Tiêu chuẩn iso 08536 13 2016

© ISO 2016 Infusion equipment for medical use — Part 13 Graduated flow regulators for single use with fluid contact Matériel de perfusion à usage médical — Partie 13 Régulateurs de débit gradués non r[.]

Infusion equipment for medical use —

Part 13:

Matérie l de pe f sion à usage médical —

Partie 13: Rég lateurs de dé it gradu s n n ré tilisable s a e co tact

à fluide

Fir t edition

2 16-1 -0

Refer ence n mb r

COPYRIGHT PROTECTED DOCUMENT

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F reword i v

1 Sc ope 1

2 Nor mati ve r eferenc es 1

3 Terms and definitions 1

4 Desig n 1

5 Materials 2

6 Physical requirements 2

6.1 Grad ated scale 2

6.2 Particulate contamination 2

6.3 Tensie s r eng th 2

6.4 Leakag e 3

6.5 Flow rates 3

7 Chemical r eq irements 3

8 Biolog ical r equirements 3

A nne x A (normative) Physical tests 4

Biblog raphy 6

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

ISO 8 3 consis s of the folowing part , u de the g ene al title In us io eq ipment fr medic al use:

— Part 1:In us io glas s b t les

— Part 2 Clos ur s fr in us io b ttles

— Part 3 : Aluminium c aps fr in us ion b t les

— Part 4 : In us ion set fr s in le us e, grav it y fe d

— Part 5: B ur tte in us io s ets fr s in le us e,grav it y fe d

— Part 6 : Fr eze dry in clos ur s fr in us io b t les

— Part 7: Ca s made o aluminium-plas tic s c ombin tio s fr in us io b t les

— Part 8: In us io s ets fr s in le us e w ith pr s s ur in us io a p ratus

— Part 9: Fluid lnes fr s in le us e w ith pr s s ur in us io eq ipment

— Part 10: Ac c es s ories fr fluid lnes fr s in le us e w ith pr s s ur in us io eq ipment

— Part 1 : In us io fite s fr s in le us e w ith pr s s ur in us io eq ipment

— Part 12 : Check v lves

— Part 13: Gradu ted flow r g lators f r s in le us e w ith fluid c ontac t

— Part 14 : Clamps a d flow r g lators fr tra s fus io a d in us io eq ipment w ith ut fluid c ontac t

Infusion equipment for medical use —

Part 13:

This part of ISO 8 3 spe ifies r q ir ment for non-st erie, single-use grad at ed flow r gulat ors used

as subcomponent in st eri iz d infusion set for single use t o control the flow of intra enous infusion

solutions with fluid contact u de gra ity fe d conditions

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 8 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 8 3 -4, In us io eq ipment fr medic al us e — Part 4 : In us io s ets fr s in le us e,grav it y fe d

ISO 1 9 3-1, B iolo ic al ev lu tio o medic al dev ic es — Part 1: Ev lu tio a d tes tin w ithin a ri sk

ma a ement proc es s

ISO 80 0 -4, Qu ntities a d u its — Part 4 : Mecha ic s

3 Terms and definitions

F or the purposes of this document, the folowing t ermsand definitions a ply

3.1

graduated flow re ulator

GFR

subcomp nent with grad ation an with fluid contact or set ing c rtain flow of lq ids

3.2

flow rate

v lume pe time

3.3

s ale

ar a of marks, t og ethe with any as ociat ed figuring, in r lation t o w hich the p sition of the p int er is

o se ved

4 Desig n

The GFR shal be designed for a cons ant flow r gulation The GFR shal be designed for a safe use t o

a oid ac idental chang e of flow rat e an shal clearly in icat e o en an of (closed)positions

A ty ical design for a GFR is shown in Figur 1

1 u stream

2 dow nstr eam

3 s ale

4 pointer

Figure 1 — Example for the design of a GFR (s hematic)

The mat erials used shal comply with the r q ir ment spe ified in Cla uses 6, 7 an 8 In ad ition, the

mat erials of al it ems desc ibed shal be as es ed t o the r q ir ment of ISO 1 9 3-1

