इंटरनेट मानक

Disclosure to Promote the Right To Information

Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.

“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न' 5 तरफ”

Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”

IS 13878 (1993): Extra corporeal circuit for

haemodialysers, haemofilters and haemoconcentrators [MHD 6:
Thoracic and Cardiovascular Surgery Instruments]

“!ान $ एक न' भारत का +नम-ण”

Satyanarayan Gangaram Pitroda
“Invent a New India Using Knowledge”

“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता ह”

है”
ह
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”
 IS 13878 : 1993
IS0 8638 : 1989

( Reaffirmed 2005 )

Indian Standard
EXTRACORPOREAL BLOOD CIRCUIT FOR
HAEMODIALYSERS, HAEMOFILTERS AND
HAEMOCONCENTRATORS - SPECIFICATION

UDC 615’47 : 615’38

@ BIS 1993

BUREAU OF INDIAN STANDARDS

MANAU BHAVAN, 9 BAHADUA SHAH ZAFAR MARG
NEW DELHI 110002

December 1993 Price Group 5

 .

Thoracic and Cardiovascular Surgery Instruments Sectional Committee, MHD 6

NATIONAL FOREWORD

This Indian Standard which is identical with IS0 8638 : 1989 ‘Extracorporeal blood circuit for
haemodialysers, haemofilters and haemoconcentrators ‘ , issued by the International Organization
for Standardization, was adopted by the Bureau of Indian Standards on the recommendation of
the Thoracic and Cardiovascular Surgery Instruments Sectional Committee and approval of the
Medical Equipment and Hospital Planning Division Council.

This Indian Standard covers the requirements for extracorporeal circuit intended for single use
in conjunction with haemodialysers, haemofilters and haemoconcentrators with a view to ensure
safety and satisfactory function of the device.

It has not been found practicable to specify materials of construction nor to give test methods
for biocompatibility, validation of sterility, non-pyrogenicity and certain performance charac-
teristics of the extra-corporeal circuit. This standard, therefore only requires that the material
has been tested and that the methods and the results are made available upon request.
The specification for physical characteristics have been limited to those deemed necessary for
safe and effective function of the device. A design standard is required for connectors to the
blood ports of the haemodialysers, haemofilter and haemoconcentrator and to the blood access
device to ensure the compatibility of the circuit and the corresponding device. These design
and dimensions specifications have been selected to minimise the risk of leakage of blood and
the ingress of air. Connectors with either fixed or loose tacking shells are permitted.
The text of the above menrioned IS0 standard has been approved as suitable for publication as
Indian Standard without deviations. Certain conventions are, however not identical to those
used in Indian Standards. Attention is particularly drawn to the following:
a) Wherever the words ‘International Standard’ appear referring to this standard, they
should be read as ‘Indian Standard’.
b) Comma ( , ) has been used as a decimal marker while in Indian Standards, the current
practice is to use a point ( . ) as the decimal marker.
The Technical Committee responsible for the preparation of this standard has reviewed the
provision of the following international standard appearing in the normative reference of this
standard and has decided that they are acceptable for use in conjunction with this standard.

IS0 472 : 1979 Plastics - Vocabulary ( revised in 1988 ).

IS0 594-2 Conical fittings with a 6 percent ( Luer ) taper for syringes, needles and certain other
medical equipment - Part 2 : Lock fittings ( published in 1992 ).

IS0 8637 : 1989 Haemodialysers, haemofilters and haemoconcentrators-

For the purpose of deciding whether a particular requirement of this standard is complied with,
the final value, observed or calculated, expressing the result of a test, shall be rounded off in
accordance with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)‘. The number
of significant places retained in the rounded off value should be the same as that of the
specified value in this standard.
 IS 1387’8: 1993
IS0 8838: 1989

