

s) ofthe device concerned, or

cli fr5tion(s) or other studies reported in the ssientific literatune, of a similar f@r'
equiva the rlevice in question can be denaonstnate4 or

publish-ed and/or urnpriblished reports on other clinical experience of either the device in queshima ora
device for which equivalence to the device in question c"n be de*onstrated-

Check compliance by inspection of the risk management file"

,.
@ ISO 2014 - All rights resewed

'u
lft
 BS EN l5O 10079-3:2014
ISO 10079-3:20La(E)

4.4 Biophysical or modelling research

Where approp-riate, validatfrd biophysicalormodellingreseanch shaltheperforrned undertfu condit$orus
for which performance is clirimed and documented in th€ risk rnawagerrrent file"

Check compliance by inspection of the technical file.

5 Cleaning, disinfectiion and sterilization

rent which may be subject to co shall
and disinfected or sterilized as " This
ners.

Parts intended for re-use shall meet the requirements of Clauses Z af,Hr
those components have been submitted to 30 cycles of cleanireg and sterilization as
recommended by the manufacturer.

Check compliance by functional testing.

6 Design Fequirements

6.L Collectioncontainer

6.1.L General

The collection container shall clearly show the level

Check compliance by inspection.

6.1.2 Container capacity and usahle volume

6,L.2.L(*) Forsuctionerquipmenti for fleld use with werfilt protection" thd usable vcdume
of the collection container shrall be not I mt"
6+'2.2(*l For suction equipmifr ld use and whiah is intended to continue operatiqg
when the collection containei is fuU, the collection cgntalme!'shall be not less than 2f0S rul"
Check compliance by functioffi
6.L.2.gFor all other suction ' drng suctio
ding E {ntended for transport
tra use, tlne
usable volume of the collecticn coni be not less I and the container shall be fitte$
with overflow protec
Check compliance by nd the tests given in AZ.
6:1.3

The collecti fnOtimplode, crackorpernnanently and shall p.gs[flro rl'nrrir.ernrpmfe

t ilbt".idi i;; p-[]r*oo* creisre r 1 z 0 % of the
recommended rna vac'uum level, or 95 kPa below atrnosplnerfr-', wlnichever is less, for 5 rnin,
Containers intended for re'us;e shall be tested after 30 cycles
ofcleaming and disinfection or sterilizatiom
as recornmended by the manufacturer.
Check compliance by the tests given in A.3.

6
O ISO 2014 - All rights reservnd
 .,."1fr,'-':'^',1.'I;iii

BS EfU l5S tWT$-3;20[d$

ISO [0s?s-srg0i4(Ht

6.2 Connections;

6.Zi Tubing connectors for colNection containers

The connectors for the suction tubing and the intermediate tubing shall be designed to ."r#
assembly or clearly marked to indicate correct asse5nblylvhen all parts
".. -"I*d4 t
Check compliance b5r functional tesEingand inspection. i!
I
NOTE Incorrect connections have frequently been a cause ofspill orzer into rod n bssy$
suction. 'l
,.t

6.2.2 Inletport
The inside diameter of the suction tubing connector finlet port of
least 6mrn and the i,nside diameter of ttle suction tubing conneqg
Iarger than the inside diameter of the largest tubing size as
,,}

The inlet shall not be compatible with arqr conical connector s ISO S3S6-L or snmg-borE
-
connectors specified in ISO 80369 fall parts].
-$
S
by,functional
Check compliance

NOTE Because ofthe riskof misc inletportofthewf&ectfiranrsotain

should not be greater than 14 mrn.

6.2.3 Exhaust port t

It shall not be possible to connect suctionfubi aust port. {i'
Check compliance by functional testing '.,

6.3 Suction tubing i

6.3.1 shal
Suction tubing meter of not less than G mm. j;
The degree of collapr;e of thfs hall be less than 0,5 throughout its entire i:
Check compliance by the using the tubing specified by the manufaswrer nf$rc c,uctiq[3
equlpment. '
9.3,2!*) Suction t lied or recommended by the manufacturer" shatt foalre a mim,iirnu$f
length of 1,3 m. 'l
NOTE Suctio Formance may be markedly affected by the length and diarneter sftAe lnetnreen
collection contain f,end-piece, See,Annex C.

