ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.
It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
5.1 General
5.2 Surface finish and visual appearance
5.3 Cleanliness
5.4 Limits for acidity and alkalinity
5.5 Size designation
5.6 Dimensions
5.7 Sample size
5.8 Stiffness
5.9 Resistance to breakage
5.10 Resistance to corrosion
Annex A (normative) Methods for preparation of extracts
Annex B (normative) Test method for stiffness of tubing
Annex C (normative) Test method for resistance of tubing to breakage
Annex D (normative) Test method for resistance to corrosion
Annex E (informative) Rationale with respect to test method for stiffness of tubing
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials
5 Requirements
5.1 General
5.2 Surface finish and visual appearance
5.3 Cleanliness
5.4 Limits for acidity and alkalinity
5.5 Size designation
5.6 Dimensions
5.7 Sample size
5.8 Stiffness
5.9 Resistance to breakage
5.10 Resistance to corrosion
Annex A (normative) Methods for preparation of extracts
Annex B (normative) Test method for stiffness of tubing
Annex C (normative) Test method for resistance of tubing to breakage
Annex D (normative) Test method for resistance to corrosion
Annex E (informative) Rationale with respect to test method for stiffness of tubing
Bibliography