Tiêu chuẩn iso 01135 4 2015

© ISO 2015 Transfusion equipment for medical use — Part 4 Transfusion sets for single use, gravity feed Matériel de transfusion à usage médical — Partie 4 Appareils de transfusion non réutilisables à[.]

Transfusion equipment for medical

Part 4:

Transfusion sets for sing le use, g ravity

feed

Matérie l de tra sfusion à usage médical —

Partie 4 : Ap ar ils de tra sfusion n n ré tilisable s à alimentation p r

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 General r eq irements 2

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

3.2 Maintenanc of s e i ty 2

4 Materials 3

5 Physical requirements 3

5.1 Particulate contamination 3

5.2 Leakag e 3

5.3 Tensie s r eng th 3

5.4 Closure-piercing devic 3

5.5 T ubing 4

5.6 Fite for blo d an blo d comp nents 4

5.7 Drip chambe an drip tube 4

5.8 Flow r eg ulator 4

5.9 Flow r ate of blo d an blo d comp nent 4

5.1 Inje tion site 5

5.1 Male conical fitting 5

5.1 Pr ote tive ca s 5

6 Chemical r eq irements 5

6.1 Red cing (o idiza le) mate 5

6.2 Metal ions 5

6.3 Titration acidity or alkalnity 5

6.4 Resid e on ev poration 5

6.5 UV a sorption of ex tr act solution

5 7 Biolog ical r equirements 6

7.1 General 6

7.2 Ste i ty

6 7.3 Pyr og enicity 6

7.4 Haemolysis 6

7.5 To icity 6

7.6 A sses ment of blo d comp nent depletion 6

7.7 A sses ment of damag e to blo d comp nent 6

8 Labeling 7

8.1 General 7

8.2 Unit containe 7

8.3 Shelf or multi-u it containe 7

9 Packag ing 8

10 Disposal 8

A nne x A (normative) Physical tests 9

A nne x B (normative) C emical tests 13

A nne x C (normative) Biolog ical tests 15

Biblog raphy 16

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 sixth edition of ISO 1 3 -4, t og ethe with the firs edition of ISO 1 3 -5, canc ls an r plac s the

fifh edition (ISO 1 3 -4:2 1 ), w hich has be n t echnicaly r vised with the folowing chang es:

— the sco e has be n r s rict ed to gra ity fe d a plcations an the w hole document algned ac ordingly ;

— trans usion set for single use used in conjunction with pr s ur infusion a p ratus ar now

co e ed b ISO 1 3 -5;

— 3.3“ Designation ex mples” has be n delet ed;

— theNormative r fe enc s and the Biblo ra hy ha e be n updat ed;

— some minor edit orial chang es we e introd c d in the w hole document

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

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

— Part 4 : Tra s fus io s et fr s in le us e,grav it y fe d

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

Transfusion equipment for medical use —

Part 4:

Transfusion sets for sing le use, g ravity feed

This p rt of ISO 1 3 spe ifies r q ir ment for single use trans usion gra ity set for medical use in

orde t o ensur their compatibi ity with containe s for blo d an blo d comp nent as wel as with

intra enous eq ipment

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

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

component , an to ensur the comp tibi ty of set with a range of c lular an plasma blo d component

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 7 64, Ste ie hypode mic ne dles fr s in le use

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

1) To b r eplaced by ISO 8 369-7

3 General requirements

3.1 Nomenclature for c omponents of the transfusion set

The nomenclatur for component of trans usion set is given in Figur 1

Key

1 protective cap of the closur e-piercing device 9 injection site

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

Figure 1 — Example of a transfusion set

3.2 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

4 Materials

The mat erials from w hich the trans usion set given in Cla use 3 ar man factur d shal comply with the

r q ir ment spe ified in Cla use 5 If comp nent of the trans usion set come int o contact with blo d

an blo d comp nent , they shal ad itionaly comply with the r q ir ment spe ified in Cla uses 6 an 7