6.4 va
Sucti an operator-adiustable vacuum regulator; shall have a rmeamo sf g
atmospheric pressure at the patient end when attached to a s&Eti@m r,sd$e{:er

6.4,L The full scale of analog vacuum level indicators shall be not more than 20$ 9{r of Sse mtamii
vacuum level below artmospheric pressune as specified bythe manufacturer.

6.4.2 Analog displays shall have gradr.lations not less than 2 rnm apartt each grad
not more than 5 %o of'the full-scale value.

O ISO 2014 - All rights reserved

 BS EN l5O 10079-3:20'14
IS0lt 079-3:20La(E)

NOTE Movementofarotaryanalogvacuum level indicatorshouldhe anriclockwise fonan increase

level.
ia.rarwro.r

6-4.3 Digital displays shall display vacuum level below aunospheric pressure
at intenrrals of ao*
than 5 of the full-scale value.
a/o

6.t*"4 Vacuurn level indicatrf,rs on suction eouiDrnentinrFn.

uff_ Jlfl1T.l"^":l,i'1i.,1::: on sucrion equipment excepr as specified in6.4.4

! 5 0/o of the full-scale rralue.
within

6.4.6 Low vacuum equipn:nt shall be fitted with a vacuum level indicaton
and collection container.

Check compliance by inspection and functional testing.

6.5 Supply connections

Suction equipment powered by gas or vacuum shall:

if connected directly to the terminal medical be fitt€d witft a pru&n

complying with the relevant national

if connected remotelyto the terminal unitofa

systern or the outletofa
via a low-pressure hose assembly, the hose ar
with ISO 5359.
Check compliance by inspection.

NOTE Med-ical gas pipeline systems complying

pressure)- at a flowrate of 25 l/min.
tr supply vacuurn level of6$ kPe fahso{dBr
l/mln. Vacuum ieve!
level of
n 60 pressure) is the same as 4S kPa
atmospheric.

7 Operational requireme

7.L Ease of operation

The suction equipment sha

Check compliance by functional

7.2 Dismantling
Suction equipment in
dismantled by fo shall be desi
correct reassemblv indicate corre
accordance vre+r trii
y- antlingand
rer's instructions, tne sucuon equipment shail rnit the requirennenffi,ffi
Clause 9 as

7.3 Mechan
equipm_ent intended for field and
*::t:l
Deing dropped from a height
use shall enrs of Ctause g af&sr
o:[ 1 m onto or in the
If the suction equipment can be operated
equipment shall'be drop-tested -"Uoiu rrying case, individual parts of tfte sucbfim:
d. TG reassernbled suction equr.pment sh#l
meet the requirements given "r 9. as"
in Clause
Check compliance
by the tests given in AJ.
I
@ l5o 2014 - All rights reser*n4"nr
 85 E$J l5O t0079.3:20tfi
ffiO X.0O79-3:21O1

7.4 Stability
Su mentintendel f-,:ldl"d/o1t menrsgirren [n
as e, when placed l"j
on a surface of (

not intended for field use use shall meet requirernents

iiate, when placed in anypo CIfpg I D-slop{ tlrc
he manufacturer,

Check cornpliance by functional testing.

7.5 Protective deyices

7.5.1 Contamination protection

s
There shall be a means to prevent contamination of the +ra$,ils,rir

Check compliance by inspection. . ?Ti

'd
{:
,+.

7.5.2, Overfill protection devices

.c s.
When an overfill protection device is activated :;
eErd no naore than 5 nnl sf ftuid shaffi
pass downstream of the overfill protection device.
id

lf^t!9 oye.rfill protection device is integral with ; it,shall notactivate untilat

90 % ofthe stated capacity ofthe collection co reacfued-
Means to prevent foann passing downstream
sounne shall be provided.
Check compliance by the tests given in

7.5.3 Pressureprotection ,i,Y

'11:

7.5.3"L Negativeprcssune :;'.t

..:'i,
:

If a device to lirnit the maxi# is fitted, the dlall nnt exceed the set vacuura lr*4
by more than 10 o/0.
!t
.!
Check compliance by*Un ,y

#
a ptxitfue pren$ure at dae patientend clf more

Chec he tests given in AJ.

7.6
iX

7.6.1 Lowvacuum/lowflowrate equipment i

In normal use the maximum A-weighted :i
flowrate equipment, including
soun dyralueJ of lswyasuu
xce€d 60 dg-
"qriiprn"ntlor
Check compliance by the test given in A.g.

