INTERNATIONAL ISO

STANDARD 8638

Third edition
2010-07-01

Cardiovascular implants and

extracorporeal systems - Extracorporeal
blood circuit for haemodialysers,
haemodiafilters and haemofilters
Implants cardiovasculaires et systemes extracorporels - Circuit
sanguin extracorporel pour les hemodialyseurs, les hemodiafiltres et les
hemofiltres

Reference number
--~-
--
-- - ISO 8638:2010(E)

~IS01
---~- -
-- --
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©ISO 2010
 ISO 8638:2010(E)

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Published in Switzerland

ii © ISO 2010- All rights reserved

 ISO 8638:2010(E)

Contents Page

Foreword ............................................................................................................................................................iv
Introduction .........................................................................................................................................................v
1 Scope ......................................................................................................................................................1
2 Normative references ............................................................................................................................ 1
3 Terms and definitions ...........................................................................................................................2
4 Requirements ......................................................................................................................................... 2
4.1 Biological safety .................................................................................................................................... 2
4.2 Sterility ....................................................................................................................................................3
4.3 Non-pyrogenicity ...................................................................................................................................3
4.4 Mechanical characteristics ...................................................................................................................3
4.5 Expiry date .............................................................................................................................................5
4.6 Tubing compliance ................................................................................................................................5
5 Test methods .........................................................................................................................................5
5.1 General ...................................................................................................................................................5
5.2 Biological safety .................................................................................................................................... 6
5.3 Sterility ....................................................................................................................................................6
5.4 Non-pyrogenicity ................................................................................................................................... 6
5.5 Mechanical characteristics ................................................................................................................... 6
5.6 Expiry date .............................................................................................................................................9
5.7 Tubing compliance ................................................................................................................................9
6 Labelling ...............................................................................................................................................10
6.1 Labelling on the device ....................................................................................................................... 10
6.2 Labelling on the unit container .......................................................................................................... 10
6.3 Labelling on the outer container ........................................................................................................ 10
6.4 Accompanying documentation .......................................................................................................... 11
Bibliography ......................................................................................................................................................13

©ISO 2010- All rights reserved iii

 ISO 8638:201 O(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of 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 of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 8638 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.

This third edition cancels and replaces the second edition (ISO 8638:2004), which has been technically
revised.

iv ©ISO 2010- All rights reserved

 ISO 8638:2010(E)

Introduction

This International Standard is concerned with the extracorporeal blood circuit manufactured for single use and
intended for use in conjunction with haemodialysers, haemodiafilters and haemofilters. The requirements
specified in this International Standard for the extracorporeal blood circuit will help to ensure safety and
satisfactory function.

It was not found practicable to specify materials of construction. This International Standard therefore requires
only that materials have been tested and that the methods and results are made available upon request.

The dimensions of the connectors intended for connecting the extracorporeal blood circuit to a haemodialyser,
haemodiafilter or haemofilter have been specified to ensure compatibility with these devices, as specified in
ISO 8637. The design and dimensions have been selected in order to minimize the risk of leakage of blood
and ingress of air. Connectors with either fixed or loose locking shells are permitted.

This International Standard reflects the consensus of physicians, manufacturers and other interested parties
for devices that are approved for clinical use. Conformance with this International Standard is voluntary and it
is not intended to supersede any national regulation.

© ISO 2010 -All rights reserved v

 INTERNATIONAL STANDARD ISO 8638:2010(E)

Cardiovascular implants and extracorporeal systems -

Extracorporeal blood circuit for haemodialysers,
haemodiafilters and haemofilters

1 Scope
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer
protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

This International Standard does not apply to:

haemodialysers, haemodiafilters or haemofilters;

plasmafilters;

haemoperfusion devices;

vascular access devices;

blood pumps;

pressure monitors for the extracorporeal blood circuit;

air detection devices;

systems to prepare, maintain or monitor dialysis fluid;

systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or

haemoconcentn::~tion

NOTE Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in
ISO 8637.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.

ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment-
Part 2: Lock fittings

ISO 7864, Sterile hypodermic needles for single use

ISO 10993-1, Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk
management process

ISO 10993-4, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood

© ISO 2010- All rights reserved 1

 ISO 8638:2010(E)

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

3 Terms and definitions

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

3.1
air capture chamber
component intended to capture air and which can provide compliance to the blood circuit or allow pressure to
be monitored

NOTE Air capture chambers are also known as drip chambers, bubble traps or venous and arterial blood chambers.

