ICS 11.040.

20
C 31

GB
NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA
GB 18671-xxxx
Replaces GB 18671—2002

Intravenous infusion needles for single use

(Draft Submitted for Approval)

(This draft completed on 25-04-2008)

Announced XX-XX-XXXX Effective XX-XX-XXXX

General Administration of Quality Supervision, Inspection and Quarantine

of the People's Republic of China
Announced by:
Standardisation Administration of China
 GB 18671—xxxx

Foreword
The present standard replaces GB 18671-2002 “Intravenous infusion needles for single use.” The
present standard differs from GB 18671-2002 primarily with respect to the following:
—the applicable scope was expanded to apply to infusion needles for: gravity feed-type infusion
sets, infusion sets used with pressure infusion equipment, and transfusion sets; and the corresponding
requirements were added;
—added infusion needle with 0.36 mm needle tube specification and corresponding requirements;
—changed product mark to specification mark;
—made connection base requirements mandatory;
—recategorised the requirement relating to inner diameter for quick evaluation of needle tube
openness to flow; it is now a requirement in informational appendix form for further evaluation of needle
tube and needle tip quality; eliminated the qualitative needle tip puncture force test methods;
—changed the pH test so that it makes use of the titrimetric method;
—eliminated the ethylene oxide residue quantity requirement for infusion needles sterilised with
ethylene oxide; added a requirement that packaging make use of dialytic materials;
—revised mark and packaging requirements;
—eliminated the factory pre-shipment inspection.
Appendices A and B of the present standard are regulatory appendices. Appendices C and D are
informational appendices.
The present standard was put forward by the State Food and Drug Administration.
The present standard is under the jurisdiction of the National Technical Committee on
Standardisation of Medical Infusion Devices.
The entities involved in drafting the present standard: Zhejiang Kangdelai Medical Apparatus Stock
Co., Ltd. and the Jinan Quality Supervision and Inspection Centre for Medical Devices of the State Food
and Drug Administration.
The main authors of the present standard: Zhang Honghui, Song Jinzi, Wu Ping, and Gu Yufei.
I
GB 18671—xxxx

Preface
There are two main forms in which intravenous infusion needles are supplied. In one, they are
supplied to hospitals together with infusion and transfusion sets. In the other, they are supplied to hospitals
as independent commercial products. The first form of supply accounts for the great majority of such
needles in China. The sterility, packaging, and labelling requirements of the present standard do not apply
to intravenous infusion needles supplied together with infusion and transfusion sets.
To meet different clinical needs, the present standard does not limit combinations of needle tube
outer diameter and length. However, in view of the need to provide identification for product sales and
clinical use, the present standard requires labelling of needle tube length, tube wall type, and needle tip
type in addition to labelling of needle tube outer diameter.
As a transitional measure, GB 18671-2002 classified the G/T 1962 requirement on inner conical
fittings as a suggested requirement. Seeing as many enterprises have gradually adopted semi-rigid 6% inner
conical fittings, this version has reclassified the requirement as mandatory.

II
 GB 18671—xxxx

Intravenous infusion needles for single use

1 Scope

The present standard establishes requirements for single-use intravenous infusion needles
(hereinafter abbreviated “infusion needles”) having a nominal outer diameter from 0.36 mm to 1.2 mm to
ensure adaptability to gravity feed-type infusion sets, infusion sets used with pressure infusion equipment,
and transfusion sets.
The present standard provides a guide to the properties and quality norms for the materials used in
infusion needles.
Chapter 3 to 8.1 and 8.3 of Chapter 8 of the present standard present quality norms for infusion
needles supplied with infusion and transfusion sets.