O ISO 2014 - All rights reserled

 BS EN ISO 10079-3:2O14
ISO 10079-3:201a(E)

7,6.2 Suction equipment; other than that specified in I"6'f

In normal use, the maximum A-weighted sound pnessure level **lpe) of suctiongqu
other than low vacuum/low flowrate equipnrent shall not ex

Check compliance by the tes:tgiven in A;f,. '

'i

7.7 Airleakage it

7.7.L Collection containers for general use

The maximum leakage into the collection container assernbly shail{ wcft 't&r*
collection container is intenrCed for use with suction equipment har,{nwa &.ee msre tha.s
1 l/min, the pressure increarse shall be less than 3,3 lipaTV in f,O q, me of Se
collection container in litres.

collection containers intended for re-use shall be tested after 3o and disinfectioneir
sterilization as recommende d by the manufacturer.
Check compliance by the tesits given in,A.9.1.

7.7 .2 Collection containe:rs for ttroracic drainage

The maximum leakage shall be no more than three

Collection containers intendred for re-use shall be of deaning and disinfectios.s'r

sterilization as recomrnended by the rnanufacturer.
Check compliance by the tests given in A.9.2.

8 Physical requireme;nts for field and tri uries eqrE* t

8.1 [*)Dimensions
Suction equipment intended for
rectangular opening having di
any carryiag &$e {tF franne" Sall pass thnough s
x 300 rnm.

ryOJE Suction equipment

define the dimensioni for suct
th resuscitation equipmnenf which may make it i so
In these circurnstances
llF thfrs subdause rnay notapply" but tfup
LrygBtwldttrlg,
mass and dimensions of all
for field use should be as maB as pmssibte.
Check compliance by

8.2 Mass
I

The mass of s ntended for field use, comple&e w,itle irs rarrytns case or frame awd
accessories,
kg.
I

NOTE
ofilen combined with resuscitation equiprmcmq r&ich may rnal<e l[
s
to define a equipment alone. In these circumstances thiisisum wary not,apply" uut au eq
intended for field usi
be as lightweight as possible.
Check compliance by functional
testing.

10
& nm jZ&'[+ - Alt nights.rcsurrm$
 tsS ENl5O l@I$-3:Zstffi
ISg 10$79-fi:eflfa{Sg

I'l
I

I Performance requiremenb forryacuurn level and flovrra.Ee

!1"
d.
,it;

,i-1
il
h
9.1 High vacuum/high flowrate equipnrent G
ix:
lli
;'f

Suction equipment nrarked "higtr vacuurn/high flor,rl" shall develop a vacuurn

of at least
ast 5{l
b$ kPa }relori&
atmospheric pressure within 10 s and a free ain flow into the. collection
tubing fitted) of not l,ess than 20 {min. {wlthoun s,uctR*fr

checkcompliance bythe testgiven inaJoatthe maxirnum and minimurn

by the manufacturer.

Pipelines conforming to ISo 7395-1 are required to have only

ry_OLE a fi's€ flow
25l/min.

9.2 Medium vacuum equipment

suction equipment marked "rnediurn vacuurn" shaH develop a etween 20 kPa aad d0
below atmospheric pressure, within 10 s.

f*ll.::tliancebyt,hetestgivenin.4.10,amhemaximumandminimumsupprypreosuree
by the manufacturer.

9.3 Low vacuum/low flowrate equiprnent

Suction equipment rnarked "low vacuuin/low
a vacuurn of not nlore tham Z0
below atmospheric pressure and a continuous
of less than 20 l/min aE the rmaxdwru
vacuum level setting recommended by ttre

Check compliance bythe testgiven inA.l1,

and minimum supplypressuFes
by the manufacturer.

9.4 Lowvacuum/high flowrate equipment

Suction equipment ma flow" shall produce a vacuurn of not sroire than ?O
atmospheric prr of not less than 2O tr/rnin at the seaximmrrn vacuu
P:l:y
level setting iecommended by

Check compliance by t in 4.11, at the maxirnum and rninirnum supply

recommended by thSpg
pressu

9.5 Thoracic drainage for adults

Suction equipme rrked "thoracic drainage" intended for use in adults shall :p,roduce a fnee
Itowrate of not le n 15 l/min at the inlet of the collection container.
The vacuum shall not exceed 10 kPa below atmospheric pressure.
t the level of vacuum to between 0 kpa and 10 kpa bel,ow atmosphenic
NOTE
nsthe vacuum leveldeveloped shouldnot below
for example broncho-pleural tistul4 a hig e.g. 25
and the ability .
higher vacuum levels and higher flowrates-is desirable.