3.2
extracorporeal blood circuit
blood tubin!=J and inte!=jral accessory tubin~, includin~ fluid and infusion tubing, for attaching the extracorporeal
blood circuit to pressure monitors and integral components

EXAMPLES (Of integral components.) Air-capture chambers and transducer protectors.

3.3
fluid pathway
internal surfaces of the extracorporeal blood circuit

3.4
labelling
written, printed, graphic or electronic matter that:

is affixed to a medical device or any of its containers or wrappers

or

accompanies a medical device and which is related to identification, technical description and use of that
medical device, but excluding shipping documents

3.5
pump segment
portion of the extracorporeal blood circuit (3.2) that is acted upon by the blood pump

3.6
transducer protector
pressure-transmitting sterile barrier
component of the extracorporeal blood circuit (3.2) that is intended to provide an interconnection between the
extracorporeal blood circuit and the haemodialysis machine while allowing the pressure within the
extracorporeal blood circuit to be measured by the machine

4 Requirements

4.1 Biological safety

Parts of the device that are Intended to come into direct or indirect contact with bluuu ~hall be evalualeu rur
freedom from biological hazards, in accordance with 5.2.

2 © ISO 2010- All rights reserved

 ISO 8638:2010(E)

NOTE Attention is drawn to the need to establish whether national regulations or national standards governing
toxicology and biocompatibility testing exist in the country in which the device is produced and, if applicable, in the
countries in which the device is to be marketed.

4.2 Sterility

All fluid contacting surfaces of the device, and the mating surfaces of all connectors integral to the device,
shall be sterile. Compliance shall be verified in accordance with 5.3.

4.3 Non-pyrogenicity

The blood pathway of the device shall be non-pyrogenic. Compliance shall be verified in accordance with 5.4.

4.4 Mechanical characteristics

4.4.1 Structural integrity

The device shall be capable of withstanding a positive pressure of 1,5 x the manufacturer's recommended
maximum pressure and a negative pressure not exceeding 700 mmHg (93,3 kPa below atmospheric
pressure) or the highest obtainable negative pressure if at high elevation, when tested in accordance with
5.5.1.

4.4.2 Connectors to haemodialyser, haemodiafilter or haemofilter

4.4.2.1 Except where the haemodialyser, haemodiafilter or haemofilter and the extracorporeal blood
circuit are designed as an integral system, the dimensions of the connectors for the haemodialyser,
haemodiafilter or haemofilter shall be as given in Figure 1. Compliance shall be verified in accordance
with 5.5.2.

4.4.2.2 Connectors made of semi-rigid materials shall meet the performance requirements of ISO 594-2.

4.4.3 Connectors to vascular access device

Except where the extracorporeal blood circuit and the vascular access device are an integral system, the
dimensions of the connectors intended for connection to vascular access devices shall be a male 6 % (Luer)
taper lock fitting (see ISO 594-2). Connectors made of semi-rigid materials shall meet the performance
requirements of ISO 594-2 taper lock fittings. Compliance shall be verified in accordance with 5.5.3.

4.4.4 Connectors to ancillary components

All parts of the extracorporeal blood circuit intended for use with non-integral ancillary components, such as
heparin lines, pressure-transducer lines, medication-administration lines and level-adjustment lines, shall
terminate in fittings that meet the performance requirements of ISO 594-2 taper lock fittings. Compliance shall
be verified in accordance with 5.5.4.

4.4.5 Colour coding

The arterial patient-connection end shall be colour-coded red, and the venous patient-connection end shall be
colour-coded blue. The coding shall be prominently displayed within 100 mm of the end of the tubing.
Compliance with this requirement shall be verified in accordance with 5.5.5.

© ISO 2010- All rights reserved 3

ISO 8638:2010(E)

Dimensions in millimetres

lf1
r- N
0 oo·
lf1 o·o I
0 +
~
00
sVI m
m ~
"' s
s

2 ±0,1
0

T 12,8 -0,2 4

Figure 1 - Main fitting dimensions of extracorporeal blood circuit connector to blood ports of
haemodialyser, haemodiafilter or haemofilter

4.4.6 Access ports

4.4.6.1 Needle access ports

Needle access ports shall not leak when tested in accordance with 5.5.6.1. The access ports shall be
designed so as to minimize the risk of the needle piercing the tube completely and causing injury.