2 Cited regulatory documents

The clauses in the documents below become clauses of the present standard by virtue of being
cited by the present standard. If a date is indicated for a cited document, no subsequent revision sheet
(not including corrigenda) or amended version shall apply to the present standard. Nevertheless, the
parties to agreements based on the present standard are encouraged to study whether the most recent
versions of these documents can be used. If no date is indicated for a cited document, then the most
recent version applies to the present standard.
GB/T 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical
equipment—Part 1: General requirements (GB/T 1962.1—2001, idt ISO 594-1: 1986)
GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical
equipment—Part 2: Lock fittings (GB/T 1962.2—2001, idt ISO 594-2: 1998)
GB/T 6682 Water for analytical laboratory use—Specifications and test methods (GB/T 6682—1992,
idt ISO 3696: 1987)
GB 8368—2005 Infusion sets for single use—Gravity feed (ISO 8536-4: 2004 MOD)
GB/T 14233.1 Infusion, transfusion, and injection equipment for medical use—Part 1: Chemical
analysis methods
GB/T 14233.2 Infusion, transfusion, and injection equipment for medical use—Part 2: Biological
testing methods
GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing (GB/T
16886.1-2001, ISO 10993-1: 1997, IDT)
GB 18457 Stainless steel needle tubing for manufacture of medical devices (GB 18457-2001, ISO
9626-1991, eqv)
YY 0286.4 Special infusion sets—Part 4: Single-use infusion sets for use with pressure infusion
equipment (YY 0286.4-2006, ISO 8536-8: 2004 IDT)
YY/T 0296 Hypodermic needles for single use—Colour coding for identification (YY/T 0296-1997, ISO
6009: 1992, IDT)

3 Structure and nomenclature

Fig. 1 shows the structure, names of parts, and needle tube length (L) of a typical infusion needle:

4 Examples of labelling

4.1 Infusion needle specification mark is presented in terms of needle tube nominal diameter, nominal
length, tube wall type, and angle ( ) of first bevel of needle tip. The outer diameter and length are
expressed in “mm”. The tube wall type is represented as RW (regular wall), TW (thin wall), or ETW (extra thin
wall). The angle of the first angular plane of the needle tip is represented as LB (long bevel angle) or SB
(short bevel angle).
4.2 For an infusion needle that is compliant with the present standard, that has a needle tube nominal
outer diameter of 0.7 mm, a nominal length (L) of 30 mm, and a tube wall type of thin wall, and that has a
needle tip first bevel angle that is a long bevel angle, the specification mark is:
0.7 X 30 TW LB
Note 1: The needle tube wall thickness and the needle tip first bevel angle can be selected according to
need. See also D.1.
Note 2: The present standard recommends use of thin-wall or extra-thin-wall needle tubes.

1
GB 18671—xxxx

5 Materials

The needle tubing used to manufacture infusion needles shall comply with the requirements of GB
18457.
Infusion needle components (including lubricants) that come into contact with pharmaceutical
liquids shall also comply with the requirements of Chapters 7 and 8.

Unit is mm

1-sheath;
2-needle tube;
3-needle handle;
4-flexible tube;
5-connecting base;
6-sheathb);
7-needle tube outer diameter specificationc);
a) The flexible tube length is suggested.
b) The sheath is unnecessary when supplied assembled with another product.
c) See GB 18457.
Note 1: The connecting base may have a protective device.
Note 2: Fig. 1 shows the typical structure of an infusion needle. Another structure may be adopted so long as
the same results are achieved.

Fig. 1 Example of typical infusion needle

6 Physical requirements

6.1 Colour labelling

The colour of the needle handle and/or sheath of an infusion needle shall be used to label the
nominal outer diameter of the needle tube. The colour shall comply with the requirements of YY/T 0296.
6.2 Particulate contamination
When tested in accordance with Appendix A.1, the infusion needle contamination index shall not
exceed 90.
6.3 Firmness of connections
6.3.1 When subject to 20 N axial static pulling force for 10 continuous seconds, the connection
between the infusion needle handle and the needle tube shall not break or become loose.

