EN ISO 9626:2016

Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) EN ISO 9626:2016

Publication date:   Dec 15, 2016

General information

60.60 Standard published   Aug 31, 2016

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.25   Syringes, needles and catheters

Buying

Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 9626:1995

WITHDRAWN
EN ISO 9626:1995/A1:2001

NOW

PUBLISHED
EN ISO 9626:2016
60.60 Standard published
Aug 31, 2016