Tiêu chuẩn iso 15675 2016

INTERNATIONAL
STANDARD

ISO
15675
Third edition
2016-08-15

Cardiovascular implants and artificial
organs — Cardiopulmonary bypass
systems — Arterial blood line filters
Implants cardiovasculaires et organes artificiels — Systèmes de
pontage cardio-pulmonaire — Filtres en ligne pour sang artériel

Reference number
ISO 15675:2016(E)
© ISO 2016


ISO 15675:2016(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 15675:2016(E)

Contents

Page

Foreword ........................................................................................................................................................................................................................................ iv
1
2
3

4

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

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

4.1
4.2

4.3

5

Tests and measurements to determine compliance with this document.................................................. 4

5.1
5.2
5.3

5.4

6

General ........................................................................................................................................................................................................... 4
Biological characteristics ............................................................................................................................................................... 4
5.2.1 Sterility and non-pyrogenicity ............................................................................................................................. 4
5.2.2 Biocompatibility ............................................................................................................................................................... 4
Physical characteristics ................................................................................................................................................................... 4
5.3.1 Blood pathway integrity (sterile final assembly) ................................................................................ 4
5.3.2 Blood volume ...................................................................................................................................................................... 5
5.3.3 Connectors ............................................................................................................................................................................ 5
Performance characteristics........................................................................................................................................................ 5
5.4.1 Blood cell damage ........................................................................................................................................................... 5

5.4.2 Filtration e fficiency........................................................................................................................................................ 6
5.4.3 Filter flow rate ................................................................................................................................................................... 6
5.4.4 Shelf life ................................................................................................................................................................................... 6
5.4.5 Air-handling capability............................................................................................................................................... 6

Information supplied by the manufacturer ............................................................................................................................. 7

6.1

6.2

6.3
6.4
7

Biological characteristics ............................................................................................................................................................... 3
4.1.1 Sterility and non-pyrogenicity ............................................................................................................................. 3
4.1.2 Biocompatibility ............................................................................................................................................................... 3
Physical characteristics ................................................................................................................................................................... 3
4.2.1 Blood pathway integrity ............................................................................................................................................ 3
4.2.2 Blood volume ...................................................................................................................................................................... 3
4.2.3 Connectors ............................................................................................................................................................................ 3
Performance characteristics........................................................................................................................................................ 3
4.3.1 Blood cell damage ........................................................................................................................................................... 3
4.3.2 Filtration e fficiency........................................................................................................................................................ 3
4.3.3 Flow rate capacity ........................................................................................................................................................... 4
4.3.4 Shelf life ................................................................................................................................................................................... 4
4.3.5 Air-handling capability............................................................................................................................................... 4

Information on the arterial blood line filter .................................................................................................................. 7

Information on the packaging.................................................................................................................................................... 7
6.2.1 Information on the unit container .................................................................................................................... 7
6.2.2 Information on the shipping container ........................................................................................................ 7
Information in the accompanying documents ............................................................................................................. 8
Information in the accompanying documents in a prominent form ........................................................ 8

Packaging ..................................................................................................................................................................................................................... 8

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2016 – All rights reserved

iii


ISO 15675:2016(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 third edition cancels and replaces the second edition (ISO 15675:2009), which has been technically

revised.

iv

© ISO 2016 – All rights reserved


INTERNATIONAL STANDARD

ISO 15675:2016(E)

Cardiovascular implants and artificial organs —
Cardiopulmonary bypass systems — Arterial blood line
filters
1 Scope
T h i s do c u ment s p e ci fie s re qui rements

for

s teri le, s i ngle -u s e, ar teri a l b lo o d l i ne fi lters i ntende d to fi lter

and remove emb ol i , debri s , blo o d clo ts and o ther p o tenti a l ly ha z ardou s s ol id and gas e ou s materia l

from

the b lo o d o f huma n s du ri ng c ard iopu l monar y b yp a s s s u rger y.