2
 GB 18671—xxxx

6.3.2 The connections between the infusion needle flexible tube and the needle handle and between
the flexible tube and the connecting base shall be able to bear an axial static pulling force of 15 N or 50%
elongation (select that which is attained first) for 10 continuous seconds. Neither connection may
separate or become loose.
6.4 Leaks
The inner cavity of the infusion needle shall have a good seal. It shall not leak when tested in
accordance with A.2.
Infusion needles used together with infusions sets used with pressure infusion equipment shall
comply with the requirements in 6.3 of YY0286.4.
6.5 Flow
When tested in accordance with Appendix A.3, the outflow of water under 20 kPa pressure shall
be no lower than what is specified in Table 1.
Note: You may use the needle inner diameters presented in D.1 for a quick evaluation of the openness to flow
of the needle tube.
Table 1 Infusion needle flow norms
Specification 0.36 0.4 0.45 0.5 0.55 0.6 0.7 0.8 0.9 1.1 1.2
Flow mL/min 2.0 2.5 2.8 3.2 3.8 5.0 11.0 21.0 36.0 48.0

6.6 Length of needle tube

When the nominal length of the needle tube is less than or equal to 15 mm, the needle tube
length (L in Fig. 1) shall be the nominal value ± 1.0 mm. When the nominal length is greater than 15 mm,
the needle tube length shall be the nominal value +1.5 mm/-2.0 mm.
6.7 Needle tip
The infusion needle tip shall be sharp. When examined with normal or corrected vision under 2.5X
magnification, the needle tip shall be free of defects such as burrs and hooks.
Note 1: The first bevel angle of the needle tip is generally 17 ±2° and is known as the “short bevel angle,” but it
can also be 12 ±2°, which is known as the “long bevel angle.” D.2 consists of labelled drawings of needle tip geometric
shapes. It is not necessary to use all the labelled points in the drawings when describing the needle structure.
Note 2: Appendix D.3 presents a method of evaluating needle tip puncture performance.
6.8 Lubricant
If a needle tube is coated with a lubricant, examine the needle with normal or corrected vision.
There shall be no visible lubricant accumulations on the outer surface of the needle tube.
Note 1: An appropriate lubricant would be polydimethylsiloxane.
Note 2: The amount of lubricant applied per square centimetre needle tube surface should not exceed 0.25
mg.
6.9 Connecting base
The conical fitting of the connecting base shall comply with the requirements of GB/T 1962.1 or
GB/T 1962.2.
The connecting base of an infusion needle used in an infusion set used with pressure infusion
equipment shall employ a lock fitting.
6.10 Needle handle
The infusion needle handle shall be complete and have clear markings. The needle handle shall
share the same direction as the first bevel angle (see Fig. 1). Its slope shall be no greater than 30°.
6.11 Flexible tube
The flexible tube of the infusion needle shall be soft, transparent, bright and clean, and free of
obvious mechanical impurities, foreign matter, and kinks. It shall be transparent enough to allow
observation of bubbles and drawn blood.
6.12 Sheath
The infusion needle sheath shall not fall off on its own and shall be easy to remove.

7 Chemical requirements

7.1 Reducing substances

When testing in accordance with B.2, the difference between volumes of potassium
permanganate solution [c(KMnO4) = 0.002 mol/L] consumed by the test solution and by the blank solutions
shall not exceed 2.0 mL.
7.2 Metal ions

3
GB 18671—xxxx

When conducting an assay according to the atomic absorption spectroscopy (AAS) in B.3.1 or
according to an equivalent method, the total barium, chromium, copper, lead, and cadmium content in
the test liquid shall not exceed 1 µg/mL. The cadmium content shall not exceed 0.1 µg/mL.
When tested according to B.3.2, the colour exhibited by the test liquid shall not exceed that of the
standard control liquid having a mass concentration of (Pb2+) = 1 µg/mL.
7.3 pH
When tested according to B.4, the amount of the standard solution needed to change the
indicator colour grey shall in no case exceed 1 mL.
7.4 Evaporation residue
When tested according to B.5, the total amount of evaporation residue shall not exceed 2 mg.
7.5 Ultraviolet absorption
When tested according to B.6, the light absorption of the test liquid shall be no greater than 0.1.