Indian Standard
EXTRACORPOREAL BLOOD CIRCUIT FOR
HAEMODIALYSERS, HAEMOFILTERS AND
HAEMOCONCENTRATORS - SPECIFICATION

1 Scope 3 Definitions

This International Standard specifies requirements for the For the purposes of this International Standard the following
extracorporeal blood circuit for single use which is to be used in definitions apply.
conjunction with haemodialysers, haemofilters and haemo-
concentrators. 3.1 arterial blood circuit: Portion of the extracorporeal
blood pathway from the vascular access device of the patient to
Materials of construction and test methods for biocompatiL the blood inlet of the haemodialyser, haemofilter or haemo-
bit&y, validation of sterility, non-pyrogenicity and some per- concentrator.
formance characteristics are not specified; the rationale for
these omissions is given in the Introduction. 3.2 non-pyrogenic : Free of pyrogenic materials within the
limit of error of test methods for such determinations, as de-
fined by the national regulatory agency of the country in which
This International Standard applies to the blood tubing and in-
the device is to be marketed or, where available, an Inter-
tegral accessory tubing, including fluid and infusion tubings
national Standard, and maintained in that state by suitable
and tubing for attaching the extracorporeal blood circuit to
protection.
pressure monitors.

This International Standard does not apply to haemodialysers, 3.3 pump segment: Portion of the extracorporeal blood
haemofilters, haemoconcentrators, vascular access devices: circuit that is acted upon by the blood pump.
blood pumps, pressure monitors of the extracorporeal blood
circuit, air detection devices, haemodialysis systems to 3.4 sterile : Free from all living organisms within the limits of
prepare, maintain and monitor the dialysing fluid, and hardware validation tests for sterility and maintained in that state by
used to perform haemofiltration or haemoconcentration. suitable protection.

NOTE ~ Requirements for haemodialysers. haemofikers and haemo- 3.5 venous blood circuit: Extracorporeal blood circuit from
concentrators are specified in IS0 8637. the outlet of the haemodialyser, haemofilter or haemo-
concentrator, returning blood to the vascular access device of
the patient.

2 Normative references 4 Requirements

The following standards contain provisions which, through
4.1 Good manufacturing practice
reference in this text, constitute provisions of this International
Standard. At the time of publication, the editions indicated The extracorporeal circuit shall be manufactured in a clean
were valid. All standards are subject to revision, and parties to environment and the fluid pathways shall be free of visible
agreements based on this International Standard are encouraged foreign material.
to investigate the possibility of applying the most recent
editions of the standards indicated below. Members of IEC NOTE ~ Attention is drawn to the need to establish whether codes for
good manufacturing practice exist in the country in which the device is
and IS0 maintain registers of currently valid International
produced and, it applicable, in the countnes in which the device is to
Standards.
be marketed.

IS0 472: 1979, Plastics - Vocabulary Testing shall be carried out in accordance with 5.1.

IS0 5942 lb, ConIcal iittings with a 6 % fLuerl taper for 4.2 Toxicology and biological compatibility
syringes, needles and certain other medical equipment -
Part 2 : 1 ock fittings. Samples of the device shall be tested for freedom from toxicity
using, if available, the method specified in the relevant national
ISO 6637 : 1989, Haemodlalysers, haemofilters and haemo- standard and the results of such tests shall indicate freedom
concentrators. from biological hazard. If requested, details of the test method

11 To be published
 IS 13878: 1993
ISo 8838: 1989

and the results shall be made available by the manufacturer of 4.6.2 Connectors to haemodialyser, haemofilter or
the device. haemoconcentrator

NOTE - Attention is drawn to the need to establish whether national The dimensions of the fitting for connection to the haemo-
regulations or national standards governing toxicology and biocom- dialyser, haemofilter or haemoconcentrator shall be as gtven irl
patibility testing exist in the country in which the device is produced
figures 1 to 3.
and, if applicable, in the countries in which the device is to be
marketed.
The dimensions shall be checked in accordance with 5 6.2
Testing shall be carried out in accordance with 5.2.
4.6.3 Connector to vascular access device
4.3 Sterility
The fitting for connecting the extracorporeal clrcllit to a
The fluid pathways of the device shall be supplied sterile. vascular access device shall be a male 6 % (Luer) taper lock fit-
ting; this fitting shall be in accordance with IS0 5942.
NOTE - Attention is drawn to the, need to establish whether national
regulations or national standards governing sterility testing exist in the
The fitting shall be checked in accordance with 5.6.3.
country in which the device is produced and, if applicable, in the
countries in which the device is to be marketed.