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 app l 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 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 2: Lock fittings
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-4, Biological evaluation ofmedical devices — Part 4: Selection oftests for interaction with blood
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 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 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 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
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
3 Terms and definitions
For the pu r p o s e s o f th i s do c u ment, the

fol lowi ng

term s and defi n ition s 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 />© ISO 2016 – All rights reserved

1

ISO 15675:2016(E)

3.1
arterial blood line filter
acce s s or y device u s e d as p a r t o f the c ard iopu l monar y b yp as s s ys tem i n the ar teria l blo o d re tu rn l i ne

for

fi lteri ng p a r ticle s s uch as blo o d clo ts , debri s a nd gas emb ol i

3.2
blood pathway

paths of the

arterial blood lin e filter

from

the blo o d

(3.1) containing blood during its intended clinical use

3.3
blood cell damage

loss or destruction of cellular components of the blood components
3.4
platelet reduction

percentage reduction of platelets contained in a circuit, as a function of time
3.5
plasma-free haemoglobin level

difference between the concentration of plasma-free haemoglobin in a circuit, as a function of time
3.5.1
normalized index of hemolysis
NIH

grams of plasma-free hemoglobin released after pumping 100 l of blood
NIH { g / 100 L} = ∆fHb × V × 100 − Hct ×
100

where
f

Δ Hb

V

Q
Hct
T

100

Q×T

is the increase of plasma free hemoglobin concentration (g/L) over the sampling time

interval;
is the circuit volume (L);
i s the flow rate (L/m i n) ;

is the hematocrit (%);
is the sampling time interval (min)

3.6
white blood cell reduction

percentage reduction of white blood cells contained in a circuit, as a function of time
3.7
filtration e fficiency
abi l ity o f the fi lter to remove p ar ticle s

percentage

from

the s i mu late d blo o d s u s p en s ion te s t fluid, expre s s e d as a

3.8
blood analogue
te s t s olution wh ich s i mu late s blo o d vi s co s ity b e twe en 2 , 0 × 10 −3 Pa· s (2 , 0 cP) , to 3 , 5 × 10 −3

Pa·s (3,5 cP)

3.9
bubble eliminator

device that can remove bubbles

2

© ISO 2016 – All rights reserved


ISO 15675:2016(E)

3.10
predicate arterial filter
s i m i lar a r teria l fi lter to the te s t ar teri a l fi lter th at h as previou s ly b e en approve d and u s e d

intended clinical use

for

the s a me

4 Requirements
4.1 Biological characteristics
4.1.1

Sterility and non-pyrogenicity

T he b lo o d p athway s h a l l b e s ter i le a nd no n- p yro gen ic . C o mp l i a nce s h a l l b e ver i fie d i n acco rd a nce

with 5.2.1.

4.1.2

Biocompatibility

T he p ar ts o f the b lo o d p athway s ha l l b e bio comp atible with re s p e c t to thei r i ntende d u s e . C ompl iance
sh a l l b e veri fie d i n accordance with

5.2.2.

4.2 Physical characteristics
4.2.1

Blood pathway integrity

When tested in accordance with 5.3.1
4.2.2

, the blo o d p athway sha l l no t le a k.

Blood volume

T he volu me o f the blo o d p athway s ha l l b e with i n the tolera nce s s p e ci fie d by the manu fac tu rer (s e e

4.2.3

6.3).

Connectors

C on ne c tors

for

conne c tion to the b lo o d p athway s ha l l, when te s te d i n accordance with

s e c u re con ne c tion . C on ne c tion

for

5.3.3, allow a

acce s s or y p or ts s ha l l me e t the re qu i rements o f I S O 5 9 4 -2 .

C on ne c to rs o f a typ e th at a l lows co n ne c tio n o f tub e s with a n i n s ide d ia me ter o f 4, 8 m m , 6 , 3 m m ,

NO TE 1

9, 5 m m or 1 2 ,7 m m , o r a typ e th at comp l ie s with I S O 8 6 3 7: 2 0 10 , Figu re 1 , or a typ e th at co mp l ie s with I S O 5 9 4 -2 ,
h ave b e en

NO TE 2

fo u nd

s ati s fac to r y.

C on ne c to rs cor re s p o nd i n g to I S O 8 6 3 7: 2 010 , Figu re 3 a re con s idere d a s o ne way to comp l y with th i s

requirement.

4.3 Performance characteristics

4.3.1

Blood cell damage

When determined in accordance with 5.4.1, the percentage change (positive or negative) of plasmaf
manufacturer.
fre e

haemo globi n, platele ts , a nd wh ite blo o d cel l s , s ha l l b e with i n the ra nge o

va lue s s p e c i fie d b y the

T he hemolys i s re s u lts s ha l l b e rep or te d a s mg/d L and N I H .

