ISO 9626:2016 pdf free

ISO 9626:2016 pdf free.Stainless steel needle tubing for the manufacture of medical devices一Requirements and test methods
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.
ISO 9626 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.
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3696, Water for analytical laboratory use一Specification and test methods
ISO 15510, Stainless steels一Chemical composition
When tested in accordance with Annex B, the tubing shall show a deflection not greater than the relevant value given in Table 2.
When examined by normal or corrected vision, the surfaces of the tubing shall be free from metal soil and processing agents.
Cleanliness specifications may be different based on the final function of the medical device; in such cases, the medical device manufacturer should prepare specific specifications for cleanliness.
For tubes where stiffness test parameters are not defined in this International Standard, the medical device manufacturer shall prepare specific stiffness requirements based on a risk assessment of the final intended use of the tube.
Consideration should be given to the final product intended use of the tube to determine if additional tests are required.ISO 9626 pdf download.