5.1 P ar ticulate 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

5.2 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

5.3 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

5.4 Closure-piercing devic e

5.4.1 T e dimensions of the closur e-pier cing devic shal conform to the dimensions show n in Fig ur e 2

NOTE T e dimension of 1 mm in Figure 2 is a reference me surement T e c os -section of the pier ing

device at his site is a cir le

Dimensions in milimetr es

Figure 2 — Dimensio s of the closure-pier ing device

5.4.2 T e closur e-pier cing devic shal be ca a le of pier cing an penetrating the closur e of a containe

for blo d an blo d comp nent without pr epier cing No coring should oc ur d ring this proc d r e

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

recommen ed to facilitat e its insertion into 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 t est eq ipment for penetration

for es b tween spikes an blo d b g ports have b en p blished S e R eferences [9] an [1 ]

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

5.4.3 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 force of 1 N for 1 s

5.4.4 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

5.5 T ubing

5.5.1 T e tubing , made of flex ible mate ial, shal be transp r ent or suficien y tr ansluc nt so that the

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

ected-to-normal vision

5.5.2 T e tubing from 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 pr ovided, an the male conical fiting

5.6 Fi ter for blood and blood c omponents

The trans usion set shal be pro ided with a f ilt er for blo d an blo d comp nent The f ilt 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 benot les than 80 % (mas fraction)of that

r tained on the r fe enc filt er

If the f ilt er has a conf irmed 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

5.7 Dr ip chamber and drip 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 between 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 f ilt 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

5.8 Flow r eg ulator

The flow r gulat or shal adjus the flow of the blo d an blo d comp nent between 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 he e is contact

5.9 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

5.10 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 ing dro of wat er

S t fitt ed with an elast ome ic bufe shal be designat ed “ not for use at pr s ur s a o e 2 k a aft er

pe forating the elast ome ic bufe ”

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

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

5.11 Male c onical fit ing

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

ISO 5 4- 2

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

5.12 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 fit ing, an the int erior of the trans usion set

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

6 Chemical requirements

6.1 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

[c (Na

2S

20

3) = 0,0 5 mol/l for the extract solution, S

1, and of v lume of Na

2S

20

3

solution for blank

solution, S

0, shal not ex ce d 2,0 ml

6.2 Metal ions

The extract shal not contain in t otal mor than 1 µg ml of b 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

6.3 Titration acidity or alkal nity

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

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

6.4 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

6.5 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

7 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 he trans usion set is fr e from p rog enicity Tes ing for p rog enicity shal be car ied

out in ac ordanc with An ex C

7.4 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 he 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

7.5 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

7.6 A sses ment of blood c omponent 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 ethrough the trans usion set

NOTE For 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 ;

— platelet concentrate: > 2,4 × 1 E

1

platelets per u it;

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

7.7 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 the set

)

The as es ment

should comp r using a v ldat ed t es method, samples of the blo d comp nent taken prior t o an aft er

pas ag e through the trans usion set

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:

3) In cou tries wher e h man blo d is not a vaila le for testing , eq ivalent est methods ma y b esta lished

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

+

)

— Platelet concentrate: Plat elet damag e – pH, swirling, h potonic shock response (HSR), morp olo y in e

u der p ase mic os op , su ernatant lactat e dehydro enase, P-selectin e pres ion (CD62P) on platelet

surface an su ernatant, Beta thromb glo ulin rele se

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

thrombin-antithrombin (T AT) complex es

The la el ng shal inclu e the r q ir ment as spe ified in 8.2 an 8.3 If gra hical symbols ar used,

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

NOTE T e presence of substances of interest can b in icated 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 int erest can b in icated by c os ing

the respective symb l

8.2 Unit c ontainer

The unit 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 ed 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 commen ed;

l) let e “ G”, which s an s for gra ity, an whose ty e height shal s an out clearly from

sur ou ding text

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 subcla use

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

8.3 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;