marked "thoracic drainage" shal! be adjustable to a static vacuum level p'f Z kpa
lfflo*S*. Such equipme^1t sfrall produce a free air flowrate of ar leasr t5 n n-.-
be
fl:'j::lffIt:"q1:ss,ur9. LJ and
A[t[t s
Sn
be capable ora"vetooing, within
4,5 I total capacity.
5 s, 95 % of t'he servacuum r;t i;h;;;-";.;;lfi;;^ s,/srem

ll:liol.uguipment intended for thoracic drainage Shall not develop a pressure in excess f
patient tr flrpa at
inlet with a freer air flowrate of 10 l/min.

@ ISO 2014 - AII rights reserved

 BS EN ISO 10079-3:2014
ISO 10079-3:ZOL+(Ej

Check compliance by the tests in A.12.

9.6 Intermittent vacuum equipment

I

Suction equipment for intermittent vacuum- shall prodrrce a vacuurn le$e[ e t& 16 of rhe vacrrurm
hry#
specified by the manufacturer or t 10 0/o of the rnid-range.level if ttm Mnu T&H
cycling fre.quency shall be 'ithin 10 0/o of the specified frequency or ltl th if&s
range is adjustable.

Check compliance by the test in A.13.

9.7 Vacuum regulators with fixed setting

The vacuum level indicated shall not deviate by more than r 10 % frons f&e
All vacuum levels shall be expressed as the occluded (no-ftowJ value"
Check compliance by the tests giv€n in A,lt

Check compliance by the test in AJ6.

Suction equ
transportuseshallmeettherr,equirernents tmChusesfl
and I as ap to temperatures of -18 "C and +50 "ff"
Check complianbe b n inA.L7.Z.I and A_LT.2J,

10.2 Storage

l::'ll::: itp d/ortransportuse shall meetttrc requinenremlsgilr€nf;m Clanaserg

e"u;1, as
cted to temperatures of -40 "C and +60 oG
Check
tests given in A.122.3 and A"17.2.A.

11 Marking

11.1 Use of rymbols

Yitll*-t"d informationto
wnere appropriate symbols
be supplied by the manufacl.urer shall comp[y wirh EM amd
speiiried in ISo 7000 or Iso 1szz3-1.
as

12 @ffiCIp0$#-,swnffikf
 4l
r1;

85 EN l5O 10079-3:2014,
ISO 1OO79-3:zO1a(E!

,+

Check comPliance bY insPection' fi

:d

11.2 EquiPment .+ .,d,

f
The following information shall be permanently and legibly rnarked on the suction equiprnent,
or o$
parts of it, where aPPlicable:

a) the name or trade name and address of the manufactureran4 in ad d address

-
' ap '
representative where ap
the authorized representative

b) details necessary for the userr to identify

0 the word "sterile";
d) batch code preceded by the'word "LOT", or serial numbeq

e) an indication of the date by which the device, or parts

the year and month;

an indication that the device, or parts thereof, are for single acturer's irdication of
use shall be consistent);

g) words indicating "exhaust" on the exhaust port, il rg is provided. A single oPeni

may allow a misconnection and should be labelled; exhaust system is unlikelY to
misconnected;

h) words indicating "inlet" at the connection container, unless misconrrcction

prevented by a design feature;

D for collection containers having a or greatef,, the usable volume, expressed

millilitres, and graduations with i r 50 ml and not more than 250 ml;

all equipmentgenerating suction shall be with words indicating suction. This marking
be visible in the normal working position;
')
k) an indication thatthe equip for pharyngeal suction onlY;

u if the suction equ in the field and/or transport, it shall be marked on

equipment case as not su ambienttemperatures below...oC or above ..."C. If no
'at
is provided, the marked on the equipmeng

m) for suction equi thoracic drainage, words indicating "thoracic drainage";

n) the maximum vacuum which the equipment is designed shall be marked prominently
the display immed adjacent to it;

o) suction a vacuum fegulator with a variable control shall have a vacuum le

having-vircuum
indicator Fathe level on the inlet side of the vacuum regulator. The units
marlied prominently on the display case or immediately adiacent to i!
p) vacuum level indicator shall be legible to an operator having visual acui
y, olit iu"st 1,0, 1 m from the vacuuir level indicator at an ilhiminance of 215
mulated day-) light;
q) low vacuuffequipment with a vacuum level which is not adiustable by the shall be mark
-user I

either with the vacuum levr:l which can be attained or with wo ls indicating "low vacuum level";

intermittent suction equiprment shall be marked with words indicating "intermittent s