8 Biological requirements

8.1 Biocompatibility
The infusion needle shall not release any substance that would cause a side effect in the patient.
GB/T 16886.1 presents a guide for biocompatibility evaluations and tests. The results of evaluations and
tests shall indicate that the infusion needle is non-toxic.
Note: The GB/T 16886 series of standards and GB/T 14233.2 present applicable biocompatibility evaluation and
test methods.
8.2 Sterility
Infusion needles in primary packaging shall undergo confirmed sterilisation processes to make the
product sterile.
Note 1: GB/T 14233.2-2005 prescribes a sterility test method, but this method cannot be used to verify the
sterilisation results of a sterilised lot.
Note 2: See GB 18279 or GB 18280 for suitable validation and routine control of the sterilisation process.
8.3 Bacterial endotoxins
When testing according to GB/T 14233.2, draw 5 mL extracting medium into a syringe and
connect it to an infusion needle. After injecting until the inner cavity of the infusion needle is full, seal the
head end of the needle. Place together in a 37 °C constant-temperature box, and extract for 1 h. Inject
the extracting medium that is remaining in the syringe through the inner cavity of the infusion needle.
Collect all of the extract fluid, and test it. The bacterial endotoxin limit shall be less than 0.5 EU/mL.

Note: YY/T 0618 presents a guide for bacterial endotoxin routine monitoring and alternating-lot inspections.

9 Labelling

9.1 Primary package

The primary package shall have at least the following information:
a) product name and chapter 4-compliant specification mark;
b) the word (or words) “sterile,” “pyrogen free,” or “bacterial endotoxin free”;
c) lot number, beginning with the word “lot”;
d) expiration date;
e) the words “for single use” or equivalent words;
f) the letter “P” indicating “pressure”; it shall be higher than the surrounding words, if applicable;
g) a warning to examine the integrity of each primary package prior to use;
h) name and address of manufacturer and/or distributor;
Note: One may use the graphic symbols presented in YY/T 0466 to meet the corresponding requirements
above.
9.2 Intermediate package
The intermediate package shall have at least the following information:
a) product name and chapter 4-compliant specification mark;
b) quantity;
c) the word (or words) “sterile,” “pyrogen free,” or “bacterial endotoxin free”;

4
 GB 18671—xxxx

d) lot number, beginning with the word “lot”;

e) expiration date;
f) the words “for single use” or equivalent words;
g) the letter “P” indicating “pressure”; it shall be higher than the surrounding words, if applicable;
h) moving, storage, and shipping requirements (when necessary);
i) name and address of manufacturer and/or distributor;
j) recommended storage conditions (if any).
Note: One may use the graphic symbols presented in YY/T 0466 to meet the corresponding requirements
above.
9.3 Shipping package
The shipping package shall have at least the following labels:
a) product name and chapter 4-compliant specification mark;
b) quantity;
c) the word (or words) “sterile,” “pyrogen free,” or “bacterial endotoxin free”;
d) lot number, beginning with the word “lot”;
f) expiration date;
g) the words “for single use” or equivalent words;
h) moving, storage, and shipping requirements (when necessary);
i) name and address of manufacturer and/or distributor;
Note: One may use the graphic symbols presented in YY/T 0466 to meet the corresponding requirements
above.

10 Packaging

Each infusion needle shall be sealed in a primary package. The materials and design of this
package shall ensure that:
a) a dialytic material is used if sterilised with ethylene oxide;
b) the infusion needle shall not be flattened or bent during packaging and sterilisation;
c) the contents of the package are identified;
d) the contents of the package are kept sterile prior to use;
e) upon opening, the contents of the package will not be easily resealable, and the act of
opening it will leave obvious traces.

5
GB 18671—xxxx

Appendix A
(Regulatory appendix)
Physical test methods

A.1 Particulate contamination test

A.1.1 Method
Proceed in accordance with the provisions of GB 8368, but prepare the eluate in accordance
with the provisions of A.1.2.
A.1.2 Preparation of eluate
Obtain 5 infusion needles to prepare eluate. Under 1 m static pressure head, cause the eluent to
flow through the 5 infusion needles, with 100 mL flowing through each needle. Collect a total of 500 mL
eluate.
Use 500 mL eluent as the blank control liquid.