4.4.6.2 Needleless access ports

Needleless access ports shall not leak when tested in accordance with 5.5.6.2.

4.4.7 Blood pathway volume

The range of the blood pathway volume of the extracorporeal blood circuits shall be specified by the
manufacturer. Compliance with this requirement shall be verified in accordance with 5.5.7.

NOTE The blood pathway volume is also known as the priming volume.

4.4.8 Air-capture chamber fill level

The recommended fill level of the air-capture chamber should be marked on the air-capture chamber if that
level is required for proper operation of some monitoring system. Compliance with this requirement shall be
verified in accordance with 5.5.8.

4 ©ISO 2010- All rights reserved

 ISO 8638:2010(E)

4.4.9 Transducer protectors

4.4.9.1 Integral transducer protectors

Extracorporeal blood circuits supplied with integral transducer protectors shall be capable of preventing
cross-contamination. The transducer protector shall be capable of maintaining a secure and leak-free
connection to the haemodialysis machine when subjected to pressures of 1,5 x the manufacturer's
recommended maximum pressure for the device. The machine side of the transducer protector shall be
transparent (clear) to allow for visual inspection of blood contamination during use. Compliance with this
requirement shall be in accordance with 5.5.9.

4.4.9.2 Non-integral transducer protectors

If not supplied as an integral component of the extracorporeal blood circuit, connectors shall be provided to
allow the use of a transducer protector to prevent cross contamination. The transducer protector shall be
capable of maintaining a secure and leak-free connection to the haemodialysis machine when subjected to
pressures of 1,5 x the manufacturer's recommended maximum pressure for the device. The machine side of
the transducer protector shall be transparent (clear) to allow for visual inspection of blood contamination
during use. Compliance with this requirement shall be in accordance with 5.5.9.

4.4.10 Blood pathway flow dynamics

Extracorporeal blood pathways shall be designed to m1n1m1ze harmful effects to the blood components.
Compliance with this requirement shall be verified in accordance with 5.5.1 0.

4.4.11 Pump segment performance

The performance characteristics of the pump segment shall be evaluated over the range of inlet pressures
(normally 0 mmHg to -250 mmHg).

Compliance with this requirement shall be verified in accordance with 5.5.11.

4.5 Expiry date

If the expiry date is given, it shall be validated. Accelerated stability studies are acceptable if real time data are
not available. Compliance with this requirement shall be verified in accordance with 5.6.

4.6 Tubing compliance

The blood tubing shall be capable of being occlusively clamped by the venous line clamp of the dialysis
delivery system(s) with which the extracorporeal blood circuit is intended to be used, as indicated in the
labelling for the blood tubing. Compliance with this requirement Ght:~ll be verified in accordance with 5.7.

5 Test methods

5.1 General

The performance characteristics specified in Clause 4 shall be determined prior to marketing a new type of
device and shall be re-evaluated after changes in the device that might alter its performance.

The sample of devices shall be drawn at random from the manufacturer's production and shall have passed
all applicable quality control steps, as well as sterilization, if applicable. They shall be prepared according to
the manufacturer's recommendations as though they are to be used for a clinical procedure.

©ISO 2010- All rights reserved 5

ISO 8638:2010(E)

Measurements shall be made in vitro at (37 ± 1) oc.

When the relationship between variables is non-linear,
sufficient determinations shall be made to permit interpolation between the data points. The techniques of
measurement are reference tests. Other test methods may be used, provided it can be shown that they are
validated and of comparable precision and reproducibility.

The test systems shown do not indicate all the necessary details of practicable test apparatus. The design and
construction of actual test systems and their establishment shall also address the many factors contributing to
measurement error, including, but not limited to, pressure measurement errors due to static head effects and
dynamic pressure drops; parameter stabilization time; uncontrolled temperature variations at non-constant
flow rates; pH; degradation of test substances due to heat, light and time; degassing of test fluids; trapped air;
and system contamination by foreign material, algae and bacteria.

5.2 Biological safety

The biological safety of devices that are intended to come into direct or indirect contact with the patient's blood
shall be evaluated on samples of each new type of device prior to its marketing or after any change in the
materials of construction of that type of device or after any change in the method of sterilization. Testing sh811
be carried out in accordance with ISO 10993-1, ISO 10993-4 or ISO 10993-7, as relevant.

5.3 Sterility

Compliance with 4.2 shall be verified by inspection of the device records that show that the device has been
exposed to a validated sterilization process.

