Tiêu chuẩn iso 15676 2016

INTERNATIONAL
STANDARD

ISO
15676
Second edition
2016-08-15

Cardiovascular implants and artificial
organs — Requirements for singleuse tubing packs for cardiopulmonary
bypass and extracorporeal membrane
oxygenation (ECMO)
Implants cardiovasculaires et organes artificiels — Exigences pour les

paquets de tubes à usage unique pour pontage cardiopulmonaire et
oxygénation des membranes extracorporelles

Reference number
ISO 15676:2016(E)
© ISO 2016


ISO 15676:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part o f this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country o f

the requester.

ISO copyright o ffice

Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47

www.iso.org

ii

© ISO 2016 – All rights reserved


ISO 15676:2016(E)

Contents

Page

Foreword ........................................................................................................................................................................................................................................ iv

Introduction .................................................................................................................................................................................................................................. v

1
2
3

4

Scope ................................................................................................................................................................................................................................. 1
Normative references ...................................................................................................................................................................................... 1
Terms and definitions ..................................................................................................................................................................................... 2

Requirements .......................................................................................................................................................................................................... 3

4.1
4. 2

4.3

5

5.1
5.2

5.4

S terility and no n- pyro genicity

4. 1 . 2

B io co mp atib ility

Phys ical characteris tics

General ........................................................................................................................................................................................................... 4
Biological characteristics ............................................................................................................................................................... 4

............................................................................................................................. 4
............................................................................................................................................................... 4
................................................................................................................................................................... 5
............................................................................................................................................ 5
5.3.2 Connections .......................................................................................................................................................................... 5
...................................................................................................................... 5
Performance characteristics........................................................................................................................................................ 5
5.4.1 Tubing life .............................................................................................................................................................................. 5
5.4.2 Spallation in tubing used in roller pumps .................................................................................................. 5
5.4.3 Shelf life ................................................................................................................................................................................... 6
5 .2 .1

S terility and no n- pyro genicity

5 .2 .2

B io co mp atib ility

Phys ical characteris tics
5 .3 .1

B lo o d p athway integrity

5 .3 .3

Tub ing material p ro p erty tes ting

Information supplied by the manufacturer ............................................................................................................................. 6

6.1

6.2
6.3

6.4

7

4. 1 . 1

Tests and measurements ............................................................................................................................................................................. 4

5 .3

6

Biological characteristics ............................................................................................................................................................... 3
............................................................................................................................. 3
............................................................................................................................................................... 3
................................................................................................................................................................... 3
4.2.1 General...................................................................................................................................................................................... 3
4.2.2 Dimensions ........................................................................................................................................................................... 3
4.2.3 Material properties ........................................................................................................................................................ 3
Performance characteristics........................................................................................................................................................ 3
4.3.1 Priming volume ................................................................................................................................................................. 3
4.3.2 Life to failure testing..................................................................................................................................................... 4
4.3.3 Spallation ................................................................................................................................................................................ 4
4.3.4 Shelf life ................................................................................................................................................................................... 4

Information on the tubing pack................................................................................................................................................ 6
6.1.1 Information on the unit container .................................................................................................................... 6

6.1.2 Information on the shipping container ........................................................................................................ 6
f
........................................................................................................... 7
f
f
........................................................ 7
f
f
........................................................................... 7
I n o rmatio n o n the acco mp anying do cuments

I n o rmatio n in the acco mp anying do cuments in a p ro minent

o rm

I n o rmatio n to b e p rovided by manu acturer up o n reques t

Packaging ..................................................................................................................................................................................................................... 7

Bibliography ................................................................................................................................................................................................................................ 8

© ISO 2016 – All rights reserved

iii


ISO 15676:2016(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work o f preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
di fferent types o f ISO documents should be noted. This document was dra fted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f
patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f
any patent rights identified during the development o f the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is in formation given for the convenience o f users and does not

constitute an endorsement.

