Tiêu chuẩn iso 01135 5 2015

© ISO 2015 Transfusion equipment for medical use — Part 5 Transfusion sets for single use with pressure infusion apparatus Matériel de transfusion à usage médical — Partie 5 Appareils de transfusion n[.]

Transfusion equipment for medical

Part 5:

Transfusion sets for sing le use with

Matérie l de tra sfusion à usage médical —

Partie 5: Ap ar ils de tra sfusion n n ré tilisable s a e le s a p r ils

de pe f sion sous pre ssion

Fir t edition

2 1 -1 -0

COPYRIGHT PROTECTED DOCUMENT

© ISO 201 , P blshed in Sw itz rlan

A ll rig hts r eserved Unles otherw ise spe ified, nopar of this p blc tion ma y be r epr od c d or utilz d otherw ise in an form

or b an me ns, ele tr onic or me hanic l, inclu in p oto opying , or postin on the internet or an intranet , w ithout prior

written permis ion Permis ion c n be req esed from either ISO at the ad r es below or ISO’s member bod y in the c u try of

F reword i v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms and definitio s 2

4 General r eq irements 2

4.1 Nomenclatur e for comp nent of the trans usion set 2

4.2 Maintenanc of s e i ty 3

5 Materials 3

6 Physical requirements 4

6.1 Particulate contamination 4

6.2 Leakag e 4

6.3 Tensie s r eng th 4

6.4 Closure-piercing devic 4

6.5 T ubing 5

6.6 Fite for blo d an blo d comp nents 5

6.7 Drip chambe an drip tube 5

6.8 Flow r eg ulator 5

6.9 Flow r ate of blo d an blo d comp nent 5

6.1 Inje tion site 6

6.1 Male conical fitting 6

6.1 Pr ote tive ca s 6

6.1 Storag e v lume 6

7 Chemical r eq irements 6

7.1 Red cing (o idiza le) mate 6

7.2 Metal ions 6

7.3 Titration acidity or alkalnity 6

7.4 Resid e on ev poration 6

7.5 UV a sorption of ex tr act solution 7

8 Biolog ical r equirements 7

8.1 General 7

8.2 Ste i ty 7

8.3 Pyr og enicity 7

8.4 Haemolysis 7

8.5 To icity 7

8.6 A sses ment of blo d comp nent depletion 7

8.7 A sses ment of damag e to blo d comp nent 7

9 Labeling 8

9.1 General 8

9.2 Unit containe 8

9.3 Shelf or multi-u it containe 9

10 Packag ing 9

11 Disposal 9

A nne x A (normative) Physical tests 10

A nne x B (normative) C emical tests 14

A nne x C (normative) Biolog ical tests 16

A nne x D (normative) Storag e v lume 17

ISO (he Int ernational Org nization for Stan ardization) is a worldwidefede ation of national s an ards

b dies (ISO membe b dies) The work of pr p ring Int ernational Stan ards is normaly car ied out

through ISO t ech ical committ ees Each membe b dy int er st ed in a subje t for w hich a t ech ical

committ ee has be n es a lshed has the right t o be r pr sent ed on that committ ee Int ernational

org nizations, g ove nmental an non-g ove nmental, in laison with ISO, also take part in the work

ISO cola orat es closely with the Int ernational Ele trot ech ical C mmis ion (IEC) on al matt ers of

ele trot ech ical s an ardization

The proc d r s used t o develo this document an those int en ed for it furthe maint enanc ar

desc ibed in the ISO/IEC Dir ctives, Part 1 In p rticular the dife ent a pro al c it eria ne ded for the

dife ent ty es of ISO document should be not ed This document was draft ed in ac ordanc with the

edit orial rules of the ISO/IEC Dir ctives, Part 2 ( e www.iso.org dir ctives)

A tt ention is drawn t o the p s ibi ity that some of the element of this document ma be the subje t of

p t ent right ISO shal not be held r sp nsible for identifying any or al such p t ent right Detais of

any p t ent right identified d ring the develo ment of the document wi be in the Introd ction an / r

on the ISO ls of p t ent de larations r c ived ( e www.iso.org p t ent )

Any trade name used in this document is information given for the convenienc of use s an does not

cons itut e an en orsement

F or an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lat ed t o conformity

as es ment, as wel as information a out ISO’ s adhe enc t o the WTO principles in the Te h ical

Bar ie s t o Trade (TBT) se the fol owing URL: F or word - Sup lementary information