5.4 Non-pyrogenicity

Compliance with 4.3 shall be verified in accordance with ISO 10993-11.

5.5 Mechanical characteristics

5.5.1 Structural integrity

5.5.1.1 Positive pressure

Compliance with 4.4.1 (positive pressure) shall be determined by either of the following tests.

a) oc.
Fill the device with water at (37 ± 1) Cap all connections with applicable caps. Subject the device to a
pressure of 1,5 x the manufacturer's recommended maximum pressure. Maintain pressure for a minimum
of 10 min and inspect for visible signs of leakage.

b) Cap all ports with applicable caps. Submerge the device in water at (37 ± 1) oc.
Subject the lumen of the
device to air pressure of 1,5 x the manufacturer's recommended maximum pressure. Maintain pressure
for a minimum of 10 min and inspect the device for leakage of air bubbles.

5.5.1.2 Negative pressure

Compliance with 4.4.1 (negative pressure) shall be determined by either of the following tests.

a) Cap all ports with applicable caps. Submerge the device in a water bath at (37 ± 1) °C. Subject the device
to 1,5 x the manufacturer's recommended maximum negative pressure or 700 mmHg (93,3 kPa below
atmospheric pressure) or the highest obtainable sub-atmospheric pressure if at high elevation. Maintain
pressure for a minimum of 10 min and inspect the device for visual signs of leakage.

b) Fill the device with water at (37 ± 1) oc.

Cap all ports with applicable caps. Subject the lumen of the
device to 1,5 x the manufacturer's recommended maximum negative pressure or 700 mmHg (93,3 kPa
below atmospheric pressure) or the highest obtainable sub-atmospheric pressure if at high elevation.
Maintain pressure for a minimum of 10 min and inspect the device for leakage of air bubbles.

6 © ISO 2010- All rights reserved

 ISO 8638:2010(E)

5.5.2 Connectors to haemodialyser, haemodiafilter or haemofilter

Compliance with 4.4.2 shall be determined by inspection (see Figures 1, 2 and 3).

5.5.3 Connector to vascular access device

Compliance with 4.4.3 shall be determined by inspection (see ISO 594-2).

5.5.4 Connectors to ancillary components

Compliance with 4.4.4 shall be determined by inspection (see ISO 594-2).

5.5.5 Colour coding

Compliance with 4.4.5 shall be determined by inspection.

Dimensions in millimetres
2

8
5,5

~10

Key
1 outer cone
2 inner cone

Figure 2 - Gauge for 6 % taper fitting for length of engagement of the male cone of blood inlet and
outlet ports

5.5.6 Access ports

5.5.6.1 Needle access ports

Compliance with 4.4.6.1 shall be determined by the following procedure.

ac
Fill the portion of the extracorporeal blood circuit that contains the access port with water at (37 ± 1)
and apply a pressure 1,5 x the maximum stated by the manufacturer [see 6.4 f) 1)]. Puncture the access
port with a hypodermic needle, as stated by the manufacturer or, if no details are given, of outside
diameter 0,8 mm (21 gauge) and in accordance with ISO 7864. Insert and withdraw the needle five times
through the access port. Maintain the pressure for 6 h and visually inspect the device for the emergence
of water.

© ISO 2010- All rights reserved 7

ISO 8638:201 O(E)

Using the same circuit, completely fill the device with degassed water at (37 ± 1) oc. Seal all ports except
the port to which pressure is applied. Put the device under sub-atmospheric pressure, 1 ,5 x the
manufacturer's recommended maximum negative pressure, unless that sub-atmospheric pressure
exceeds 700 mmHg or is not specified; in that case, apply a sub-atmospheric pressure of 700 mmHg and
seal the apparatus. Access the port in accordance with the manufacturer's instructions. Access the port
an additional 10 times over a 10 min period. Maintain the pressure for 6 h and visually inspect the device
for the leakage of air into the tubing. The water may be circulated through the device.

6.6.6.2 Nccdlclcss access ports

Compliance with 4.4.6.2 shall be determined by the following procedure.

Fill the portion of the extracorporeal blood circuit that contains the access port with water at (37 ± 1) oc
and apply a pressure 1 ,5 x the maximum stated by the manufacturer [see 6.4 f) 1)]. Access the port in
accordance with the manufacturer's instructions. Access the port an additional 10 times over a 10 min
period. Maintain the pressure for 6 h and visually inspect the device for the emergence of water.