For an explanation on the meaning o f ISO specific terms and expressions related to con formity assessment,

as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal system s.
This second edition cancels and replaces the first edition (ISO 15676:2005), which has been technically

revised.

iv

© ISO 2016 – All rights reserved


ISO 15676:2016(E)

Introduction

The intent of this document is to ensure that medical grade tubing in single-use tubing packs for the

tran s fer o f b lo o d and fluid du ri ng the p erio d o f c ard iopu l monar y byp a s s (C PB) and e xtracorp ore a l
membrane ox ygenation (E C M O) i s ade quately te s te d
provide s the s p e c i fic ation s

for

for

b o th s a fe ty and

fu nc tion .

T he u s er com mon ly

the tubi ng p ack. Fu r thermore, the pu rp o s e o f th i s do c u ment i s to en s u re

that the tubi ng p ack cha rac teri s tics b e appropriately d i s clo s e d i n the lab el l i ng a nd manu fac tu ri ng
i n formation p ackage . Tubi ng p er forma nce cha rac teri s tic s are s p e c i fic a l ly add re s s e d with i n the contex t

of this document as a component part of a single-use tubing pack.
This document therefore contains recommended procedures to evaluate such medical grade tubing
intended for use during CPB procedures and ECMO. Test procedures to determine the material
characteristics, the useful life of the tubing when used in a roller pump, and cleanliness are described.
T he l i m its

for

the s e cha rac teri s tic s are no t s p e ci fie d .

T h i s do c u ment a l s o i nclude s m i ni mu m rep or ti ng re qui rements . Re ady identi fic ation o f the p er formance

characteristics should assist the user in the selection of such medical grade tubing for the procedure

appropri ate to the p atient a nd pro ce du re . T h i s i n formation may b e u s e fu l i n a cl i n ic ’s qua l ity control
pro ce s s that a i m s to i mprove the s a fe ty o f C PB a nd E C M O pro ce dure s .

This document makes reference to other International Standards, which references methods for the
determination of characteristics common to medical devices.
Requirements for animal and clinical studies are not included in this document. Such studies, however,

may b e p ar t o f a ma nu fac turer ’s qua l ity s ys tem .

T h i s do c ument contai n s on ly tho s e re qu i rements th at are s p e ci fic to s uch me d ica l grade tubi ng

for

u s e du ri ng C PB and E C M O . Non- s p e c i fic re qu i rements are covere d b y re ference to o ther I nternationa l

Standards listed in the Normative References section.

© ISO 2016 – All rights reserved

v



INTERNATIONAL STANDARD

ISO 15676:2016(E)

Cardiovascular implants and artificial organs —
Requirements for single-use tubing packs for
cardiopulmonary bypass and extracorporeal membrane
oxygenation (ECMO)
1 Scope
T h i s do c u ment s p e c i fie s re qui rements
ex tracor p ore a l
i ntende d

for

membra ne

ox ygenation

for

s i ngle -u s e tubi ng p acks

(E C M O) .

T his

do c ument i s

for

c ard iopu l monar y b yp as s a nd

appl ic able

to

all

me d ic a l

tubi ng

c a rd iopu l monar y b yp as s (C PB) and/or e xtracor p ore a l membrane ox ygenation (E C MO) ,

but s p e c i fic re qu i rements and te s ts are i nclude d

for

tubi ng i ntende d

for

u s e with p eri s ta ltic pu mp s

du ri ng (shor t-term, i . e . < 6 h du ration) C PB s urger y or ( long-term, i . e . >2 4 h) E C M O pro ce du re s . T he
s teri l ity a nd non-p yro gen ic ity provi s ion s o f th i s do c ument are appl ic able to tubi ng p acks lab el le d a s

“sterile”.

T h i s do c u ment i s appl ic able on ly to the tubi ng a s p e c ts

for

mu lti func tiona l s ys tem s th at may have

i nte gra l comp onents s uch a s blo o d ga s excha ngers (ox ygenators) , re s er voi rs , blo o d fi lters , de fo a mers ,

blood pumps, etc.

2 Normative references
T he

fol lowi ng

do c u ments are re ferre d to i n the tex t i n s uch a way th at s ome or a l l o f thei r content

con s titute s re qu i rements o f th i s do c u ment. For date d re ference s , on ly the e d ition cite d appl ie s . For
u ndate d re ference s , the late s t e d ition o f the re ference d do c ument (i nclud i ng a ny amend ments) appl ie s .