Equipment which can p-uid" both continuous and intermittent suction shall have the mode
clearly marked;

@ ISO 2014 - All rights reserved

 BS EN ISO 10079-3i2414
ISO 10079-3t201a(E)

s) if a progressive variation in the degree of vacuum level is available, the direction of adiustment tc
increase vacuum shall be clearly and permanently marked;

for suction equipment powered from a positive pressure gas source, which can be detactlbd frorm
---
the power source, the recommended maximum and minimum supplypr"rru*q

NOTE For medir:al g1s prpeline systems complying with ISo 7396, the positive press upplyisset
between 270kPa and550 kPa.

u) for suction equipment powered from a vacuum source the recommended

supply vacuum levr-'l;

v) for suction equipment powered by gas or vacuum, the maximum vacuum

NOTE If the suction r:quipment is comlbined with a resuscitatoD a single

sufficient for the combina.tion.

Check compliance by inspection.

11.3 Equipment or c:arrying case

The following information shall be permanently marked on rying case, or on the suction
equipmentwhen there is no carrying case.
/
The performance categoy (such as ,,high vacuum/high
vacuum", "low vacuurn/high
flow", "|ow vacuum/low flow", ,,intermitltent vacuum,,, ", or "thoracic drainage", as
appropriate) or the vacuum and flowrate ranges for
the marking visible in the norrnat
operating position.

Check compliance by inr;pection.

12 Information to be supplied by the

The manufacturer shall provide the followj nformation in the accompanying documents:
a) the name or trade hame and a
facturer and, in addition, the name and address of
the authorized representative

b) the intended purpose ofthe

c) a warning that the ld only be used bypersons who have received adequas
instructions in its use;

operational in all intended modes of operatiorg

.ent

L) rne tg,e ofj e.g. medircal suction, high vacuum, high

:, flow or
2) the flowrate olbtainable;
instructio
ling and reassembly of components, if applicable (see 7.2), including an
illustratio t parts irn theircorrect relationship;
s) that the user should carry out the manufacturer's recommended
:TIYt!i:"t
otsmantling and rea:;sembly -' test procedure after
"aih;;il,iip.."i f*" itii;-'-'
h) a specification
detail ing
U operating environment limits,

L4
@ ISO 2014 - All rights reserved
 * ''1'.
Try'-rF'w-
-_. _,. -.:,;ffi:;.:_::;*. :4

i
85 EN fSO 10079-3:2014;
IS0 10079-3:20!.a(E$

2) storage environment lirnits;

,.
the recommended metho-ds for cleaning and disinfection or sterilization of all reusa[le parts and ad
estimated life in terms of use cycles (see Clause 5); ''
$
,) suction equipment function test(s) which must b

k) size and type oftubing and connection to the col

if applicable;

r) useable volume of the collection container;

m) a list ofparts that can be replaced by the user, inc

n) details of the operation of arry overfill protection device fitted to olle container
and the usa.ble capacity of the collection container in all the r# ended inclined planes
operation;

o) method of ernptying the collection container and operation d w has occurred;

p) a- statement advising removal and servicing of the equipment i or solid has been.drawn int
the vacuum pump;

NOTE In sorne cases, this rnay require servicing by turer or his authorized agenL
q) if applicable,, a statement thert suction ceases

r)
s)
Yacuum tevel;

I disclosure o!. any component, .onr"ining' rubber latex;

u)

v) recornmendation for frequency of appnoved

w) fault-finding and
x) whether or not is suitable for use in an MRI environment;
y) any warnings and/or s to take;

O ISO 2014 - All rights reserved

 BS EN ISO 10079-3:2014
ISO 10079-3:201a(E)

AnnexA
[normative)
Test methods

A.l General
The apparatus and test methods specified in this annex
are not intended to
measuring devices or me^th"o^d_,s^which yierd resurtr ;;;;;;;cy"equat
to or sr* than specifid-
In case of dispute, the methods given in this parroilio
"f roozg ;ha, be the

A-2 Test for collection container usabre vorume, and

A.2.7 Devices with overfill pnotecfion
connect the overfiil protection device in accordance
to maximum free air flowrate. S".t
with t cturer's instructions" Set fl*l
:_q:ip3."l -"t". "t,oom
into the collection containen
. Note the water level. Rernsrre
the suction tubing from the water to
the volume ofwater which has passed the
allowliJ;;;i;; ffient for a further Z min. Measure
shut_off overfill device. Measure the volume
collected in the collection container at tt u iimu
tt u device is activated"
For re-usable suction equipmen! perform
the test a uipment has been subiected to 30 cycles
of cleaning and disinfeciion or steiilization as re& y the manufacturer.

