NEN-EN-ISO 9626

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

active, Most Current
Organization: NEN
Publication Date: 1 September 2016
Status: active
Page Count: 39
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

NEN-EN-ISO 9626 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This International Standard 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. This International Standard 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 this International Standard. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in this International Standard.

Document History

NEN-EN-ISO 9626
September 1, 2016
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
NEN-EN-ISO 9626 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use. This International Standard...
July 1, 2001
Stainless steel needle tubing for the manufacture of medical devices
A description is not available for this item.
March 1, 2000
Stainless steel needle tubing for the manufacture of medical devices
A description is not available for this item.
April 1, 1995
Stainless steel needle tubing for the manufacture of medical devices
Specifies de dimensions, surface and mechanical properties of normal- and thin-walled tubing of designated metric sizes 3,4 mm to 0,3 mm, and of extra-thin-walled tubing of designated metric sizes...
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