Using the same circuit, completely fill the device with degassed water at (37 ± 1) oc.
Seal all ports except
the port to which pressure is applied. Put the device under sub-atmospheric pressure, 1,5 x the
manufacturer's recommended pressure, unless that sub-atmospheric pressure exceeds 700 mmHg or is
not specified; in that case, apply a sub-atmospheric pressure of 700 mmHg and seal the apparatus.
Access the port in accordance with the manufacturer's instructions. Access the port an additional
10 times over a 10 min period. Maintain the pressure for 6 h and visually inspect the device for the
leakage of air into the tubing. The water may be circulated through the device.

5.5.7 Blood pathway volume

Compliance with the 4.4.7 shall be verified by filling the blood pathway of the device with water and measuring
the volume of the water needed to fill this pathway. The air-capture chambers shall be filled to their normal
operating level.

5.5.8 Air-capture chamber fill level

Compliance with this marking shall be by visual inspection of the existence of a marking giving the normal
operating level.

5.5.9 Transducer protectors

Compliance with 4.4.9.1 and 4.4.9.2 shall be verified by testing to withstand 1,5 x the maximum pressure
specified by the manufacturer according to the following.

With the machine side open, fill the extracorporeal blood circuit side with water, pressurize the extracorporeal
side to 1,5 x the manufacturer's recommended maximum pressure and hold for 1 h; examine for signs of
leakage. Leakage shall not occur at the Luer connector, at the housing welds or through the membrane.

Visually inspect the device component to ensure compliance with the connection requirements of 4.4.4.

Visually inspect the transducer for transparency of the machine side.

5.5.10 Blood pathway flow dynamics

Compliance with 4.4.1 0 shall be verified by review of the manufacturing risk management file for the device.

5.5.11 Pump segment performance

Compliance with 4.4.11 can be determined by evaluating the flow rate changes over time with a negative inlet
pressure between 0 mmHg and -250 mmHg. The testing shall be performed over the range of blood flows

8 © ISO 2010- All rights reserved

 ISO 8638:2010(E)

recommended by the manufacturer with back-pressures. The results shall be used to give the
recommendations in 6.4 f) 3).

Dimensions in millimetres

0 +0,005
¢5,925 -0,005 ¢5 85 0

I
I
i ~

0
(¢6,33) oo·
I

I L/"1
N
a-

-··-
+0,005
¢6,465 0
r I
I
0
¢6,405 -0,005
'
0 0
¢5,827 -0,005 ¢6,502 -0,005
I-
I

0 0
¢6,367 -0,005 ¢5,962 -0,005

Figure 3 -Test device used for ISO blood port connectors

5.6 Expiry date

Compliance with 4.5 can be met by accelerated or real time testing of the device for biological safety, sterility
and mechanical integrity after storage for a period corresponding to the expiry date.

5.7 Tubing compliance

Compliance with 4.6 can be verified by placing the tubing in the dialysis machine clamp for which the product
will be labelled, and activating the clamp. The circuit shall then be pressurized to 1 ,5 x the manufacturer's
recommended maximum pressure and observed for leakage past the clamp for 20 min. No leakage shall
occur.

© ISO 2010- All rights reserved 9

ISO 8638:2010(E)

6 Labelling

6.1 Labelling on the device

The device shall be labelled with at least the following information:

a) red and blue markings at patient connection ends;

b) air-capture chamber level markings, if appropriate.

NOTE In all cases, symbols from ISO 7000 or ISO 15223 can be used where appropriate.

6.2 Labelling on the unit container

At least the followin~ information shall be visible on or through the unit container:

a) the manufacturer's name and address;

b) the proprietary device name:

c) the manufacturer's identifying code for the device;

d) the lot number;

e) a statement of sterility and non-pyrogenicity, and whether the entire contents of the container or the fluid
pathways only are sterile;

f) the expiry date, stated as mm/yyyy or yyyy/mm;

g) a statement of single use;

h) the statement, "Read the instructions beforP. tJsP.";

i) the method of sterilization;

j) if not provided as an integral part of the set, a statement stating, "Caution, a transducer protector must be
installed on each pressure monitoring line prior to patient use";

k) the len~th and internal diameter of the pump segment.

NOTE In all cases, symbols from ISO 7000 or ISO 15223 can be used where appropriate.