Testing shall be carried out in accordance with 5.3. 4.6.4 Connectors to ancillary components

4.4 Pyrogenicity All parts of the extracorporeal circuit intended for use with an-
cillary components, such as heparin lines and pressure
The blood pathway(s) of the device shall be non-pyrogenic. If transducer lines, shall terminate in a female 6 % (Luer) taper
requested, details of the test method(s) and the results shall be lock fitting; this fitting shall be in accordance with IS0 594-2
made available by the manufacturer of the device.
The fittings shall be checked in accordance wtth 5.6.4.
NOTE - Attention is drawn to the need to establish whether national
regulations or national standards governing pyrogen testing exist in the
country in which the device is produced and, if applicable, in the coun- 4.6.5 Access ports
tries in which the device is to be marketed.
Where injection ports are incorporated into the extracorporeal
Testing shall be carried out in accordance with 5.4. circuit, they shall be capable of withstanding, without leakage,
puncture by needle having at least an internal diameter of
4.5 Residues from sterilization 0,8 mm (21 gauge). The injection ports shall be designed so as to
minimize the risk of the needle piercing the lube completely and
After sterilization by the procedure recommended by the causing injury.
manufacturer, the device shall be tested for freedom from toxic
residues that have adverse chemical, physical or biological ef- Testing shall be carried out in accordance with 5.6.5.
fects on the blood or that result in release of clinically signifi-
cant amounts of potentially toxic substances into the blood. If
4.6.6 Colour coding
requested, details of the test methods and the results shall be
made available by the manufacturer of the device. If the arterial extracorporeal blood circuit differs from the
venous extracorporeal blood circuit, the artenal clrcult shall hr
NOTE - Attention is drawn to the need to establish whether national
colour-coded red and the venous circuit shall be colour-coded
regulations or national standards governing testing for residues from
sterilization exist in the country in which the device is produced and, if
blue. The coding shall be prominently displayed within 100 mm
applicable, in the countries in which the device is to be marketed. of the end of the tubing.

Testing shall be carried out in accordance with 5.5. The colour coding shall be checked in accordance with 5.6.6

4.6 Mechanical characteristics 4.7 Physical characteristics

4.6.1 Structural integrity

4.7.1 Volume
Samples of the extracorporeal circuit shall be capable of
withstanding

a) a pressure above atmospheric pressure at sea level thar

is 1,5 times the manufacturer’s specified maximum
pressure, and Testmg shall he tn accordancn wlfh 5. I. 1

b) a pressure 200 mmHg below atmosphenc pressure

(at sea level).

The pump segment shall be capable of withstanding a

minimum of 24 h of use under worst-case conditions.

Testing shall be carried out In accordance with 5.6 1

2
 .

IS 13878 : 1993
ISO8638: 1989 n

Dimensions in milhmetres

L-l4min.

Figure 1 - Main fitting dimensions of extracorporeal circuit connector to blood ports of haemodialwer.
haemofilter or haemoconcentrator

Dimensions in millimetres

Inner cone
/--

-fz- 0,06: 1

Figure 2 - Length of engagement of male and female cones of blood inlet and outlet connectors

3
IS 13878: 1993
IS0 8838: 1989
Dimensions in millimetres

S5,85+goos
@5,925& odG

6
do
+a0

1
@6,465+~oo5

. @6,405-;,oos -

I_ @5,82-f-8,00~,

c
oc
0
I
zs
:.

Figure 3 - Details of 6 % taper test fitting for connector to haemodialyser, haemofilter

or haemoconcentrator blood port

4
 IS 13878: 1993
IS0 8838: 1989

5 Test methods 5.6.1.2.2 Distilled water, freshly boiled, for the subatmos-
pheric test.
5.1 Good manufacturing practice
5.6.1.3 Apparatus
Compliance with the requirement specified in 4.1 shall be deter-
mined by inspection.
5.6.1.3.1 Blood pump, as recommended by the manufac-
turer, or, if the manufacturer does not recommend a blood
5.2 Toxicology and biological compatibility
pump, an adjustable double roller blood pump as com-
The toxicology and biological compatibility of materials (of a monly used for clinical haemodialysis, haemofiltraton or
device) which will come into contact with biological fluids shall haemoconcentration. The rollers shall be just occlusive at the
be determined on samples of each new type of device prior to its test pressure. Each roller shall be occlusive at the beginning,
marketing or after any change in the materials of construction of the middle and the end of the stroke.
that type of device or after any change in the method of steriliza-
tion. 5.6.1.3.2 Stainless steel or plastic vessel for the perfusate.

