Tiêu chuẩn iso 01135 3 2016

© ISO 2016 Transfusion equipment for medical use — Part 3 Blood taking sets for single use Matériel de transfusion à usage médical — Partie 3 Appareils non réutilisables pour prélèvement sanguin INTER[.]

Transfusion equipment for medical

Part 3:

Blood-taking sets for single use

Matérie l de tra sfusion à usage médical —

Partie 3: Ap ar ils n n ré tilisable s p ur prélèvement san uin

S con edition

2 16-1 -0

Refer ence n mb r

ISO 1 3 -3:2 16(E)

COPYRIGHT PROTECTED DOCUMENT

© ISO 2016, P blshed in Sw itz rlan

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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

the r eq eser

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F reword i v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 General r equirements 1

3.1 T ypes of set 1

3.2 Blo d taking as embly 2

3.3 A ir-outlet as embly 2

3.4 Ste i zation 3

3.5 Maintenanc of s e i ty 3

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 Botle ne dle 3

5.5 A ir-outlet ne dle 3

5.6 Blo d-taking ne dle 3

5.7 T ubing 4

5.8 Flow reg ulator 4

5.9 Pr ote tive ca s 4

6 Chemical r eq irements 4

6.1 Red cing (o idiza le) mate 4

6.2 Metal ions 4

6.3 Titr ation acidity or alkalnity 4

6.4 Resid e on ev poration 4

6.5 UV a sorption of ex tr act olution

5 7 Biolog ical r equirements 5

7.1 General 5

7.2 Ste i ty

5 7.3 Pyr og enicity 5

7.4 Haemolysis 5

7.5 To icity 5

8 Labeling 5

8.1 General 5

8.2 Unit containe 5

8.3 Shelf or multi-u it containe 6

9 Packag ing 6

10 Disposal 6

A nne x A (normative) Physical tests 7

A nne x B (normative) C emical tests 9

A nne x C (normative) Biolog ical tests 11

Biblog raphy 12

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 sponsible 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

For an ex lanation on the meaning of ISO spe ific t erms an ex r s ions r lated to conformity as es ment,

as wel as information a out ISO’s adhe enc to the Wor ld Trade Org nization (WTO) principles in the

Te h ical Bar ie s to Trade (TBT) se the folowing URL: www.iso.org/ iso/for word.html

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

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

This se on edition canc ls an r plac s the firs edition (ISO 1 3 -3:1 8 ), w hich has be n t ech icaly

r vised with the folowing chang es:

— part title has be n amen ed b “ or single use” in algnment with the othe p rt of ISO 1 3 ;

— f igur s ha e be n updat ed;

— subclause 3.6, “ Designation ex mples” has be n delet ed;

— phy sical, chemical an biolo ical r q ir ment have be n al gned with ISO 1 3 -4;

— Cla use 1 , “ Disp sal” has be n ad ed;

— Annex es A, Band Cha e be n algned with ISO 1 3 -4;

— al r fe enc s ha e be n updat ed

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 us e

— Part 4 : Tra s fus ion set fr s in le us e,gravit 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 3:

Blood-taking sets for sing le use

This p rt of ISO 1 3 spe if ies r q ir ment for ty es of blo d-taking set for medical use in orde

t o ensur functional int er hang ea i ity of trans usion eq ipment It is a plca le t o st eri z d blo

d-taking set int en ed for single use only

This part of ISO 1 3 also aims t o pro ide

a) spe ifications r lating to the q al ty an pe formanc of mate ials used in trans usion

eq ipment, an

b) a u ified pr sentation of t erms for such eq ipment

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 3 9 :1 8 , Wate fr a aly tic al la oratory us e — S ec ific ation a d tes t meth ds

ISO 7 64, Ste ie hypode mic ne dles fr s in le us e

ISO 1 6 7-1, Packa in fr te min lly s terili zed medic al dev ic es — Part 1: R eq ir ments fr mate ials,

s te ie b rrie sys tems a d p cka in sys tems

ISO 14644-1:2 1 , Clea ro ms a d as soc iated c ontroled env iro ments — Part 1: Clas s ific atio o air

clea lnes s b p rticle c onc entratio

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

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

3 General r equir ements

3.1 T ypes of sets

The blo d-taking set shal consis of the blo d-taking as embly an the air-outlet as embly, w hich ma

be sep rat e or combined

A dia ram of a ty ical blo d-taking set is i us rat ed in Figur 1

a) Blo d-taking as embly b) Air o tlet as embly

Key

Figure 1 — Examples of typical blo d-taking sets

3.2 Blood taking as embl y

The blo d-taking as embly shal consis of a blo d-taking ne dle for vein pu ctur an of a b t le

ne dle t o be inse t ed through one of the spe ified ar as pro ided on the b t le closur Each ne dle is

conne t ed t o one en of a length of tubing

3.3 A ir-outlet as embl y

The air-outlet as embly shal consis of an air f ilt er housing with air filt er combined with an air-outlet

ne dle for pie cing the spe if ied ar a pro ided on the b t leclosur

The f ilt er shal be ca a le of pr venting mic o ial ingr s

3.4 Ster il zation

The blo d-taking set shal be st eri e in it u it containe Evidenc of the efe tivenes of the st eri ization

proc s used shal be pro ided

3.5 Maintenanc e of steri ity

The blo d-taking set shal be pro ided with prot ective ca s designed t o maintain st eri ty of the

int ernal surfac of the set an the int ernal an ext ernal surfac sof the ne dles unti the set is used