4.2.2 Devices with no overfill protection (fie

room temperature. Operate the

meffi
f:T gly*er rernainingin the nden
operate the suction equipment until the graduated
cytlnder is emptied.

For.re-usable suction equip;

of cleaning and disinfection
h$test after the equipment ha_s been subjected to
30 cycles
as recommended bythe mirn rfacturer.

A.3 Test for conta strength

Place the collection
(if the equipment hr (i f p res ent) or the ompte te s uct ion equipmenr
:lg P""^,trl,:,T::^TltI_ c

If an inline ; .:o]!,Oi?l
mended,
container) in_ a protective encl'osu re, at20.C to 25 "C.
outlet port. A
attach the filter forihe test. Attach
tion container and accessories (if present) under
,ou.."u lo
","iur* ure
Lv qtt
manufactu test to Lzi % of tIrc
atmospheric TlIjTllT,"."cuum level or to a u"",r,r'n levei not ex.;;dl;;
is less. Hold the vacuum level for s min,
tng bels$ssiip,
procedure ana tri"n ."r-u"ll. Ii"p"rt tl*
possibte flyingdebris. be hazardous. Proper care should be taken
,rt#lt"l?:t-can to protect perconnel from,r

containers or re-usable filter assemblies, perform

the test after the equiprnernft.
cycles of cleaning and disinfection ;;e7of
sterilizatir ,, i".o**ended by the
",

@ ISO 2014 -Ail righS reserued

 implosion' cracking or permanent deformation
l::nT,j:t of rhe collest[on ,conra]iner and rhe filr*r

suction equiprnent for compliance with

the requiremenrs sirrnen
liflj?ij,f,le r-n otauses 7 amd g,

A suitable test apparutus is shown in FigureA.l.

2

Key
L vacuum source
2 vacuumlevelindicator
3 protective enclosure (loose fitting,
not seal
4 closedto atrnosphere
5 collection container unde,rb$

Figure A.l
- for testing collection containen strength

4.4 Testforr rur qrH, c sgt0r suction tubing

At 20 "C to 25 oC, .
il;;sh''llii."il, :"1**^:?i:'-lull l:Tg,t' and ptug one end rtri nFo.6.f ---- -ir now

tube is looselycoiled around a 100

mm diameterrylinder.
NOTE
rnay be cut in the cylinder to aid
calliper measurenrenL
Degree of ODinitil'ODtot
4..4=
IDlrrlti"t
PassA < 0,5

Fail A > 0,S

@ IsO 2014
- All rights reserved
L'f,
ias rN lso 1m79-328T4
;tSO fOOZg-322&

o
o

a) Eefore test
Key
1 vacuumsourqe
2 vacuumlevelindicatm
3 collectioncontainer
4 suction tubing
5 plug

degree of collapse for swtiw

4.5 Drop test

Drop the suction
f|oor in the
a height of 1 m onto a concrete Sws Ws
.nnolde,
the suction equipnnent
with the requirements given in Bas approprieue.

A:6 Test prot€ction in thoracic

Attach the
thoracic drainage system setup for raormal um fun wtdr &E
of 10 l/min, fsee Figure A.3) to a positive pressuFes(Nrrrnadjrmbxdltu a e
the pressure at that point.