ISO 34-1, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle

and crescent test pieces

ISO 527-1, Plastics — Determination of tensile properties — Part 1: General principles
ISO 9352, Plastics — Determination of resistance to wear by abrasive wheels
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process

ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 17665-1, Sterilization ofhealth care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices

ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,

validation and routine control of a sterilization process for medical devices

ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices

ISO 11137-2, Sterilization ofhealth care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,

sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
© ISO 2016 – All rights reserved

1

ISO 15676:2016(E)

ISO 14937, Sterilization ofhealth care products — General requirements for characterization ofa sterilizing

agent and the development, validation and routine control of a sterilization process for medical devices

ASTM D792-00, Standard test methods for density and specific gravity (relatively density) of plastics by

displacement

ASTM D2240-04, Standard test method for rubber property — Durometer hardness
3 Terms and definitions

For the purposes o f this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at />— IEC Electropedia: available at />3.1
durometer hardness

measure o f hardness o f elastic materials by Shore A range
3.2
elongation

increase in linear dimension
3.3
tensile strength

force per unit of original cross section on elongation (3.2) to rupture

3.4
tear strength

measure o f stress needed to continue rupturing a sheet o f rubber or plastic, usually a fter an initial cut
3.5
tubing pack

consists o f tubing sections joined by extracorporeal connectors and/or connected to extracorporeal

devices intended for CPB or ECMO applications
3.6
specific gravity

ratio o f the mass o f a body to the mass o f an equal volume o f water at 4 °C
3.7
spallation

phenomenon whereby particles dislodge from a sur face under cyclical stress
3.8
brittle point

temperature at which 50 % of test samples exhibit cracking or breakage after linear impact at a

specified speed

3.9
blood analogue

test solution which simulates blood viscosity between 2,0 × 10 −3 Pa·s (2,0 cP) to 5,0 × 10 −3 Pa·s (5,0 cP)
Note 1 to entry: The higher viscosity specified addresses conditions encountered during a range o f clinical

procedures specific to the tubing pack.

2

© ISO 2016 – All rights reserved


ISO 15676:2016(E)

4 Requirements
4.1 Biological characteristics
4.1.1

Sterility and non-pyrogenicity

The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance

with 5.2.1.

4.1.2

Biocompatibility

All parts o f the tubing pack that may come in direct contact with the patient’s blood pathway shall be

biocompatible with respect to their intended use.
Compliance shall be verified in accordance with 5.2.2.
4.2 Physical characteristics
4.2.1

General

When tested in accordance with 5.3.1 , the blood pathway shall not leak.
4.2.2

Dimensions

The dimensions of the tubing (e.g. inner diameter, wall thickness, segment lengths) shall conform to the

specifications o f the user.
4.2.3

Material properties

The tubing material shall be tested or specified by the manu facturer or extruder to determine that the
material properties listed in this subclause con form to the manu facturer’s specifications as reported

in 6.4 b). Upon request, the manufacturer should make them available in a technical data sheet. The
material properties include the following:
a) durometer hardness;
b) ultimate elongation;
c) tensile strength;
d) brittle point;
e) specific gravity;

f) tear strength.

4.3 Performance characteristics
4.3.1

Priming volume

The priming volume shall be measured or calculated and reported in 6.2 e). Results shall indicate the
performed according to the manufacturer’s protocol.

priming volume over the entire range o f tubing size provided by the manu facturer. Testing shall be
Some o f these tests may be combined and per formed at the same time.

© ISO 2016 – All rights reserved

3


ISO 15676:2016(E)

4.3.2

Life to failure testing

The labelled anticipated li fetime o f the roller pump boot tubing should be a figure not exceeding the
li fetime o f tubing as determined using the test specified in 5.4.1. The tubing shall be tested under the
operating variables specified by the manu facturer in 6.2 c) for each available size and wall thicknesses

of tubing. The results of these tests shall be reported as mean and standard deviation in 6.3 d).