A.2 Leak test

Seal an infusion needle tube and immerse in 20 °C – 30 °C water. Apply air pressure 50 kPa higher
than atmospheric pressure through the tapered hole of the connecting base for 10 sec. Examine the
infusion needle for signs of leaking air.

A.3 Flow test

A.3.1 Instrument

The flow tester is as shown in Fig. A.1.

1—air balloon with one-way valve (provided with one-way valve);

2—blood pressure gauge;
3—tube for liquid;
4—switch;
5—infusion needle supplied for test;
6—weighing container
Fig. A.1 Flow test device

6
 GB 18671—xxxx

A.3.2 Steps
In accordance with Fig. A.1, connect the infusion needle to the tester, keeping the outlet end
and the liquid surface on the same level. Use the air balloon to apply 20 kPa pressure into the system.
Measure the volume of fluid that flows from the infusion needle in 1 min.

Appendix B
(Regulatory appendix)
Methods of chemically analysing dissolved matter

B.1 Preparation of test liquid

Take 25 infusion needles. Remove the sheaths, and snip the flexible tube so that it is only 1 cm long.
Place them into glass container together with the needle tubes. Add 250 mL GB/T 6682-compliant
secondary water and maintain at a constant temperature of 37 °C ±1 °C for 2 h. Collect all liquid, and
cool to room temperature. This is the test liquid.
Put an equal volume of water in a glass container. Without loading a sample, employ the same
method to prepare the control liquid.

B.2 Reducing substance (easily oxidised substance) test

Carry out in accordance with the second method in 5.2.2 in GB/T 14233.1-XXXX.

B.3 Metal ion tests

B.3.1 Atomic absorption: Carry out in accordance with 5.9.1 in GB/T 14233.1-XXXX.
B.3.2 Colour comparison: Carry out in accordance with the first method in 5.6.1 in GB/T 14233.1-XXXX.

B.4 pH test

Carry out in accordance with 5.4.2 in GB/T 14233.1-XXXX.

B.5 Evaporation residue test

Carry out in accordance with 5.5 in GB/T 14233.1-XXXX.

B.6 Ultraviolet light absorption test

Carry out within the 250 nm to 320 nm wavelength range in accordance with 5.7 in GB/T 14233.1.

Appendix C
(Informational appendix)
Comprehensive test

C.1 The comprehensive test is a total performance test. In this test, the biocompatibility evaluation is
carried out in accordance with the requirements of GB/T 16886.1.
C.2 During the comprehensive test, randomly select and test 5 needles for each requirement in
Chapter 6, Article 9.1 and Chapter 10.
C.3 If they pass all test items, they pass the comprehensive test. Failure to pass the comprehensive test
means that batch production may not proceed.

7
GB 18671—xxxx

Appendix D
(Informational appendix)
Information relating to further evaluation of infusion needle tube and needle tip quality

D.1 Needle inner diameters used for measuring the openness to flow of needle tubes

Table D.1 presents the needle inner diameters used for measuring the openness to flow needle
tubes.
Table D.1 Inner diameters Unit: mm
Nominal outer diameter Inner diameter needle D 0-0.01
of needle tube Regular wall Thin wall Extra thin wall
0.36 0.11 0.15 --
0.4 0.15 0.19 --
0.45 0.18 0.23 --
0.5 0.18 0.23 --
0.55 0.22 0.27 --
0.6 0.25 0.29 0.30
0.7 0.30 0.35 0.37
0.8 0.40 0.42 0.44
0.9 0.48 0.49 0.50
1.1 0.58 0.60 0.68
1.2 0.70 0.73 0.83

D.2 Dimensions and nomenclature of needle tip geometric figures

Fig. D.1 presents infusion needle tip geometric shapes and labels their various dimensions.

