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Normas DIN – AENOR
DIN EN ISO 9626:2015-03

DIN EN ISO 9626:2015-03

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO/DIS 9626:2015); German version prEN ISO 9626:2015 / Note: Date of issue 2015-02-27

Tubes d´aiguilles en acier inoxydable pour la fabrication de matériel médical (ISO/DIS 9626:2015); Version allemande prEN ISO 9626:2015 / Attention: Date de parution 2015-02-27

Kanülenrohre aus nichtrostendem Stahl zur Herstellung von Medizinprodukten - Anforderungen und Prüfverfahren (ISO/DIS 9626:2014); Deutsche Fassung prEN ISO 9626:2015 / Achtung: Erscheinungsdatum 2015-02-27

Fecha Anulación:
2016-12 /Withdrawn
Equivalencias internacionales:

ISO/DIS 9626 (2015-01)

prEN ISO 9626 (2015-01)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 9626:2016-12

Resumen:
This Draft International Standard provides requirements and test methods for the tube 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 document specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (G10) to 0,18 mm (G34). This International Standard 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 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.
Keywords:
Cannulas, Definitions, Dimensions, Finishes, Hypodermic needles, Materials, Mechanical properties, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Pipes, Properties, Specifications, Stainless steels, Steel tubes, Steels, Syringes, Testing, Testing conditions
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