6 Physical requirements

6.1 Graduated s ale

The scale shal give as minimum information o en an closed position of the GFR plus scale p sitions as

defined b the man factur r

6.2 Particulate c ontamination

The GFR shal be man factur d u de con itions that minimiz p rticulat e contamination The inne

surfac shal be smo th an clean When t est ed as spe if ied in A.1, the n mbe of particles shal not

ex ce d the contamination in ex

6.3 Tensi e streng th

When t est ed as spe ified in A.2, the GFR shal withs an a s atic longitu inal t ensie for e of not les

than 1 Nfor 1 s

6.4 Le kag e

6.4.1 T e GFR shal be tig ht in the “ Open ” an “Of” p sitions an al othe positions betwe n “ Open ”

and “ Of ” When tes ed as spe ified in A 3.2 an A 3.4, there shal be no leakag e

6.4.2 In the “ Of ” position, the GFR shal close the lne that ther e is no leakag e betwe n downstr eam

and ups r eam When tes ed as spe ified in A 3.3, ther e shal be no leakag e

6.5 Flow rates

The GFR shal del ve flow rat es ac ording t o scale set ings When t est ed as spe if ied in A.4, the GFR

shal delve this flow rat e as spe if ied b the man factur r within given t ole anc s

7 Chemical requirements

ISO 8 3 -4 a ples

8 Biolog ical requirements

ISO 8 3 -4 a ples

A nnex A

(normative)

A 1 Test for particulate c ontamination

Pe form the t es as spe if ied in ISO 85 6-4

A 2 Test for tensi e streng th

Ex ose the GFR t o bet est ed t o a s atic longitu inal t ensie for e of 1 N for 1 s Inspe t w hethe p int

of conne tion an comp nent withs an the t es for e a pled

A 3 Tests for leakag e

A 3.1 In the beg in ing of the test , con ition theGFR at the tes temperatur e

A 3.2 S t the GFR in “ Open ” p sition an con e t it with one en closed to a compr es ed air sup ly

Imme se the GFR , w ith one en blocked, in wate at (40 ± 1) °C an a ply air with an inte nal exc s

pr es ure of 5 k a to the GFR Inspe t the GFR for any leakag e of air in “Open ” p sition for 1 s Repeat

the tes at p sitions 2 %, 5 % an 7 % of scale

A 3.3 S t the GFR in “Of ” position an con e t one end to a compr es ed air sup ly an lea ve the othe

end o en Imme se the o en end ofthe GFR in wate at 40 ± 1) °C and a ply air with an inte nal exc s

pr es ure of 5 k a to the GFR for 15 s Inspe t the o en end of the GFR for any leakag e of air Finaly, close

the o en en of the tube; ke p the tes sample u de 5 k a pr es ur e an inspe t for any leakag e of air

coming fr om the GFR

A 3.4 Fi an infusion set with integ rated GFR w ith setting “Open ” p sition w ith degas ed, distiled

wate ; con e t it w ith it o ening ssealed to a v cu m devic an subje t it o an inte nal exc s pr es ure

of − 0 k a at 40 ±1)°Cfor 1 s Atmosphe ic pr es ure shal be the r efer enc pr es ure Exc s pr es ure,

in ac ordanc with ISO 80 0 -4, can as ume p sitive or negative v lues A sc rtain whethe air ente s

the infusion set Repeat his tes with GFR in position “Of” for anothe 1 s an contin e to do it at 2 %,

5 % and 75 % ofscale p sitionsfor the same time

A 4 Determination of flow rate

A 4.1 C n e t the GFR to an ex is ing g r a vity infusion set or use a g ra vity infusion set with GFR

integ rated an con ition at tes temperatur e (2 ± 2)°C

A 4.2 Pr ep r e a containe fi ed with sodium chloride solution [conc ntr ation (Na l) = 9 g /l at

(2 ±2)°C

A 4.3 Pr e-set the hydros atic pr es ure at 1m

A 4.4 Prime the g ra vity infusion set whie GFR is in “ Open ” p sition Tes the flow r ate in thr ee difer ent

p sitions ofthe scale:low, medium an high seting s

Measuring time shal be a pro riat e for the sele t ed flow rat es

The flow rat e ac uracy shal be ac ording t o the spe if ication of the man factur r

A 4.5 Pr ep re a containe w ith sodium chloride solution [conc ntr ation (Na l) = 9 g /l and a g r a vity

infusion set with GFR S t the GFR at a medial position Use a hydr os atic pr es ure of 1 m Start he tes

and ru for 1 min for s a i zation folowed b 6conse utive hours an r ead the v lume cole ted eve y

hour The s a i ty of flow r ate shal be at leas within ± 0 % d ring thetes time

Bibl og raphy

[1] ISO 1 3 (al p rt ), Tra s fus io eq ipment fr medic al us e