The mat erials from w hich the blo d-taking set is made shal not ha e u desira le efe t on the blo d

p s ing through the set u de ordinary con itions of use, or on the fluids used in con e tion with the

blo d They shal not prod c any g ene al t oxic efe t or any local r action on the r cipient of the blo d

Ap ro riat e ty e t es s for as es ing biolo ical comp tibi ty ar given in An ex C

5.1 P ar ticulate c ontamination

The blo d-taking 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 blo d-taking 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 conne tions betwe n the comp nent of the blo d-taking 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 Bot le ne dle

5.4.1 T e b ttle ne dle shal not be les than 3 mm in leng th T e ex te nal diamete shal not be les

than 1,8 mm an the inte nal diamete shal not be les than 7 % of the ex te nal diamete

5.4.2 T e inte nal an ex te nal surfac s of the ne dle tube shal be clean an smo th

5.4.3 T e botle ne dle shal be desig ned in ac or danc with ISO 7 64 in or de to minimiz the n mbe

of rub e p rticles when the closur e ispier ced

5.5 A ir -outlet ne dle

The air-outlet ne dle shal ha e an int ernal diamet er not les than 0,7 mm, an ext ernal diamet er not

gr at er than 1,9 mm an a ne dle not ex ce ding 2 mm in length

5.6 Blood-taking ne dle

5.6.1 T e blo d taking ne dle shal not be les than 3 mm in leng th The exte nal diamete shal not

be g reate than 2 mm an the inte nal diamete shal not be les than 7 % of the ex te nal diamete

5.6.2 T e inte nal an exte nal surfac of the ne dle tube shal be clean an smo th The bevel of the

ne dle shal be sharpand fr ee from ridg es, bur s an b r bs

5.6.3 F r furthe r eq ir ement on ne dles, se ISO 9 2 , DIN 13 9 -4 and DIN 1 0 7-5

5.7 T ubing

The tubing shal ha e an int ernal diamet er of not les than 2,7 mm It shal not be les than 6 0 mm in

length The tubing shal be flexible an shal not ha e any kinks

5.8 Flow r eg ulator

5.8.1 T e flow r eg ulator shal be ca a le of adjus ing the flow of the blo d betwe n z r o an the

max imum

5.8.2 T e flow r eg ulator shal be ca a le of contin ous use thr oughout a donation without damag ing

the tubing T er e shal be no delete ious r eaction betwe n the flow r eg ulator and the tubing when s ored

in contact

5.8.3 F r furthe r eq ir ement on the flow r eg ulator, se ISO 85 6-14

5.9 Protecti ve caps

The prot ective ca s at the end of the blo d-taking set shal maintain the st eri ity or pr vent

contamination of the blo d-taking ne dle, the b t le ne dle an the int erior of the blo d-taking set

Prot ective ca 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

2 S

2 O

3 solution

[c (Na

2

S

2

O

3

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

1 , an of v lume of Na

2 S

2 O

3 solution for blank

solution, S

0

, shal not ex ce d 2,0 ml

6.2 Metal ions

The extract hal not contain in t otal mor than 1µg 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 show a sorb nc gr at er than 0,1

(o tical density)

7 Biolog ical requirements

The blo d-taking set shal not r lease any subs anc s w hich ma adve sely afe t the the a eutic

efe tivenes of the blo d ( e C.2)

7.2 Ster il ty

The blo d-taking set in it u it containe shal ha e be n subje t ed t o a v ldat ed st eri ization proc s

( e Biblo ra hy)

7.3 Pyrog enicity

The blo d-taking 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 blo d-taking set is fr e from p rog enicity Tes ing for p rog enicity shal be

car ied out in ac ordanc with Annex C

7.4 Ha mol ysis

The blo d-taking set shal be as es ed for fr edom from haemolytic cons ituent an the r sult shal

in icat e that the blo d-taking set is fr e from haemolytic r actions Guidanc on t es ing for haemolytic

cons ituent 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 Guidanc on t es ing for t oxicity is given in ISO 1 9 3-1

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 icat ed 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) thenameand ad r s of the man factur r;

b) desc iption of the cont ent ;

c) in ication that the blo d-taking set is st erie;

d) thelot (bat ch) designation;

e) year an month of ex iry;

f) in ication that he blo d-taking set isfor 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 an risk of air

emb lsm w hen used ina pro riat ely;

h) in ication that the blo d-taking set is fr e from p rog ens, or that the blo d-taking set is fr e from

bact erial en ot oxins

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 thiscase the information asr q ir d in this subclause shal

be given on the la el of the next bigg er shelf or multi-u it 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) thename and ad r s of the man factur r;

b) desc iption of the cont ent ;

c) in ication that he blo d-taking set ar st erie;

d) thelot (bat ch) designation;

e) year an month of ex iry;

f) ther commen ed st orag e con itions, if any;

g) then mbe of blo d-taking set

9 P ackag ing

9.1 The blo d-taking set shal be in ivid aly packed so that the sets r emain s e ie d ring s orag e

Packag ing shal folow ISO 1 6 7-1

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

9.2 The blo d-taking sets shal be p cked an s e i z d so that ther e ar e no flattened portions or kin s

when they ar e r eady for use

10 Disposal

Information for a se ur an environmental y soun disp sal of single-use blo d-taking set should

be given, e.g “Alway s disp se of blo d contaminat ed prod ct in a man e consist ent with es a lshed

biohazard proc d r s.”