@mrpfl4-dhm[&h.
 Dimensionsirn
I

x
alt
E
o
o
Key
I urce wit}r a flowna@ of 10l/min
2
3 suctiontube
4 droracicdrainagesystem

- Ilpical
Figure,A.3 apparatus fortesting
q ln thorac{cdnainage

4.7 Test for positive-pressune

$tlction s!r$te[Na$
with
port lT:fr,
uu€L uioe tsee tIEI&eAdJ. rb
NOTE A tdghgnessure reliefvalve maybe
Eest

@ ISO 2CI1{
- AH rirghts resened
1$
i eS eN FO 10079-3:20't4
!tso roozg-s:20!.a@)

ri
Dimensions in mil

Key
1 inlet
2 container (capacity 1 lto 2 l)
3 drivirg gas at manufacturer's recommended pressure
4 device under test
5 seal above exhaust port
6 exhaust enclosure, at least 100 mm clear ofventuri
7 onr/offvalve
8 outlet (atleast 100 % venturi exhaust cro

&
Figure A.4 Tlpical apparatus fo{
-

Noise test
Place the microphone of
-61672_11
specified in tEC
nd-level meter compl the s for a type I instrumemtr
rough the
position of maximum ssu horizontal plane passing
I suction equipment at a radius of 1 m" The rneasured sound pressure
lev, el sha[ not value.
For this tes
rent shall be operated
with the inlet port open to atrnosphere and with
the inlet
recom
its normal working range of florivrate, includingthe maxirnum flowrate
manufacturer. Measurements shall be taken using the frequency-weightdng
characteristic A
t time-weighting characteristic S on the sound-levefmeter. The rneasurernens
be taken in a free
over a reflecting plane as specified in ISO 3744.
background level of extraneous noise shall be atleast tr{} dB below thatmeasured dulrir4g
le$-weighted

@ ISO 2014 - Al! riglrts resorned

 BS SU 6'B 10079-3;20trs
tS0 79-3:z01afri}

:,

A.9 Test for air leakage from the collection container t

il
'4
lt
A.g.L Collection containers forgeneral use * ;iI

Evacuate the collecti inerto 40 mosphe

obse

NOTE collection codainers wlll usually have a pneumatic compliance of mvlKlla per nttF
volume.

Key
1

2
3
30 kPa and 50 NrPa elory ricpressure
4
5 closed to atmosphere
6 test collection conEiner
U
FigureA.S
- Tlpical testing leakage of collection fuEgeneral use

4.9.2 Collectionco f$tnorr"icdrainage

lose the on/offivalve. Set dte uecruurn negulator ig
ff valve and allow the tp reach the sri&
the bubbles. Calcula@ the of bubbles pEg
.i
jiBS EN l5O !0079-3:2014
llrso roozg-s:2o!a(E)
,{
I
$
{n

j i Dirmensions in ml"llimeaes

t
$

1 rracuum source
vacuum regulator
v:rcuurn level indicatol accurat€ to 2,5 o/o maxirnum scale value
ony'offvalve
component or system under test
closed to atnosphere
suction tube (6 mm inside diarnete[ square cut)
waterbottle

Figure A.6 Typical apparatus for testing leak lectionr €o$tainer for thoracic drainage
-

10Test for maximum vacuum ll ,ftee air {general suction equfi$F

&
a flow-measuring device
0,05 l/s oc/er the rangg_of
pneum in ser@
luipme htmanneF ml charnber (see Fflgune S.7 for a typical test setup]" Ope.rafre
suction equipment according to inufacturer's instructioors arnd record the flowrate.

@ lSO 2014 - All rights rsmrqtd

 BS EN ISO 1007H:20t4
rso 1007e-3*sra{s$
;,1

'li-
R

rii
q
{,

ci
,t
i(

t(ey x
1 flow measuring device
2 connecting piece (inside diameter 10 mrn to 20 rnrn and less tfoan I fth)
3 ctramber (100 ml)
4 -- length
diame@r 10 mm, length
ide diame@,r tubing as recommended bythe

Figure A.7 free air flowrate

-
Setup the suction equipmentwith a 2l col in place and, using a short tube, fit a vacuur&.a
level indicator to the container inlet occluding the inlet port. Operate the sucti'qi
equipmentfor notless than 10 s atthe ma
vacuum source as recommended bythe

All vacuurn level readings shall be e, ssed as the occluded {no-ftrow) value as shown on a rracartlm
indicator scaled 0 kPa to 100 kPa Elo spheric pnessure.
&
A.llTest for maximum v fuel and fuee air flowrate of low vacuum equip-
ment '
With the collection coi pty, switch on the,suction equipment with the vacuurn
adiusted to give the maxiil um. Occlude the inlet port to the collection container and nste
port and attach a low-resistance flowmeter ts it.
s are reached fsee Figure A.7).

ic drainage
t port of the equipment to a collecHon containerfs) to bring the totail
evacuated to 4,5 I r 0,1 l.

to the collection container(s).

With the vacuum regul.ator set to betwe en 6,6 kPa and 7,4 kPa below atmospheric pressure, swiEch
the suction equipment.