NOTE - Testing should be carried out using the method(s) specified in

appropriate natiorlal regulations or national standards. 5.6.1.3.3 Heating device, capable of maintaining the per-
fusate at 37 OC & 1 OC.

5.3 Sterility
5.6.1.3.4 Jig, for puncturing the access port at the same
The sterilization process shall be validated on samples of the location.
finished device prior to marketing a new type of device, and,
thereafter, the sterilization process shall be monitored for each
5.6.1.3.6 Needle, having the largest internal diameter recom-
. batch.
mended by the manufacturer or having an internal diameter of
0,s mm 121 gauge), whichever is the larger.
5.4 Pyrogenicity

Testing for pyrogens shall be carried out on samples of each 6.6.1.3.6 Open or occluded steel reference connectors,
new type of device prior to-marketing, and, theretifter, the as appropriate (the connectors for the blood access and an-
manufacturer shall perform pyrogen testing at intervals shown cillary tubing), which comply with the requirements specified in
to ensure non-pyrogenicity of the device.
IS0 594-2. See figure 3.

5.5 Residues from sterilization 5.6.1.3.7 Blood port, complying with the requirements
specified in clause 4.6.3 of IS0 8637 : 1989.
Samples of the finished device shall be tested for potentially
toxic residues by recognized toxicological methods prior to 5.6.1.3.8 Tubing, to be attached to the blood port (unless it
marketing a new type of device, and, thereafter, the manufac- is occluded), and to the connectors to the blood access con-
turer shall test for toxic residues at intervals shown to ensure nector and to the ancillary tubing connector (5.6.1.3.61 that can
the safety of the device and after any change of materials of withstand the test conditions.
construction.

6.6.1.3.9 Pressurized air source, capable of maintaining the

5.6 Mechanical characteristics extracorporeal circuit at the specified pressure above at-
mospheric pressure.
5.6.1 Structural integrity and access port leakage

5.6.1.3.10 Suction device, capable of maintaining the

The test described shall be carried out prior to marketing a new
specified pressure below atmospheric pressure.
type of device; it is not intended to be a quality control test.

5.6.1.1 Principle 5.6.1.3.11 Pressure gauges, accurate to + 10 mmHg.

Subjection of the extracorporeal circuit to simulated use during 5.6.1.3.12 Vessel, filled with water, that will accommodate
which the access port is punctured. Subjection of the extracor- the extracorporeal circuit during the subatmospheric pressure
poreal circuit to the specified pressures (see 4.6.1) above and test.
below atmospheric pressure at sea level. Observation for leaks.

5.6.1.4 Sampling and preparation of test samples

5.6.1.2 Reagents

A statistically signiiicant sample of extracorporeal circuits

5.6.1.2.1 Anticoagulated bovine or human plasma, with a drawn at random from the manufacturer’s production which
Xotein mass concentration of 60 g/l t_ 5 g/l for the perfusate have passed all safety and quality control measures, where ap-
luring simulated use. plicable, shall be used.

5
IS 13878: 1993
IS0 8638 : 1989

5.5.1.5 Procedure 5.6.1.5.4 At the conclusion of the test, check that the pump
segment is undamaged.

5.6.1.5.1 Perform *simulated dialysis by recirculating the

plasma (5.6.1.2.1) at 37 OC f 1 OC through the extracorporeal 5.6.1.6 Expression of results
circuit at the manufacturer’s recommended maximum pressure
and flow rate.
5.6.1.6.1 Test above atmospheric pressure (1,5 times maxi-
After 15 min of perfusion, puncture the access ports, if any, six mum pressure)
times in the same location with the needle (5.6.1.3.5).
An unsatisfactory test is shown if a steady stream of bubbles is
Continue the perfusion for a total of 24 h. seen after 30 s. See 5.6.1.5.2.