The committ ee r sp nsible for this document is ISO/TC76, Tra s fus ion, in us io a d injec tion, a d blo d

proc es s in eq ipment fr medic al a d p armac eutic al us e

This firs edition of ISO 1 3 -5, t og ethe with ISO 1 3 -4, canc ls and r plac s ISO 1 3 -4:2 1 , w hich

has be n t ech ical y r vised with the folowing chang es:

— the sco e of ISO 1 3 -4 has be n r s rict ed t o gra ity fe d a plcations, w he eb , ISO 1 3 -5 is

focused on pr s ur infusion a plcations;

— a new Annex D on ‘St orag ev lume’ has be n ad ed

ISO 1 3 consis s of the folowing p rt , un e the g ene al title Tra s fus ion eq ipment fr medic al use:

— Part 3 : B lo d-takin s ets fr s in le us e

— Part 4 : Tra s fus io s ets fr s in le use,grav it y fe d

— Part 5: Tra s fus ion set fr s in le us e w ith pr s s ur in us io a p ratus

Transfusion equipment for medical use —

Part 5:

Transfusion sets for sing le use w ith pressure infusion

apparatus

Thisp rt of ISO 1 3 spe if ies r q ir ment for single use trans usion set for use with pr s ur infusion

eq ipment ca a le of g ene ating pr s ur s up t o 2 0 k a (2 b r) This Int ernational Stan ard ensur s

comp tibi ity with containe s for blo d an blo d component as wel as intra enous eq ipment

S con ary aims of this part of ISO 1 3 ar t o pro ide guidanc on spe ifications r lating t o the q alty

an pe formanc of mat erials used in trans usion set , t o pr sent designations for trans usion set

comp nent , an t o ensur the comp tibi ty of set with r d c l an plasma blo d comp nent

Plat elet component should not be trans used u de pr s ur using these set

In some cou tries, the national pharmaco oeia or othe national r gulations ar leg l y bin ing an

take pr c denc o e this part of ISO 1 3

2 Normati ve r eferences

The folowing document , in w hole or in p rt, ar normatively r fe enc d in this document an ar

in ispensa le for it a pl cation F or dat ed r fe enc s, only the edition cit ed a pl es F or u dat ed

r fe enc s, the lat es edition of the r fe enc d document ( inclu ing any amen ment )a pl es

ISO 5 4-1

1)

, Co ic al fit in s w ith a 6 % (L e ) ta e fr sy rin es, ne dles a d c ertain othe medic al

eq ipment — Part 1: G ene al r q ir ments

ISO 5 4- 2

1)

, Co ic al fit in s w ith 6 % (L e ) ta e fr sy rin es, ne dles a d c ertain othe medic al

eq ipment — Part 2 : L ck fit in s

ISO 3 9 , Wate fr a aly tic al la orator y us e — S ec ific atio a d tes t meth ds

ISO 3 2 -1:2 1 , Plas tic s c ola s ible c ontaine s fr h ma blo d a d blo d c omp nents — Part 1:

Co ventio al c ontaine s

ISO 3 2 - 2, Plas tic s c ola s ible c ontaine s fr h ma blo d a d blo d c omp nents — Part 2 : Gra hic al

sy mb l s fr use o la els a d ins truc tio leaflets

ISO 1 99 -1, B iolo ic al ev lu tio o medic al devic es — Part 1: Ev lu tio a d tes tin w ithin a ri sk

ma a ement proc es s

ISO 1 99 -4, Biolo ic al ev lu tio o medic al devices — Part 4 : Selec tio o tes ts fr inte ac tio s w ith blo d

ISO 14644-1, Clea ro ms a d as s oc iated c ontroled env iro ment — Part 1: Clas s ific atio o air clea lnes s

ISO 1 2 3-1, Medic al dev ic es — Sy mb ls to be us ed w ith medic al dev ic e la els,la el n a d inormatio to

be s up lied — Part 1: G ene al r q ir ments

F or the purposes of this document, the fol owing t erms and def initions a ply

NOTE These t erms an def initions are specif ical y ap lica le to An e D

3.1

fi lng v lume

V

F

v lume of tube d ring “ pr s ur les ” fil ing, r spe tively fil ng b gra ity

Not e 1t o entry: T e tub remains u stres ed

Not e 2t o entry: T e f iling volume is t o b eq ated with the calculat ed volume of the tub

S: V

S

= V

F+ V

tube ( fil ng volume, V

F)