Note the time taken for the reading on the vacuum level indicator to increase frorn zero to 95 96 of
set vacuum level. Note the final vacuum level.

Openthe inletportand, using 2 m offlexible hose hav diameterofS mm, attach

seal having an inlet port of i0 mm inside diametec o that the end is 50 nnrn

@ ISO 2014 - Ail rights reserved

 ' l- '=:
I
-.1
I

5 EN fSO 1O079-3:2014
ISO 10079-3:2OM(E) Il

fr"
:;i

before the underwarer seat,a$. ,i,.

:S"ffi::,"il1H".F.,j:,:,??:jfHil:*.immerriatery

t Dimensjsns iu

I(ev
1 low-resistance flowmeter (<0,L kpa
at 25 l/min)
2 tubing of length Z m
3 equipment under test

Figure A.B Tlrpical apparatus for tesffnj

- fonthoracic drain4ge

4.13 Test for intermittent vacuum regula#

C_onnect the vacuum
regulator to a
to the inlet port mode a re e rnanufacturer. Setthe
::g{.lq
third of the g^ug" .in!u d;i;; the_ ,"on" time and- "off.
Ti-. -th_e_vacuurn
time i;
level in the
i;;pl;;
mrirfr.rsle

Open the suction. inlet

port and and "of,f" tirne in 5 cornplete cycles.

A.14Test for vacuum

fixed setting
A-7/d-1an---.

apahl g vacuurn leve

free of S0 l/min.
-'.urc A.yJ. qw uv - Ir nr-
vaur Lrn-. rruru€s ih;;"'?#'ile fies* {mae

414"2 proc,

,ressure.
or. lncrea
poftand
Repett the above
test three times. Report
the widest percentage deviation fnorn the fixed
setting.

@ l5O 2014 - All righrs remrnrod

 '$1'

ES EN ISO I0O79-S:ZO1#
ISO 10079-3:2CI1

A.15 Test for vacrlum re,gulator with variable se

Commence with the vacuurn source at g0 kpa below atmos
to 50 kPa below atrnospheric pressure with the vacuum
pressure or one-fifth of t res r is ilower"
pressure on the vacuum (se a , r,:

Set the vacuutn regulator to 55 kPa below

lower, and increase the vacuum level from
new occluded vacuum level pressure on the vacuu

Reduce the vacuum level from B0 kpa to 50 kpa bel

vacuum level pressure on the vacuum level indicat

Repeat the above test three times. Report the wide

2

Key
1 on,/offvalve
2 vacuumlevelindicator
3 vacuumregulatorundertest
atnospheric pres$rrq 50 [/ant$

apparatus for testing

A.16Test for ph

A.16.l TBstmaterial ail

4"16.1.1 vornitus
Prepare the
adding 100

NOT
benzoic acid may be added as a preserrnatirye-

A.16.1: ated cylinder

use graduated*cylinde4 having
a
a capacity of at least 300 ml with g s memore thamso rml aparfr
A.16A procedure

@ ISO 2014 - All rights reserved

 85 EN ISO 10079-3:201
tSO 1o079-3:201a(E)

frfl"Xtlli ;n.1ffi"iL"r'rTj;l;::** into thegraduated

ryrinderand record rtu

to environment of sucHon equipment

ffi;"Jl';ruesistance for field
""o;
A.L7.l General
Follo
with 1oi:1.1inofCfausJsil"ag,"r;pffii"d..
ntssiven
the procedures in A.17-2,tesr
the su*ion equ$

A:17.2 Procedure

A.17.2.1 Low temperature operation

" 'v quu /u 70' wl

equipment, 'u

4.17.2.2 High temperatune operation

Plene fha crrar-inr u^^,.:--^- . .
ll1;.:..:1"" _r: lgi gl g lS nt i n a n e nvi ron m^- c-, -r- - -
u ip
i*_l:t a temperaturg of (5b r zl
stabilized. At the end of tiris per[o&
€
::T gl"tl: fro; ;h; ;#ber
s u,cti on e q u ip me nt and nd ata tenaperature of betlnd--l-e6
Lljj.r^".9:la " 'ur"tru"iumil;;iiliw;n
the suction equipment.
40 % Ithin 5 rnin, start operating a

4.17.2.3 Low ternperature storage

PL17A.4 High

@ ISO ZO14 - AII righrs,reoermd