6.3 Labelling on the outer container

At least the following information shall appear on the outer container:

a) the manufacturer's name and address;

b) the name and address of the distributor, if different from the information given under a), if applicable and
in accordance with national requirements;

c) the proprietary device name, description of contents and number of devices contained in the outer
container;

d) the manufacturer's identifying code for the device;

e) the lot number;

10 © ISO 2010- All rights reserved

 ISO 8638:2010(E)

f) a statement of sterility and non-pyrogenicity;

g) the expiry date, stated as mm/yyyy or yyyy/mm;

h) instructions and warnings regarding handling and storage.

NOTE In all cases, symbols from ISO 7000 or ISO 15223 can be used where appropriate.

6.4 Accompanying documentation

At least the following information shall be supplied with each outer container:

a) the manufacturer's name and address;

b) the proprietary device name;

c) the manufacturer's identifying code for the device;

d) a statement of sterility and non-pyrogenicity and method of sterilization;

e) a statement of single use;

f) cautions and warnings, including, but not limited to, the following:

1) maximum pressures (both positive and negative) and applicable blood flow limitations, such as the
maximum blood flow rate;

2) a statement that the device is compatible with the relevant components of the equipment for which it
is intended;

3) a statement that the actual blood flow rate might differ from the blood flow rate indicated by the
machine and that the difference might change with time, if applicable;

4) a warning not to kink the tubing;

5) a statement concerning the potential for air infusion and a recommendation to use an air detector;

6) a warning that locking connectors might separate if either the male or female part is exposed to a
lubricant, for example, by transfer of lubricant from a lubricated needleless valve;

7) a warning that the air detector will not detect air introduced by a syringe through an access port distal
to the air detector, if applicable;

g) instructions on how to prepare the extracorporeal blood circuit before use;

h) an explanation of the colour coding that is used to identify the arterial and venous lines;

i) if transducer protectors are an integral part of the device, specifications of the transducer protectors and
instructions for using them and replacing them if wetted by saline or if blood shall be included;

j) details of ancillary equipment required;

k) a general description of the extracorporeal blood circuit;

I) details of the orientation of the connectors to the haemodialyser or haemodiafilter in relation to the
dialysis fluid lines;

m) if monitor lines are included, an instruction that devices to prevent contamination of monitors by blood
shall be used, unless these devices are part of the extracorporeal blood circuit;

©ISO 2010- All rights reserved 11

ISO 8638:2010(E)

n) a list of disinfectants for external application (e.g. when sampling blood) that are compatible with the
components of the extracorporeal blood circuit and a warning that the compatibility of other disinfectants
with the components of the extracorporeal blood circuit shall be determined prior to clinical use;

o) the recommended procedure for terminating the operational procedure, if applicable;

p) typical fluid circuit diagrams;

q) a statement that the generic names of materials that directly or indirectly contact the blood pathway are
available to the user upon request;

r) the machine or machines for which the extracorporeal blood circuit is intended;

s) the largest needle recommended by the manufacturer for accessing the access ports;

t) volume of the blood pathway and blood circuit.

NOTE In all cases, symbols from ISO 7000 or ISO 1fi??~ r.Rn hP. used where appropriate.

12 ©ISO 2010- All rights reserved

 ISO 8638:2010(E)

Bibliography

[1) ISO 7000, Graphical symbols for use on equipment- Index and synopsis

[2] ISO 8637, Cardiovascular implants and artificial organs- Haemodialysers, haemodiafilters,
haemofilters and haemoconcentrators

[3) ISO 11135-1, Sterilization of health care products- Ethylene oxide- Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices

[4) ISO/TS 11135-2, Sterilization of health care products- Ethylene oxide- Part 2: Guidance on the
application of ISO 11135-1

[5) 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

[6] ISO 11137-2, Sterilization of health care products- Radiation- Part 2: Establishing the sterilization
dose

[7) ISO ·1·1·137 -3, Sterilization of health care products- Radiation- Part 3: Guidance on dosimetric
aspects

[8) ISO 14937, Sterilization of health care products- General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for
medical devices

[9) ISO 15223-1, Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied- Part 1: General requirements

[1 0] ISO 15223-2, Medical devices - Symbols to be used with medical device labels, labelling, and
information to be supplied- Part 2: Symbol development, selection and validation

[11] ISO 17665-1, Sterilization of health care products - Moist heat - Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices

[12] ISO 17665-2, Sterilization of health care products- Moist heat- Part 2: Guidance on the application
of ISO 17665-1

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ISO 8638:2010(E)

ICS 11.040.40
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© ISO 2010- All rights reserved