4.3.3

Spallation

When tubing intended for use in a peristaltic pump is tested in accordance with 5.4.2, the spalled

particles shall not exceed the level specified by the manu facturer.
4.3.4

Shelf life

When tested in accordance with 5.4.3 , test results shall demonstrate the rated shel f li fe as specified by
the manufacturer.
5 Tests and measurements
5.1 General

Tests and measurements shall be performed with the device under test prepared according to
the manufacturer’s instructions for intended clinical use.
5.1.1

Operating variables shall be those specified by the manufacturer for intended clinical use, unless
otherwise specified.
5.1.2

According to the intended clinical use o f the tubing, the temperature o f test liquids shall be 4 °C,
30 °C and 39 °C, or other temperatures to reflect typical and extreme use conditions.
5.1.3

5.1.4

I f the relationship between variables is nonlinear, sufficient determinations shall be made to

permit valid interpolation between data points.

The test or measurement procedures are to be regarded as reference procedures. Other
procedures can be accepted provided that the alternative procedure has been shown to be of comparable

5.1.5

precision and reproducibility.

5.2 Biological characteristics
5.2.1

Sterility and non-pyrogenicity

Sterility and non-pyrogenicity shall be determined in accordance with the requirements o f ISO 17665-1,

ISO 11135, ISO 11137-1, ISO 11137-2 and ISO 14937, as applicable.
5.2.2

Biocompatibility

Biocompatibility shall be determined in accordance with the requirements o f ISO 10993-1 and
ISO 10993-11. I f the product is sterilized with ethylene oxide, biocompatibility shall also be tested in

accordance with the requirements of ISO 10993-7.

4

© ISO 2016 – All rights reserved


ISO 15676:2016(E)

5.3 Physical characteristics
5.3.1

Blood pathway integrity

5.3.1.1

The tes t s hall b e p er fo rmed at 3 7 °C with air o r water at the ap p ro p riate p res s ures . The tes t

5.3.1.2

S ub j ect the tub ing to a p o s itive p res s ure o f 1 , 5 times the manu facturer’ s rated p res s ure o r, i f no

shall be performed to ensure freedom from leaking.

maximum p res s ure is s p ecified, the tes t s hall b e p er fo rmed at 1 5 2 kPa
by the manu facturer

5.3.2

fo r

fo r

6 h o r as lo ng as it is s p ecified

clinical us e. Us ing air p res s ure decay o r vis ual ins p ectio n, check

fo r

leakage.

Connections

The connections shall withstand a pull force of 15 N for 15 s without separating. Testing shall be
p er forme d as s p e ci fie d i n the manu fac tu rer ’s pro to col .

5.3.3

Tubing material property testing

Tubi ng materi a l prop er ty te s ti ng sh a l l b e de term i ne d i n accordance with the re qui rements o f I S O 3 4 -1 ,

ISO 527-1, ISO 9352, ASTM D792-00, and ASTM D2240-04, as applicable or consistent with the
requirements of the end user.
5.4 Performance characteristics
5.4.1
5.4.1.1

Tubing life
The tes t liquid s hall b e a b lo o d analo gue to s imulate b lo o d vis co s ity.

The manufacturer shall conduct the test with a conventional dual-roller pump, reservoir,
f
f
diameter and wall thickness shall be tested. The operating variables of pump speed, back pressure, liquid
temperature, and method of setting pump occlusion shall be described, monitored and kept constant
over the course of the test.
5.4.1.2

tub ing, meas urement and co ntro l equip ment s p ecified by the manu acturer. Tub ing o

5.4.1.3
5.4.2
5.4.2.1

each internal

A failure is a leak in the tubing wall.
Spallation in tubing used in roller pumps
The tes t circuit s ho uld inco rp o rate two Y- co nnecto rs to acco mmo date a byp as s that includes a

fine filter to co llect p articles by circulating the entire tes t circuit vo lume in s uch a manner that all fluid is
diverted thro ugh the filter.

5.4.2.2

The tes t liquid s hall b e glycerine s o lutio n to s imulate b lo o d vis co s ity and the tes t s hall b e

co nducted at temp eratures intended

fo r

clinical us e, p re- filtered thro ugh a 5 µm filter.