4.3.2

Filtration e fficiency

When tested in accordance with 5.4.2

, the fi ltration e fficienc y o f any i nd ividua l fi lter s ha l l b e at le a s t

8 0 % when te s te d with p a r ticle s th at are 2 0 % la rger tha n the nom i na l p ore s i z e o f the fi lter.

© ISO 2016 – All rights reserved

3


ISO 15675:2016(E)

4.3.3

Flow rate capacity

When tested in accordance with 5.4.3

,

te s t

re s u lts

wi l l

demon s trate

the

flow

rate

and

pre s s u re

l i m itation(s) to en s u re s a fe a nd e ffe c tive p er forma nce, a s s p e ci fie d b y the manu fac tu rer.

4.3.4

Shelf life

When tested in accordance with 5.4.4
the manufacturer.
4.3.5

, te s t re s u lts sha l l demon s trate the rate d shel f l i fe, a s s p e ci fie d b y

Air-handling capability

When tested in accordance with 5.4.5

, te s t re s u lts s ha l l demon s trate the ai r-ha nd l i ng c ap abi l ity, as

s p e c i fie d b y the ma nu fac turer.

5 Tests and measurements to determine compliance with this document
5.1 General
5.1.1

Tes ts and meas urements s hall b e p er fo rmed with the device in its terminally s terilized

5.1.2

O p erating variab les s hall b e tho s e s p ecified by the manu facturer

prepared according to the manufacturer’s instructions for intended clinical use.
fo r

fo rm

and

intended clinical us e, unles s

o therwis e s p ecified.

5.1.3

Unless otherwise stated, the temperature of test liquids shall be 37 °C ± 1 °C.

5.1.4

I f the relatio ns hip b etween variab les is no nlinear, s u fficient determinatio ns s hall b e made to

permit valid interpolation between data points.

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

5.2 Biological characteristics
5.2.1

Sterility and non-pyrogenicity

C ompl iance sha l l b e veri fie d b y i n s p e c tion o f the ma nu fac turer ’s do c u mentation on s teri l i z ation and
pyro gen te s ti ng , i n accordance with I S O 176 65 -1 , I S O 1 11 3 5 , I S O 111 3 7-1 , I S O 149 3 7 or I S O 10 9 9 3 -1 1 , as

applicable.

5.2.2

Biocompatibility

C ompl iance

sha l l

bio comp atibi l ity

be

for

veri fie d

by

te s t

or

by

i n s p e c tion

of

the

manu fac tu rer ’s

do c umentation

on

the fi n i she d device, i n accordance with I S O 10 9 9 3 -1 and I S O 10 9 9 3 -7, as appl ic able .

5.3 Physical characteristics
5.3.1

Blood pathway integrity (sterile final assembly)

Fi l l the blo o d p athway o f the device with water and s ubj e c t it to a p o s itive pre s s u re o f 1 , 5

×

the

manufacturer’s rated pressure or, if none is given, to a pressure of 152 kPa (22 psi) gauge and maintain
f
f
f
f
device for evidence of water leakage.
the pre s s u re

4

or 6 h or

or the i ntende d ti me o

u s e s p e c i fie d b y the manu ac tu rer. Vi s ua l ly i n s p e c t the

© ISO 2016 – All rights reserved


ISO 15675:2016(E)

5.3.2

Blood volume

The test liquid shall be anticoagulated whole blood or water.
The volume o f the blood pathway shall be determined as specified by the manu facturer.
5.3.3

Connectors

The connection shall be made in accordance with the manufacturer’s instructions for use.
The connection shall withstand a pull force of 15 N for 15 s without separating.
5.4 Performance characteristics
5.4.1
5.4.1.1

Blood cell damage
Test media

The test liquid for the blood pathway shall be heparinized blood.