The results shall be recorded as “Pass” or “Fail”.

5.6.1.6.2 Attach the connections of the extracorporeal circuit
to appropriate fittings as shown in figure 4 and pressurize the
extracorporeal circuit to a pressure 1,5 times the maximum 5.6.1.6.2 Test at subatmospheric pressure
operating pressure recommended by the manufacturer. Im-
merse the extracorporeal circuit in water at 37 OC f 1 OC for An unsatisfactory test is shown by the appearance of bubbles
1 min, while maintaining the pressure inside the extracorporeal in the fluid pathway of the blood tubing.
circuit constant.
The results shall be recorded as “Pass” or “Fail”.
After 30 s examine the circuit and the union of the connectors
for the blood port, vascular access device and ancillary com-
ponents for leakage of air indicated by a steady stream of 5.6.1.6.3 If the pump segment was damaged, (see 5.6.1.5.4).
bubbles. the result shall be recorded as “Fail”.

5.6.1.5.3 Fill that part of the circuit and iJs connectors that 5.6.1.7 Test report
may be exposed to a subatmospheric pressure with distilled
water (5.6.1.2.2) and subject it to a pressure 200 mmlig below The test shall be recorded as satisfactory if all samples pass and
atmospheric pressure at sea level. unsatisfactory if any sample fails.

Examine the circuit for leakage af air as indicated by a steady The size of the sample and the rationale for its statistical
stream of bubbles. significance shall be given.

Male ancillary tubing

connector (5.6.1.3.6)
/-

Pressuregauge

L Female ancillary tubing connector lsee 4.6.4)

Connector to
haemodialysar, Female connector 15.6-l .3.6)
to blood access device --

Blood port connector (5.6.1.3.7) Male connector 15.6.1.3.61

i To source of
of haemodialyser, haemofiltsr or to blood access device pressurized gas
haemoconcentrafor

NOTE - Dotted lines represent tubing other fhan the extracorporeal blr,,:d circutt tubing used

“X” across the tubing indicates that it IS clamped (an occluded connector to the extracorporeal blood connector may also be used)

The break between two ends of the extracorporeal blood circuit re~rese~~~sother elements, such as a blood purn[, segment or a drip chamber

Figure 4 - Diagram for testing structural integrity of extracorporeal circuit

6
 IS 13878: 1993
ISO 8&8 : 1989

5.6.2 Connectors to haemodialyser. haemofiiter or 5.7.1.4 Sampling

haemoconcentrator
A statistically significant sample .of extracorporeal circuits
Compliance with the requirement specified in 4.6.2 shall be drawn at random from the manufacturer’s production which
determined by inspection. have passed all safety and quality control measures, where ap-
plicable, shall be used.

6.63 Connector to vascular access device

5.7.1.5 Procedure
. Compliance with the requirement specified in 4.6.3 shall be
Occlude ancillary tubings and fill the blood pathway with water.
determined by inspection.
Drain the fluid as completely as pdssible into the graduated
cylinder. Record the volume collected in the cylinder.
5.6.4 Connectors to ancillary components
6.7.P.6 Expression of results
Compliance with the requirement specified in 4.6.4 shalt be
determined by inspection. Calculate the volume collected, expressed in millilitres, as a
percent= of the manufacturer’s stated volume.

6.6.5 Access ports

5.7.1.7 Test report
The integrity of the access port after it has been punctured by
the needle (see 5.6.1.5.1) shall be tested in accordance with the The test shall be reported as satisfactory if the result for each
method specified in 5.6.1. sample does not differ by more than 20 % from the manufac-
turer’s stated volume.
Compliance with the requirements on disinfection and protec-
tion of the operator from being pricked by the needle shall be 6.7.2 Pump segment
determined by inspection.
Compliance with the requirement specified in 4.7.2 shall be
determined for each batch by inspecting a significant sampla of
5.6.6 Colour coding pump segments from finished extracorporeal circuits that have
passed all safety and quality control measures.
Compliance with the requirement specified in 4.6.6 shall be
determined by inspection.
6 Packaging, marking and accompanying
5.7 Physical characteristics documentation