5.4.2.3

The minimum vo lume o f fluid in the circuit s hall b e p rovided and actual vo lume co ntained at

5.4.2.4

The flow rate(s ) s hall b e rep o rted, s o that the vo lume/ho ur o f fluid co ntacting the tub ing wall

test onset shall be reported.

can b e es timated, as in accep ted metho ds

5.4.2.5

fo r

quanti fying wear deb ris generatio n.

The filter s ho uld b e removed at the ap p ro p riate time p o int (e. g. 1 h, 2 h, o r lo nger dep ending o n

s p ecific ap p licatio n s uch as C PB o r E C M O as des crib ed in

5.4.2.7) assuring that all the liquid contained in

the circuit has p as s ed thro ugh the filter at leas t o nce and a new filter ins erted

© ISO 2016 – All rights reserved

fo r

the next time p erio d.

5


ISO 15676:2016(E)

Removed filters s hall b e dried and weighed and values reco rded. I n this manner, there will b e minimal

volume depletion of the total circulating volume.

5.4.2.6 The manufacturer shall test tubing of each internal diameter and wall thickness with the test
equipment described in 5.4.1.2.
5.4.2.7

The circuit shall be run for 1 h intervals with the longest test lasting 6 h. For CPB, the circuit

s hall b e s amp led at 1 h, 2 h, 4 h, 6 h and

fo r

E C M O circuits , at leas t every 2 4 h therea fter

fo r

the length o f

time s p ecified by the manu facturer.

5.4.2.8 The cumulative mass of spall particles shall be reported in milligrams recovered for each
time point.
5.4.3

Shelf life

Us i ng a va l idate d me tho d , agei ng shou ld b e p er forme d on fi na l, fi n i s he d, s teri l i z e d, device s i n pri ma r y

packaging in order to determine nominal shelf life.

6 Information supplied by the manufacturer
6.1 Information on the tubing pack
6.1.1

Information on the unit container

The following shall be given on the unit container:
a) the manufacturer’s name and address;
b) the description of contents;
c) the model designation;
d)

the s tatement on s teri l ity and non-p yro gen ic ity;

e) the batch, lot or serial number designation;
f)

the s tatement “re ad i n s truc tion s b e fore u s e” or e qu iva lent s ymb ol;

g) the special handling or storage conditions;
h) the statement on single-use;
i)

the expi r y date .

6.1.2

Information on the shipping container

The following shall be provided on the shipping container:
a) the manufacturer’s name and address;
b) the description of contents, including number of units;
c) the model designation;
d)

the s tatement on s teri l ity and non-p yro gen ic ity;

e) the special handling, storage or unpacking instructions;
f) the batch, lot or serial number.
6

© ISO 2016 – All rights reserved


ISO 15676:2016(E)

6.2 Information on the accompanying documents
E ach s h ippi ng contai ner s ha l l contai n an “I n s truc tion s

for

u s e” le a fle t with the

fol lowi ng

i n formation:

a) the manufacturer’s address and telephone number (fax number and internet site address optional);

b) the model designation;
c) the operating instructions;
d)

the placement, typ e and s e c u ri ng o f tubi ng con ne c tion s;

e) the volume per length for all sizes of tubing;
f)

the pre s s u re l i m itation s

for

b lo o d p athways;

g) the statement that the following are available upon request:
1) sterilization method;
2)

l i s t o f the materi a l s o f the blo o d p athway.

6.3 Information in the accompanying documents in a prominent form
T he

fol lowi ng

i n formation s ha l l b e provide d i n a prom i nent

form

i n the accomp a nyi ng do c u ments:

a) the inner diameter and wall thickness;
b) the pressure limitations;
c)

the flow rate l i m itation s;

d) the expected life under manufacturer’s operating conditions, reported as mean and standard
deviation;
e)

the o ther device l i m itation s , e . g. materia l i ncomp atibi l ity with known volati le anae s the tic agents ,

solvents, or disinfectants.

