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 (hereinafter referred to as “tubing”) suitable for use in the manufacture of intradermal, hypodermic and muscle needles and other medical devices primarily for human use.
It 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 Methods (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 Steels - Chemical Composition
3 Materials
The tubing shall be made from austenitic stainless steels in conformity with ISO/TR 15510: 1997, such as X2CrNi18-9, X5CrNi18-9, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2 and X6CrNiMoNb17-12-2 or other equivalent austenitic stainless steels.
4 Dimensions
The outside diameter, inside diameter and dimensions of tubing shall comply with those specified in in Table 1.
Foreword i ISO Foreword i 1 Scope 2 Normative References 3 Materials 4 Dimensions 5 Size Designation 6 Surface 7 Cleanliness 8 PH Value 9 Stiffness 10 Toughness 11 Resistance to Corrosion Annex A (Normative) Preparation Method for Tested Liquid Annex B (Normative) Test Method for PH Value of Tubing Annex C (Normative) Test Method for Stiffness of Tubing Annex D (Normative) Test Method for Toughness of Tubing Annex E (Normative) Test Method for Resistance to Corrosion Annex F (Informative) Stainless Steel Designation
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 (hereinafter referred to as “tubing”) suitable for use in the manufacture of intradermal, hypodermic and muscle needles and other medical devices primarily for human use.
It 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 Methods (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 Steels - Chemical Composition
3 Materials
The tubing shall be made from austenitic stainless steels in conformity with ISO/TR 15510: 1997, such as X2CrNi18-9, X5CrNi18-9, X6CrNiNb18-10, X5CrNiMo17-12-2, X6CrNiMoTi17-12-2 and X6CrNiMoNb17-12-2 or other equivalent austenitic stainless steels.
4 Dimensions
The outside diameter, inside diameter and dimensions of tubing shall comply with those specified in in Table 1.
Contents of GB 18457-2001
Foreword i
ISO Foreword i
1 Scope
2 Normative References
3 Materials
4 Dimensions
5 Size Designation
6 Surface
7 Cleanliness
8 PH Value
9 Stiffness
10 Toughness
11 Resistance to Corrosion
Annex A (Normative) Preparation Method for Tested Liquid
Annex B (Normative) Test Method for PH Value of Tubing
Annex C (Normative) Test Method for Stiffness of Tubing
Annex D (Normative) Test Method for Toughness of Tubing
Annex E (Normative) Test Method for Resistance to Corrosion
Annex F (Informative) Stainless Steel Designation