6.1 Packaging and marking

57.1 Volume

The test described is a referee test. Other tests may be used 6.1.1 Unit containers
provided that the results are within 15 % of the referee test.
Th’is test shall be carried out prior to marketing a new type of At least the following information shall be visible on or through
device; it is not intended to be a quality control test. the unit container :

a) the manufacturer’s name and address;

6.7.1.1 Principle
b) the product name;

Volumetric measurement of the volume of water filling the c) the manufacturer’s identifying code for the device;
blood pathway of the extracorporeal circuit.
d) the lot number which will allow the manufacturing
history of the device to be traced;
5.7.1.2 Reagent
e) a statement of sterility and non-pyrogenicity, and
Tap water. whether the entire contents of the container or the fluid
pathways only are sterile;

5.7.1.3 Apparatus f) the month and year of sterilization, accurate to within

30 days of the actual date of sterilization;

5.7.1.3.1 Graduated cylinder, capable of measuring the g) a statement of single use;

volume of the blood pathway to within +2 b/u.
NOTE .- Symbol 1051 from IS0 7000 : 1989, i.e. @, may also be
used,
5.7.1.3.2 Clamps or occluded connectors to close off the
ancillary tubings. h) the statement “Read the instructions before use”:
IS 13878: 1993
IS0 8838 : 1989

i) a prominent instruction to prepare the extracorporeal noted that the blood gas exchanger inlet line is to be
circuit for use as directed; colour-coded blue and the blood gas exchanger outlet
line is to be colour-coded red;
j) instructions and warnings regarding storage and
handling. g) instructions on how to prepare the extracorporeal
circuit before use;

6.1.2 Outer containers

hl an explanation of the colour coding that is used to iden- *
tify the arterial and venous lines;
At least the following information shall appear on the outer
container :
i) instructions to read the reference documents before
use, if they contain additional information.
a) the manufacturer’s name and address;

b) the name and address of the distributor, if different 6.2.2 Reference documents
from the information given under a);
At least the following information shall be provided to the user
c) the product name, description of contents and number if it does not appear in the accompanying documents (see
of devices contained in the outer container; 6.2.1) :

d) the manufacturer’s identifying code for the device; a) details of ancillary equipment required;

e) the lot number which will allow the manufacturing b) the total volume, in millilitres, of the blood pathway,
history of the device to be traced; assuming that the bubble traps are full;

f) a statement of sterility and non-pyrogenicity; c) the length and internal diameter of the blood pump seg
ment;
g) the month and year of sterilization, accurate to within
30 days of the actual date of sterilization; d) a general description of the extracorporeal circuit;

h) instructions and warnings regarding handling and et details of the orientation of the connectors to the
storage. haemodialyser in relation to the dialysing fluid lines;

f) if monitor lines are included, an instruction that devices

6.2 Documentation
to prevent contamination of monitors by blood should be
used unless these devices are part of the extracorporeal
6.2.1 Accompanying documents circuit;

At least the following information shall be supplied with each g) a list of disinfectants for external application (e.g. when
outer container : blood sampling) that are compatible with the components
of the extracorporeal circuit and a warning that the com-
a) the manufacturer’s name and address; pattbtllty of other disinfectants with the components of the
extracorporeal circuit should be determined prior to clinical
b) the product name;
use;

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

h) the pressure at the inflow of the venous drip chamber
when the venous extracorporeal circuit is perfused at
d) a statement of sterility and non-pyrogenicity and
400 ml/min and 37 T +_ 1 OC with a 32 % ( V/ I’) solution
method of sterilization;
of glycerol and water respectively and with a pressure of
50 mmHg at the outflow of the venous extracorporeal cir-
e) a statement of single use;
cuit;
NOTE - Symbol 1051 from IS0 7000 : 1989, i.e. @ , may also be
used. it the direction of blood flow, if applicable;

f) cautions and warnings, including, but not limited to, the j) the positionmg of tubing connectors;
following :
C:) the recommended procedure for terminating the operas
1) pressure and blood flow rate limitations, tional procedure, if applicable;