6.4 Information to be provided by manufacturer upon request
T he

fol lowi ng

i n formation s ha l l b e provide d b y the manu fac tu rer up on re que s t:

a) the results of the testing conducted under 5.3.3;
4.2.3);
c) the spallation data.
b)

the phys ic a l cha rac teri s tic s (cite d i n

7 Packaging
Packagi ng s ha l l comply with the appropri ate re qu i rements o f I S O 1 16 0 7-1 and I S O 1 16 0 7-2 .

© ISO 2016 – All rights reserved

7


ISO 15676:2016(E)

Bibliography

[1]

ASTM D624-00e1, Standard test method for tear strength of conventional vulcanized rubber and

[2]
[3]

ASTM D638-03, Standard test method for tensile properties of plastics
B ah al S.M., & Rom ansky J.M. Spalling and sorption of tubing for peristaltic pumps. Pharm . Dev.
Technol. 2002, 7 (3) pp. 317–323
B arron D., H arbottle S., H oenich N.A., M orle y A.R., Appleton D., M cc abe J.F. Particle
spallation induced by blood pumps in hemodialysis tubing sets. Artif. Organ s. 1986 Jun, 10 (3)
pp. 226–235
B ommer J., P ernicka E., Kessler J., Ritz E. Reduction of silicone particle release during
haemodialysis. Proc. Eur. Dial. Tran splant A ssoc. Eur. Ren . A ssoc. 1985, 21 pp. 287–290
B riceno J.C., & Runge T.M. Tubing spallation in extracorporeal circuits. An in vitro study using
an electronic particle counter. Int. J. Artif. Organ s. 1992 Apr, 15 (4) pp. 222–228
C are y R.F., & H erm an B.A. The effects o f a glycerin-based blood analog on the testing of

bioprosthetic heart valves. J. Biomech . 1989, 22 (11-12) pp. 1185–1192
C oisne D. Quantitative assessment of regurgitant flow with total digital three-dimensional
reconstruction o f doppler flow in the convergent region: in vitro validation. J. Am . Soc.
Echocardiogr. 2002, 15 pp. 233–240
G ordon R.J., R avin M.B., Daicroff G.R. Cardiovascular Physiology For Anesthesiologists. Charles

[4]
[5]
[6]
[7]
[8]
[9]

thermoplastic elastomers

C. Thomas Publisher, Springfield, Ill, 1979, pp. 27–71.

[10] G ordon R.J., & R awitcscher R.E. Changes in arterial pressure, viscosity and resistance during
cardioplumonary bypass. J. Thorac. Cardiovasc. Surg. 1975, 69 pp. 552–561
[11] H oenich N.A., T hompson J., Varini E., M cc abe J., Appleton D. Particle spallation and
plasticizer (DEHP) release from extracorporeal circuit tubing materials. Int. J. Artif. Organ s.
1990 Jan, 13 (1) pp. 55–62
[12] Kim W.G., & Yoon C.J. Roller pump induced tubing wear of polyvinylchloride and silicone
rubber tubing: phase contrast and scanning electron microscopic studies. Artif. Organ s. 1998
Oct, 22 (10) pp. 892–897
[13] P eek G.J., T hompson A., Killer H.M., F irmin R.K. Spallation performance of extracorporeal
membrane oxygenation tubing. Perfusion . 2000 Sep, 15 (5) pp. 457–466
[14] R and P.W., L acombe E., H unt H.E. Viscosities of normal human blood under normal and
hypothermic conditions. J. Appl. Physiol. 1963, 19 pp. 117–122
[15] Robicsek F., M asters T.N., Niesluchowski W., Ye ager J.C., D unc an G.D. Vasomotor activity

during cardiopulmonary bypass. In: Pathophysiology and Techniques of Cardiopulmonary Bypass,
(Utle y J.R. ed.) . Williams & Wilkins, Baltimore, Vol. 2 , 1983, pp. 6.
[16] ISO 1183 (all parts), Plastics — Methods for determining the den sity of non-cellular plastics
[17] ISO 868, Plastics and ebonite — Determination of indentation hardness by mean s of a durometer
(Shore hardness)

8

© ISO 2016 – All rights reserved



ISO 15676:2 016(E)

ICS  11.040.40

Price based on 8 pages
© ISO 2016 – All rights reserved