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GB 18457-2001 (GB18457-2001)

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GB 18457-2001: PDF in English
GB 18457-2001
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
C 31
eqv ISO 9626:1991
Stainless steel needle tubing for manufacture of
medical devices
Replaced
ISSUED ON: SEPTEMBER 18, 2001
IMPLEMENTED ON: FEBRUARY 01, 2002
Issued by: General Administration of Quality Supervision, Inspection
and Quarantine of the People's Republic of China
Table of Contents
Foreword ... 3 
ISO Foreword ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Materials ... 5 
4 Dimensions ... 6 
5 Size designation ... 6 
6 Surface ... 7 
7 Cleanliness ... 7 
8 Limits for acidity and alkalinity ... 7 
9 Stiffness ... 7 
10 Resistance to breakage ... 8 
11 Resistance to corrosion ... 8 
Annex A (Normative) Method of preparation of extracts ... 9 
Annex B (Normative) Determination of acidity or alkalinity of tubing ... 10 
Annex C (Normative) Test method for stiffness of tubing ... 11 
Annex D (Normative) Test method for resistance of tubing to breakage ... 13 
Annex E (Normative) Test method for resistance to corrosion ... 14 
Annex F (Informative) Stainless steel designation ... 15 
Foreword
This Standard is equivalent to the use of ISO 9626: 1991, Stainless steel needle
tubing for the manufacture of medical devices.
The main technical differences between this Standard and ISO 9626:1991 are
as follows:
For material requirements, the standard ISO 9626: 1991 adopts the
designations in ISO 683-13: 1986, Heat-treatable steels, alloy steels and free-
cutting steels - Part 13: Wrought stainless steels; this Standard adopts the
stainless steel designations equivalent to the requirements of ISO 9626: 1991,
Stainless steels - Chemical composition, and adds provisions for the
manufacture of other austenitic stainless steel materials equivalent to the
designations given in this Standard. Equivalent designations are given in the
informative annex. In the table of dimensions of tubing, it eliminates the
requirements for the maximum inner diameter of normal-, thin- and extra-thin-
walled tubing, and adds Gauge wire gauge specifications (for reference only).
For the determination of acidity or alkalinity of tubing, the international standard
uses the Tashiro titration method; this Standard uses the method 1 (Acid
method) in GB/T 14233.1-1998.
Annexes A, B, C, D and E of this Standard are normative annexes.
Annex F of this Standard is an informative annex.
This Standard was proposed by National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee
95 on Injector for Medical Purpose of Standardization Administration of China.
The drafting organization of this Standard: Zhejiang Kangdelai Medical
Machinery Plastic Co., Ltd.
The drafters of this Standard: Zhang Honghui, Tang Zengji.
Stainless steel needle tubing for manufacture of
medical devices
1 Scope
This Standard specifies the dimensions, surface and mechanical properties of
normal and thin-walled tubing of designated metric sizes 0.3 mm to 3.4 mm,
and of extra-thin-walled tubing of designated metric sizes 0.6 mm to 2.1 mm.
This Standard applies to rigid stainless-steel needle tubing suitable for use in
the manufacture of intradermal, hypodermic, intramuscular injection needles
and other medical devices primarily for human use (hereinafter referred to as
tubing).
This Standard does not apply to flexible stainless-steel tubing because the
mechanical properties differ from those specified for rigid tubing in this Standard.
However, manufacturers and purchasers of flexible tubing are encouraged to
adopt the dimensional specifications given in this Standard.
2 Normative references
The following standards contain provisions which, through reference in this text,
constitute provisions of this Standard. At the time of publication, the editions
indicated were valid. All standards are subject to revision, and parties to
agreements based on this Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below.
GB 6682-1992, Water for analytical laboratory use - Specification and test
method (neq ISO 3696:1987)
GB/T 14233.1-1998, Infusion, transfusion, injection equipment for medical
use - Part 1: Chemical analysis methods
ISO/TR 15510:1997, Stainless steel - Chemical composition
3 Materials
Tubing shall be made from austenitic stainless steels, such as X2CrNi18-9,
X5CrNi18-9, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2,
X6CrNiMoNb17-12-2 in accordance with ISO/TR 15510:1997, or made from
other austenitic stainless steels equivalent to the above stainless steels.
Annex D 
(Normative) 
Test method for resistance of tubing to breakage
D1 Principle
One end of the tubing is firmly fixed, and a force applied to the tubing at a
specified distance from the point of fixation, so as to bend the tubing through a
specified angle, first in one direction and then in the opposite direction, for a
specified number of cycles.
D2 Apparatus
D2.1 Support and device for fixing the tubing.
D2.2 The equipment can apply a sufficient force to the needle tubing, so that it
can bend three angles of 25°, 20°, and 15° on the same plane from the forward
and reverse directions.
D3 Test procedure
D3.1 Rigidly fix one end of the tubing in the support (D2.1); adjust the specified
span corresponding to the tested tubing, and select the following bending angle
according to Table 3, normal walled -- 25°, thin walled -- 20°, extra-thin-walled
-- 15°.
D3.2 Apply a sufficient force at the specified span position; apply the force 20
times in two directions at a frequency of 0.5 Hz, and visually observe the tubing
breakage.
D4 Test report
The test report shall contain at least the following information:
a) the designated metric size and description of the tubing;
b) the wall type of the tubing: normal-, thin-, or extra-thin-walled;
c) tubing breakage during the test and determination results;
d) the date of testing.
Annex E 
(Normative) 
Test method for resistance to corrosion
E1 Principle
The tubing is partially immersed in sodium chloride solution for a specified time
and afterwards the immersed portion compared visually with the unimmersed
portion for signs of corrosion.
E2 Apparatus and reagents
E2.1 Solution of sodium chloride
Use distilled or deionized water of grade 3 in accordance with GB 6682-1992.
Prepare c(NaCl) = 0.5 mol/L (analytical grade reagent) solution.
E2.2 Selection of laboratory borosilicate glassware.
E3 Test procedure
Place a piece of needle tubing in a glass vessel (E2.2) containing sodium
chloride solution (E2.1) at 23 °C ±2 °C, so that approximately half the length of
the tubing is immersed. Maintain the liquid and tubing at 23 °C ± 2 °C for 7 h ±
5 min. Remove the needle tubing; use distilled water or deionized water to wipe
it dry; compare the immersed and unimmersed portions under normal or
corrected vision for signs of corrosion caused by the immersion.
E4 Test report
The test report shall contain at least the following information:
a) the description and designated metric size of the tubing;
b) the wall type of the tubing: normal-, thin-, or extra-thin-walled;
c) whether corrosion occurred on the immersed half during the test;
d) the date of testing.
......