2) a statement that the user ensures that the extracor- I) typical fluid circuit diagrams;
poreal circuit is compatible with the device with which it
is used, such as the air detector, the venous clamp, the m) a statement that the following information is available
blood pump and the pressure monitors, with particular to the user on request :
emphasis on compatibility of the air detector,
1) details of the test methods used to obtain the values
3) a statement that if the extracorporeal circuit is at- used in disclosure of the physical charactenstlcs III v/fro
tached to a blood gas exchanger circuit, it should be and to establish biocompatlbtllty (tf applicable),

8
 IS 13878: 1993

IS0 8638: 1989

2) the generic names of materials of construction, in 4) the results of spallation tests and the details of the
accordance with IS0 472 (if applicable : see 5.2, 5.7.1 test method(s) used,
and 5.7.21,
5) the number and size range of particles released by
3) the number and size range of particulate matter and needle puncture of the access port(s) and details of the
fibres in the effluent from the extracorporeal circuit test methods used to make this measurement (see
when prepared as recommended by the manufacturer 5.6.5).
for clinical use, and details of the test method used to
make this measurement.

9 Reprography Unit, BIS, New Delhi, India

Standard Mark
The use of the Standard Mark is governed by the provisions of the Bureau of Indian
Standards Act, I986 and the Rules and Regulations made thereunder. The Standard Mark
on products covered by an Indian Standard conveys the assurance that they have been
produced to comply with the requirements of that standard under a well defined system
of inspection, testing and quality control which is devised and supervised by BIS and
operated by the producer. Standard marked products are also continuously checked by
BIS for conformity to that standard as a further safeguard. Details of conditions under
which a licence for the use of the Standard Mark may be granted to manufacturers or
produceres may be obtained from the Bureau of Indian Standards.
Bureau of Indian Standards
BIS is a statutory institution established under the Bureau of Indian Standards Act, I986 to
promote harmoious development of the activities of standardization, marking and quality
certification of goods and attending to connected matters in the country.

Copyright
BlS has the copyright of all its publications. No part of these publications may be reproduced
in any form without the prior permission in writing of BIS. This does not preclude the free use,
in the course of implementing the standard, of necessary details, such as symbols and sizes, type
or grade designations. Enquiries relating to copyright be addressed to the Director
( Publications ), BLS.

Revision of Indian Standards

Amendments are issued to standards as the need arises on the basis of comments. Standards
are also reviewed periodically; a standard along with amendments is reaffirmed when such review
indicates that no changes are needed; if the review indicates that changes are needed, it is taken
up for revision. Users of Indian Standards should ascertain that they are in possession of the
latest amendments or edition by referring to the latest issue of ‘BIS Handbook’ and ‘Standards
Monthly Addition’. Comments on this Indian Standard may be sent to BIS giving the following
reference:

Dot : No. MHD 6 ( 2561 )

Amendments Issued Since Publication

Amend No. Date of Issue Text Affected

BUREAIJ OF INDIAN STANDARDS

Headquarters:
Manak Bhavan, 9 Bahadur Shah Zafar Marg, New Delhi 110002
Telephones : 331 01 31, 331 13 75 Telegrams : Manaksanstha
( Common to all Offices )

Regional Oflices : Telephone

Central : Manak Bhavan, 9 Bahadur Shah Zafar Marg 331 01 31
NEW DELHI 110002 C 331 13 75
Eastern : l/l4 C. I. T. Scheme VIII M, V. I. P. Road, Maniktola 37 84 99, 37 85 61
CALCUTTA 700054 37 86 26, 37 56 62
(53 38 43, 53 16 40
Northern : SC0 445-446, Sector 35-C, CHANDIGARH 160036
$3 23 84
f235 02 16, 235 04 42
Southern : C. I. T. Campus, IV Cross Road, MADRAS 600113 <
1235 15 19, 235 23 15
Western : Manakalnya, E9 MIDC, Marol, Andheri ( East ) l-632 92 95, 632 78 58
BOMBAY 400093 1632 78 91, 632 78 92
Branch : AHMADABAD. BANGALORE. BHOPAL. BHIJBANESHWAR. COIMBATORE
FARIDARAD. GHAZIABAD, GUWAHATI. HYDERABAD. JAIPUR. KANPUR
LUCKNOW. PATNA. THIRUVANANTIIPURAM.

l’rinted at Printwell Printers, Aligarh, India