GB 18671-2009 PDF English
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| GB 18671-2009 | English | 85 |
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Intravenous needles for single use
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| GB 18671-2002 | English | 639 |
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Intravenous needles for single use
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GB 18671-2009: Intravenous needles for single use---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GB18671-2009
GB
NATIONAL STANDARD OF
THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
Replacing GB 18671-2002
Intravenous needles for single use
Issued on. MAY 6, 2009
Implemented on. MARCH 1, 2010
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration Committee.
Table of Contents
Foreword... 3
Introduction... 5
1 Scope... 6
2 Normative references... 6
3 Structure and naming... 7
4 Examples of marking... 8
5 Materials... 8
6 Physical requirements... 8
7 Chemical requirements... 11
8 Biological requirements... 11
9 Marks... 12
10 Packaging... 14
Annex A... 15
Annex B... 17
Annex C... 18
Annex D... 19
References... 24
Foreword
All technical content of this Standard is mandatory.
This Standard replaces GB 18671-2002 “Intravenous infusion needles for
single use.” The main differences between this Standard and GB 18671-2002
are as follows.
- the applicable scope was expanded to infusion needles for. gravity feed-
type infusion sets, infusion sets used with pressure infusion equipment,
and transfusion sets; 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;
- re-categorized the requirement relating to inner diameter for quick
evaluation of needle tube openness to flow; it is now a requirement in
informational Annex form for further evaluation of needle tube and needle
tip quality; eliminated the qualitative needle tip puncture force test
methods;
- changed pH test to titrimetric method;
- eliminated the ethylene oxide residue quantity requirement for infusion
needles sterilized with ethylene oxide; added a requirement that
packaging make use of dialytic materials;
- revised mark and packaging requirements;
- eliminated the exit-factory inspection.
Annex A and Annex B of this Standard are normative. Annex C and Annex D
are informative.
This Standard was proposed by China State Food and Drug Administration.
This Standard shall be under the jurisdiction of China National Technical
Committee on Standardization of Medical Infusion Devices.
Drafting organizations of this Standard. Zhejiang Kangdelai Medical Apparatus
Stock Co., Ltd., Jinan Quality Supervision and Inspection Centre for Medical
Devices of China State Food and Drug Administration.
Main drafters of this Standard. Zhang Honghui, Song Jinzi, Wu Ping, Jia Fei.
This Standard replaces the following previous version.
- GB 18671-2002.
Introduction
There are two main forms in which intravenous infusion needles are supplied.
One is supplied to hospitals together with infusion and transfusion sets.; the
other is supplied to hospitals as independent commercial products. The first
one accounts for the great majority of such needles in China. The sterility,
packaging, and labelling requirements of this Standard do not apply to
intravenous infusion needles supplied together with infusion and transfusion
sets.
To meet different clinical needs, this 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, this 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.
Intravenous needles for single use
1 Scope
This Standard specifies requirements for single-use intravenous infusion
needles (hereinafter referred to as “infusion needles”) of which the nominal
outer diameter is 0.36 mm ~ 1.2 mm to ensure adaptability to gravity feed-type
infusion sets, infusion sets used with pressure infusion equipment, and
transfusion sets.
This Standard provides a guide to the properties and quality norms for the
materials used in infusion needles.
Clause 3 to 8.1, and 8.3 of Clause 8 of this Standard give quality norms for
infusion needles supplied with infusion and transfusion sets.
2 Normative references
The following standards contain the provisions which, through reference in this
Standard, constitute the provisions of this Standard. For dated references,
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this 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)
3 Structure and naming
Figure 1 shows the structure, names of parts, and needle tube length (L) of a
typical infusion needle.
4 Examples of marking
4.1 Infusion needle specification mark is presented in terms of needle tube
nominal diameter, nominal length, tube wall type, and angle (α) of first bevel of
needle tip. The outer diameter and length are expressed in “mm”.
4.2 For an infusion needle that is compliant with This 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.
5 Materials
The needle tubing used to manufacture infusion needles shall comply with the
requirements of GB 18457.
6 Physical requirements
6.1 Color labelling
The color 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 color shall
comply with the requirements of YY/T 0296.
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.
6.4 Leakage
The inner cavity of the infusion needle shall have a good seal. It shall not leak
when tested in accordance with Clause A.2.
Infusion needles used together with infusions sets used with pressure infusion
equipment shall comply with the requirements in 6.3 of YY0286.4-2006.
6.5 Flow
When tested in accordance with Clause A.3, the outflow of water under 20 kPa
pressure shall be no lower than what is specified in Table 1.
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 Figure 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.
6.8 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.
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.
6.11 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.
7 Chemical requirements
7.1 Reducing substances
When testing in accordance with Clause 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
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.
7.3 pH
When tested according to Clause B.4, the amount of the standard solution
needed to change the indicator color grey shall in no case exceed 1 mL.
7.4 Evaporation residue
When tested according to Clause B.5, the total amount of evaporation residue
shall not exceed 2 mg.
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.
8.2 Sterility
Infusion needles in primary packaging shall undergo confirmed sterilization
processes to make the product sterile.
8.3 Bacterial endotoxins
When testing according to GB/T 14233.2, draw 5 mL of 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.
9 Marks
9.1 Primary package
The primary package shall have at least the following information.
9.2 Intermediate package
The intermediate package shall have at least the following information.
9.3 Shipping package
The shipping package shall have at least the following labels.
10 Packaging
Each infusion needle shall be sealed in a primary package. The materials and
design of this package shall ensure that.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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