Not e 1t o entry: For ilustration of the b lus volume, se Figure 1

4.1 Nomenclature for c omponents of the transfusion set

The nomenclatur for component of trans usion set is given in Figur 2

1 pr otective cap of the closure-pier cing device 8 flow r eg ulator

5 drip chamb r

a

In icates alternative locations of the filter for blo d

an blo d components Other desig ns ar e ac eptable,

if the same safety aspects ar e ensur ed

6 filter for blo d an blo d components

b

Injection site is optional

7 tubing

Figure 2 — Example of a transfusion set

4.2 Maintenanc e of steri ity

The trans usion set shal be pro ided with prot ective ca s t o maintain st eri ty of the int ernal p rt of

the set u ti the set is used

The mat erials from w hich the trans usion set given in Cla use 4 ar man factur d shal comply with the

r q ir ment spe ified in Cla use 6 If comp nent of the trans usion set come int o contact with blo d

an blo d comp nent , they shal ad itional y comply with the r q ir ment spe ified in Cla uses 7 an 8

6 Physical requirements

6.1 Particulate c ontamination

The trans usion set shal be man factur d u de con itions that minimiz p rticulat e contamination

Al p rt shal be smo th an clean at the fluid p thwa surfac s When t est ed as spe if ied in A.1, the

n mbe of p rticlesdet ect ed shal not ex ce d the contamination in ex lmit

6.2 Le kag e

The trans usion set, w hen t est ed in ac ordanc with A.2, shal show no signs of air leakag e

6.3 Tensi e streng th

Any con e tions betwe n the comp nent of the trans usion set, ex clu ing prot ective ca s, shal

withs an a s atic t ensie for e of not les than 1 Nfor 1 s

6.4 Closure-piercing devic e

6.4.1 T e dimensions of the closur e-piercing devic shal conform to the dimensions shown in Fig ure 3

NOTE The dimension of 1 mm in Figure 3 is a reference me surement T e c os -section of the pier ing

device at this site is a cir le

Dimensions in milimetres

Figure 3 — Dimensio s of the closure-pier ing device

6.4.2 T eclosure-piercing devic shal be ca a le of pier cing an penetr ating the closur e of a containe

for blo d an blo d comp nents without pr e-piercing No coring should oc ur d ring this pr oc d re

NOTE 1 A careful y controled surface tre tment of the closure-pier ing device (e.g siliconization) is

recommen ed to facilitate its insertion int o the blo d b g port The same efect can b achieved by a careful

selection of material for the closure-pier ing device T pical results inclu ing test eq ipment for penetration

for es b tween spikes an blo d b g ports have b en p blished S e R eferences [1 ] an [1 ]

NOTE 2 A central closure-pier ing device tip is prefer ed t o an asymmetric design in order to aid its insertion

6.4.3 When inse ted into a blo d b g port conforming to ISO 3 2 -1:20 3, the closur e-pier cing devic

shal r esis a pul for ce of 1 N for 1 s

6.4.4 When tes ed in ac ordanc with ISO 3 26-1:2 1 , 5.3, the con e tion betwe n the closur

e-pier cing devic and the blo d b g port hal show no evidenc of leakag e

6.5 T ubing

6.5.1 T e tubing , made of flex ible mate ial, shal be transp r ent or suficiently transluc nt so that the

inte fac of air an wate d ring the p s ag e of air bub les can be o se ved with normal or corr

ected-to-normal vision

6.5.2 T e tubing fr om the dis al en to the drip chambe shal be not les than 1 5 0 mm in leng th,

inclu ing the inje tion site, when provided, an the male conical fitting

6.5.3 T e tubing fr om the distal en to the drip chambe shal be ca a le of resis ing (w ithout

cola sing )negative pres ur es g enerated b the pr es ure infusion a p ratus

6.6 Fi ter for blood and blood c omponents

The trans usion set hal be pro ided with a f ilt er for blo d an blo d comp nent The filt er shal ha e

uniform p r s an shal co e a t otal ar a of not les than 1 cm

2

When t est ed in ac ordanc with

A.3

2)

, the mas of sol d mat erial r tained on the filt er shal be not les than 80 % (mas fraction)of that

r tained on the r fe enc f ilt er

If the f ilt er has a confirmed thr ad diamet er of (1 0 ± 1 ) µm an a p r siz of (2 0 ± 2 ) µm, with a

single warp an a single wef , a f iltration pe formanc t es can be ex empt ed

Por siz measur ment can be pe formed b mic osco ic inspe tion

6.7 Drip chamber and dr ip tube

The drip chambe shal pe mit contin ous o se v tion of the fal of dro s The lq id shal ent er the

drip chambe through a tube w hich proje t int o the chambe The e shal be a dis anc of not les

than 40 mm betwe n the en of the drip tube an the outlet of the chambe , or a dis anc of not les

than 2 mm betwe n the drip tube an the filt er for blo d an blo d component The wal of the drip

chambe shal not be close than 5 mm t o the en of the drip tube The drip tube shal be such that