8
 GB 18671—xxxx

Needle rotated angle of Illustrations show differences when

first
tip
d2—needle tube outer diameter;
d1—needle tube inner diameter;
A—needle tip length;
B0—first bevel nominal length;
B1—right first bevel length;
B2—left first bevel length;
C0—second bevel nominal length;
C1—right second bevel length;
bevel transversely sections needle
C2—left second bevel angle
—first bevel angle;
—second bevel angle;
—needle point angle;
1—right second bevel rotation angle;
2—left second bevel rotation angle;
—joint second bevel angle;

Fig. D.1 Infusion needle tip geometric shapes with dimensions labelled

D.3 Needle tip puncture performance test methods

D.3.1 Tester for evaluating puncture force

Fig. D.2 is a structural diagram of a typical device used to measure and record puncture force.
One may also use another device having the same performance and precision. The instrument shall
provide:
a) speed V = 50-250 mm/min, mean drive precision set drive speed ±5%;
b) 0-50 N sensor, mean precision is ±5% of full measurement range;
c) after polymeric membrane fastened, puncture area diameter is equal to 10 mm.
D.3.2 Polymeric membrane material
A polymeric membrane suitable for a puncture test will be a polyurethane membrane that is
elastic, 0.35 mm ±0.05 mm thick, with Shore A hardness of 85 ±10.
D.3.3 Puncture force evaluation test procedure
D.3.3.1 Leave the polymeric membrane at 22 °C ±2 °C for at least 24 h, and conduct the test at the same
temperature.
D.3.3.2 Vertically clamp a part of a continuous length polymeric membrane c in clamp d; protect the
polymeric membrane from tensile force. If the polymeric membrane has a finished face, orient this face
towards the needle tip.

9
GB 18671—xxxx

D.3.3.3 Load the test needle in the securing device, with its axis perpendicular to the polymeric
membrane surface and the needle tip pointing at the centre of the round area provided for puncture.
D.3.3.4 Set the travel speed at 100 mm/min.
D.3.3.5 Activate the tester.
D.3.3.6 Record the force-shift curve upon puncture of the polymeric membrane.
D.3.3.7 Measure the corresponding peak values F0, F1, F2, and F4.
D.3.3.8 Select a previously unused and unpunctured area of the polymeric membrane for each new
puncture.

Device components:
a) delivery device with force sensor e) signal amplifier
b) test needle f) data processing device
c) polymeric membrane g) plotting device
d) polymeric membrane clamping device h) magnetic cartridge storage
device

Fig. D.2 Basic structure of needle tip puncture force tester

D.3.4 Recording peak forces on coordinate diagram
One can identify various forces through observation of several typical peak values associated
with the piercing of the polymeric membrane at the moment of needle puncture.
F0: peak force when needle tip punctures polymeric membrane
F1: peak force when second plane of needle cuts across the polymeric membrane
F2: peak force when sloped edge of first plane of needle stretches polymeric membrane
F4: friction peak value along length of needle tube when passing through polymeric membrane
Note: When this test is used for puncture force tests of trocar catheters, use F3 to indicate the peak force when
the catheter stretches the polymeric membrane; F4 indicates the friction peak force along the length of the catheter
when passing through the polymeric membrane.
Fig. D.3 presents a coordinate diagram containing the typical needle puncture forces F0, F1, F2,
and F4.

10
 GB 18671—xxxx

Fig. D.3 Coordinate diagram showing typical infusion needle puncture forces

D.3.5 Representation of results

Evaluate measurement-based force-shift coordinate diagrams through graphic comparisons with
needles (having known quality performance) of the same type.

Reference Literature

[1] GB 15593-2007 Soft polyvinyl chloride (PVC) plastic for infusion (transfusion) equipment
[2] GB 15811-2000 Sterile hypodermic needles for single use
[3] GB/T 16886 (all parts) Biological evaluation of medical devices
[4] GB 18279 Medical devices—Validation and routine control of ethylene oxide sterilisation
[5] GB 18280 Sterilisation of health care products—Requirements for validation and routine control—
Radiation sterilisation
[6] YY 0466 Medical devices—Symbols to be used with medical device labels, marks, and supplied
information
[7] YY/T 0618 Methods of testing bacterial endotoxins—Routine monitoring and alternating-lot inspections