5.4.1.2

Procedure

Two sets of appropriate, identical circuit components, including a pump, connecting tubing, a reservoir
exchanger, shall be assembled. The device under test shall be placed in one of the circuits. A predicate

(as specified by the manu facturer and o f suitable size relative to the device under test), and a heat
device shall be placed in the second test circuit. Priming and debubbling o f the circuits by recirculating
with an appropriate solution is recommended be fore blood is added. The blood pathway test-liquid

volumes shall, at the initiation of the test, be within 1 % of each other. Perform the test in vitro using
the conditions given in Table 1 . A su fficient number of paired tests should be performed to support a

statistical analysis. The predicate filter should be tested under the same conditions. Compliance shall
be verified by test or by inspection o f the manu facturer’s documentation on blood cell damage for the
finished device, in accordance with ISO 10993-4, as applicable.
Table 1 — Conditions for in vitro testing of blood cell damage
Item

Blood flow rate

Blood glucose
Haemoglobin

Level

Maximum variation

the manufacturer for intended

clinical use (see 6.3)
10 mmol/l
12 g/dl

±5 %

The maximum specified by

±5 mmol/l
±1 g/dl

The sampling schedule shall be in accordance with Table 2. More frequent sampling times are optional.
Table 2 — Sampling schedule
Time, after initiation of test
Parameter

Plasma-free haemoglobin
White blood cell
Platelets
Haemoglobin
Glucose
© ISO 2016 – All rights reserved

Prior to test

X
X
X
X
X

30

X
X
X
X

(min)

180

X
X
X
X

360

X
X
X
X

5


ISO 15675:2016(E)

Table 2 (continued)

Time, after initiation of test
Parameter

Activated clotting time
Temperature
Flow rates
5.4.2

5.4.2.1

Prior to test

X
X
X

30

(min)

X
X
X

180

X
X
X

360

X
X
X

Filtration e fficiency

Test liquid

T he te s t l iqu id s ha l l b e a glyceri n s olution or water. T he te s t l iquid sha l l conta i n 3 5 0 to 5 0 0 0 p a r ticle s
p er m l that a re 1 5 % to 2 5 % la rger tha n the nom i na l p ore s i z e o f the fi lter.

5.4.2.2

Procedure

Pass 500 ml of the test liquid at room temperature (20 °C to 22 °C) through the arterial blood line
fi lter at a flow rate o f no le s s than 10 0 m l/m i n a nd a pre s s u re no t exce e d i ng 1 5 2 kPa (2 2 p s i) gauge .

D e term i ne the pre - a nd p o s t-fi ltration me a n numb er o f p ar ticle s . T he te s t sh a l l b e p er forme d at the
ma nu fac tu rer ’s re com mende d flow rate s . C a lc u late the fi ltration e fficienc y, u s i ng the re ad i ngs
s i z e ra nge o f the te s t p ar ticle s u s e d
o f p ar ticle s

from

for e ach

from

the

te s t s a mple, b y s ub trac ti ng the p o s t-fi ltration me an nu mb er

the pre -fi ltration me a n, d ivid i ng the quo tient b y the pre -fi ltration me an nu mb er o f

p ar ticle s , a nd mu ltiplyi ng b y 10 0 to ob tai n a p ercentage .

5.4.3

5.4.3.1

Filter flow rate

Test liquid

The test liquid shall be anticoagulated whole blood or a blood analogue.
5.4.3.2

Procedure

Place the device u nder te s t i n an appropri ate te s t c i rc u it. S e t the flow rate at the ma xi mum rate d
flow and mon itor the i n le t and outle t pre s s u re s acro s s the fi lter

for

6 h . Me a s u re the flow rate u s i ng a

ca l ibrate d flowme ter. No te a ny pre s s u re cha nge s du ri ng the te s t.

If anticoagulated whole blood is used, this test shall not take into account the effects of formed elements
or proteinaceous aggregates.
5.4.4

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.
5.4.5
5.4.5.1

Air-handling capability
Test liquid

The test liquid shall be heparinized blood with a haemoglobin content of (12 ± 1) g/dl.
5.4.5.2

Procedure

Us e fi lter vent tubi ng a s s p e ci fie d i n the I F U. T he leng th and i nterna l d i ame ter o f the vent tubi ng s ha l l
b e s p e c i fie d . T he b ack pre s s u re at the ma xi mu m te s t flow sh a l l b e 2 6 , 6 kPa (3 ,9 p s i) ± 5 % . Us e a bubble