2 dro s of dis i led wat er at (2 ± 2) °C an at a flow rat e of (5 ± 1 ) dro s /min delve (1 ± 0,1) ml

[(1 ± 0,1) g]

The drip chambe should pe mit an faci tat e the proc d r of priming

6.8 Flow reg ulator

The flow r gulat or shal adjus the flow of the blo d an blo d comp nent betwe n z ro and ma imum

The flow r gulat or should be ca a le of contin ous use throughout a trans usion without the tubing

being damag ed The e should be no delet erious r action betwe n the flow r gulat or an the tubing

w hen st or d in such a man e that the e is contact

6.9 Flow rate of blood and blood c omponents

The trans usion set shal del ve not les than 1 0 0ml of blo d at (2 ±2) °Cin 3 min with a pr s ur

6.10 Injection site

When pro ided, the self-sealng inje tion sit e shal r seal w hen t est ed in ac ordanc with A.4, an the e

shal be no leakag e of mor than one fal ng dro of wat er

Trans usion set for use with pr s ur infusion a p ratus shal not be f itt ed with an elast ome ic bufe

The inje tion sit e should be locat ed near the male conical f it ing

NOTE T e co-administration of drugs through the injection site is not permit ed in some cou tries

6.11 Male c onical fit ing

The dis al en of the tubing shal t erminat e in a male conical f it ing conforming with ISO 5 4-1 or

ISO 5 4- 2

Lue lock fit ingsin ac ordanc with ISO 5 4- 2 should be used

6.12 Protecti ve caps

The prot ective ca s at the en of the trans usion set shal maintain the st eri ity of the closur -pie cing

devic , the male conical f it ing, an the int erior of the trans usion set

Prot ective ca s should be se ur but easiy r mo a le

6.13 Storag e volume

The st orag e volume shal be s at ed ac ording t o 9.2 l) F or a def inition of the st orag e v lume an for a

t es method for the det ermination of the st orag e volume, se An ex D

7 Chemical requirements

7.1 Reducing (ox idizable) mat er

When t est ed in ac ordanc with B.2, the dife enc of v lume of Na

2S

20

3solution

1, an volume of Na

2S

20

3solution for blank solution,

S

0

, shal not ex ce d 2,0 ml

7.2 Metal ions

The extract shal not contain in t otal mor than 1 µg ml ofb rium, chromium, co pe , lead, an tin, an

not mor than 0,1µg ml of cadmium, w hen det ermined b at omic a sorption spe trosco y (AAS)or an

eq iv lent method

When t est ed in ac ordanc with B.3, the int ensity of the colour prod c d in the t es solution shal not

ex ce d that of the s andard mat ching solution containing (Pb

2+

)= 1 µg/ ml

7.3 Titration acidity or alkal nity

When t est ed in ac ordanc with B.4, not mor than 1ml of eithe s an ard volumetric solution shal be

r q ir d for the in icat or t o chang e t o the colour gr y

7.4 Residue on evaporation

When t est ed in ac ordanc with B.5, the t otal amou t of dry r sid e shal not ex ce d 5 mg

7.5 UV absorption of ex tract solution

When t est ed in ac ordanc with B.6, the extract solution, S

1, shal not how a sorption gr at er than 0,1

8 Biolog ical requirements

The trans usion set shal be as es ed for fr edom from p rog ens using a suita le t es an the r sult

shal in icat e that the trans usion set is fr efrom p rog enicity Tes ing for p rog enicity shal be car ied

out in ac ordanc with An ex C

8.4 Ha mol ysis

The trans usion set shal be as es ed for fr edom from haemolytic cons ituent an the r sult shal

in icat e that the trans usion set is fr e from haemolytic r actions

NOTE Guidance on testing for ha molytic constituents is given in ISO 1 9 3-4

8.5 Tox icity

Mat erials shal be as es ed for t oxicity b car ying out suita le t es s an the r sult of the t es s shal

in icat e fr edom from t oxicity

NOTE Guidance on testing for t oxicity is given in ISO 1 9 3-1

8.6 A sses ment of blood component depletion

S t shal be as es ed a ains the rang e of blo d component for w hich they ar r commen ed t o ensur

that no mor than 5 % of the r lev nt cons ituent (s) of a single ad lt the a eutic dose of each blo d

comp nent is r tained b the set

)

The as es ment should comp r samples of the blo d comp nent

taken prior t o an aft er p s ag e through the trans usion set

NOTE F or guidance, relevant constituents are ty icaly present in the fol owing doses or concentrations:

— red cel components: > 6 g ha mo lo in per u it;

— fresh frozen plasma: > ,7 IU F actor VI Ic per ml

8.7 A sses ment of damag e to blood c omponents

Trans usion set shal be as es ed a ains the rang e of blo d comp nent for w hich they ar

r commen ed t o ensur that the r lev nt cons ituent (s) of each blo d comp nent is not signif icantly

damag ed (or w he e a plca le, activ t ed or inactiv t ed) b p s ag e through theset

)

Dedicat ed trans usion set shal be ad itionaly as es ed a ains the pr s ur trans usion eq ipment

an prot ocols for w hich they ar r commen ed t o ensur that the r lev nt cons ituent (s) of each blo d

comp nent is not signif icantly damag ed (or w he e a plca le, activ t ed, or inactiv t ed) b p s ag e

through the set The as es ment should compar using a v l dat ed t es method, samples of the blo d

comp nent taken prior t o an aft er p s ag e through the trans usion set Spe if ic con itions such as

tubing, pump sy st em an eff iciency, ma imum pr s ur , an t empe atur mus be def ined

The clnical r lev nc of t es r sult should be det ermined b a compet ent ac r dit ed la orat ory

NOTE For guidance on suita le tests:

— R ed cel components: Ha molysis – su ernatant (fre )ha mo lo in an potas ium (K

+

)

— Fresh frozen plasma: Co gulation activation – prothrombin fra ment 1,2, f ibrinopeptide A, F actor XI a,

thrombin-antithrombin (T AT) complex es

The la el ng shal inclu e the r q ir ment as spe if ied in 9.2 and 9.3 If gra hical symb ls ar used,

then r fe t o ISO 3 2 - 2 and ISO 1 2 3-1

NOTE The presence of substances of interest can b in icat ed by using symb l 272 of ISO 70 0 by replacing

the “XX ” by the a breviation of the substance T e a sence of substances of interest can b in icated by c os ing

the respective symb l

9.2 Unit c ontainer

The u it containe shal be la eled at leas with the folowing information using the gra hical symb ls

in ac ordanc with ISO 1 2 3-1, w he e a pro riat e:

a) name an ad r s of the man factur r;

b) desc iption of the cont ent ;

c) in ication that the trans usion set is st erie;

d) lot (b t ch)designation;

e) year an month of ex iry;

f) in ication that the trans usion set is for single use only, or eq iv lent wording;

g) ins ructions for use, inclu ing warnings, e.g a out detached prot ective ca s;

h) in ication that the trans usion set is fr e from p rog ens, or that the trans usion set is fr e from

bact erial en ot oxins;

i) s at ement that 2 dro s of dis i led wat er delve ed b the drip tube ar eq iv lent t o (1 ± 0,1) ml

[(1 ± 0,1) g];

j) nominal dimensions of an intra enous ne dle, if inclu ed;

k) blo d comp nent (s) for w hich the set is r commended;

l) st orag e volume shal be la eled ac ording t o D.3 In case of dedicat ed trans usion set , the name

an ty e of pr s ur trans usion a paratusshal be ad itionaly given b the man factur r;

m) lett er “ P” , w hich s an s for pr s ur , and w hose ty e height shal s an out clearly from the

sur ou ding t ext

If the a ai a le sp c is t oo smal t o give al this information in legible charact ers an / r symb ls, the

information ma be r d c d t o d) an e) In this case, the information as r q ir d in this subclause

shal be given on the la el of the next bigg er shelf or multi-unit containe

9.3 Shelf or multi unit c ontainer

The shelf or multi-unit containe , w hen used, shal be la eled at leas with the folowing information

using the gra hical symb ls in ac ordanc with ISO 1 2 3-1, w he e a pro riat e:

a) name an ad r s of the man factur r;

b) desc iption of the cont ent ;

c) in ication that he trans usion set ar st erie;

d) lot (b t ch)designation;

e) year an month of ex iry;

f) r commen ed st orag econ itions, if any;

g) n mbe of trans usion set

10 P ackag ing

10.1 The trans usion set shal bein ivid aly p cked so that they remain s e ie d ring s orag e

The u it containe shal be sealed in a tamper-evident man e

10.2 The trans usion set shal be p cked an s e i z d in such a wa y that ther e ar e no flattened

p rtions or kinks when they ar e ready for use

11 Disposal

Information for a se ur an environmentaly sou d disposal of single-use trans usion set should be

given

E AMP E “Alway s dispose of blo d contaminated prod cts in a man er consistent with esta lished

biohazard proced res.”