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GB 18671-2009 English PDF (GB18671-2009)

GB 18671-2009 English PDF (GB18671-2009)

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GB 18671-2009: Intravenous needles for single use

This Standard specifies requirements for single-use intravenous 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.
GB 18671-2009
GB
NATIONAL STANDARD OF
THE PEOPLE 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.
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)
GB/T 14233.1 Infusion, transfusion, and injection equipment for medical use - Part 1. Chemical analysis methods
7 - needle tube outer diameter specification c;
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. Figure 1 shows the typical structure of an infusion needle. Another structure may be adopted so long as the same results are achieved.
Figure 1 Example of 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 (??) 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 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.
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 Clause D.1.
Note 2. This Standard recommends use of thin-wall or extra-thin-wall needle tubes. 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 Clause 7 and Clause 8.
6 Physical requirements
6.1 Color labelling
8.2 Sterility
Infusion needles in primary packaging shall undergo confirmed sterilization 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 sterilization results of a sterilized lot.
Note 2. See GB 18279 or GB 18280 for suitable validation and routine control of the sterilization process.
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. 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 Marks
9.1 Primary package...

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