6

© ISO 2016 – All rights reserved


ISO 15675:2016(E)

eliminator to measure any air downstream o f the filter accumulated over a period o f 5 min from bolus
injection.
At flow rates o f 33 %, 67 %, and 100 % o f the specified maximum rated flow rate, 30 ml (for paediatric
or in fant arterial filter with a maximum flow rate o f less than 500 ml/min, the bolus shall be 2,5 ml
and for maximum flow rates higher than 500 ml/min, the bolus shall be increased by 2,5 ml for every
500 ml/min maximum flow rate; the maximum bolus shall be 10 ml) shall be injected as a single bolus.
Indication o f the air bolus injection point in the test circuit, rate o f injection, and type o f pump utilized

to circulate test liquid should be provided in the test protocol.
5.4.5.3

Test results

The results shall be reported as the percentage e fficiency o f gross air removal.

6 Information supplied by the manufacturer
6.1 In formation on the arterial blood line filter

The following in formation shall be given on the arterial blood line filter:
a) the manu facturer’s identity;

b) the model designation;

c) the direction o f blood flow.
6.2 Information on the packaging
6.2.1

Information on the unit container

The following shall be visible through or given on the unit container:
a) the manufacturer’s name and address;
b) the description of contents;
c) the model designation;
d) the statement on sterility and method o f sterilization and non-pyrogenicity;
e) the expiry date;

f) the batch, lot or serial number designation;
g) the words, “Read instructions be fore use” or equivalent symbol;
h) any special handling or storage conditions;

i) the statement on single-use.
6.2.2

Information on the shipping container

The following information shall appear 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 expiry date;

© ISO 2016 – All rights reserved

7


ISO 15675:2016(E)

e)

any s p e c i a l ha nd l i ng , s torage or u np acki ng i n s tr uc tion s .

6.3 Information in the accompanying documents
E ach shel f b ox sh a l l conta i n a n “I n s truc tion s

for

Us e” le a fle t with the

fol lowi ng

i n formation:

a) the manufacturer’s address and telephone or telefax numbers;
b) the model designation;
c)

the re qu i re d anci l l ar y e qu ipment;

d)

the i n s truc tion s on ne ce s s ar y, s p e ci a l or un ique pro ce dure s , a s appl icable;

e)

the d i re c tion s

f)

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

g)

the lo c ation and pur p o s e o f add itiona l entr y or exit p or ts;

for

pl aci ng the fi lter i n a s upp or t or op erationa l fi xtu re;

h) the priming procedure;
i)

the d i re c tion o f blo o d flow;

j)

the genera l op erati ng pro ce dure s

k)

the ai r-ha nd l i ng c ap abi l ity;

l)

the ma xi mu m and m i n i mu m re com mende d blo o d flow rate s;

for

norma l u s e;

m) the priming volume;
n) a statement that the following are available upon request:
1)

a l i s t o f materi a l s o f the b lo o d p athway;

2)

blo o d

p athway

pre s s u re

d rop

over

manufacturer;
3) data related to blood cell damage;
4) relevant tolerances for data presented;
o)

the

ra nge

of

b lo o d

flow

rate s

as

s p e ci fie d

by

the

the s tatement on s teri l ity, me tho d o f s teri l i z ation, a nd non-p yro gen ic ity.

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

fol lowi ng

i n formation s ha l l b e given i n accomp a nyi ng do c u ments i n a prom i nent

a)

the flow rate l i m itation s;

b)

o ther device l i m itation s ,

for

form:

example, materi a l i ncomp atibi l ity with known vol ati le anae s the tic

agents, solvents or disinfectants.

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 116 0 7-2 .

8

© ISO 2016 – All rights reserved


ISO 15675:2016(E)

Bibliography

[1]
[2]
[3]
[4]
[5]
[6]
[7]
[8]
[9]

ISO 7199, Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
ISO 8637:2010, Cardiovascular implants and extracorporeal systems — Haemodialysers,

haemodiafilters, haemofilters and haemoconcentrators
ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin
sensitization
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory
purposes
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and
in formation to be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and
in formation to be supplied — Part 2: Symbol development, selection and validation
ISO/TS 23810, Cardiovascular implants and artificial organs — Checklist for preoperative
extracorporeal circulation equipment setup
ANSI/AAMI AT6, Autologous transfusion devices

© ISO 2016 – All rights reserved

9


ISO 1 5 675 : 2 01 6(E)

ICS  11.040.40

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© ISO 2016 – All rights reserved