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ISO 9626:2016

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

Pages: 30
Publication date: 2016-08-01
Price: 138 vnd

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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.
Document identifier
ISO 9626:2016
Title
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO Category
TC 84: Devices for administration of medicinal products and intravascular catheters
Publication date
2016-08-01
Status
Effective
International Relationship
DIN EN ISO 9626 * BS EN ISO 9626:2016
Cross references
Latest version
ISO 9626:2016
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
Document identifier ISO 9626:2016
Publication date 2016-08-01
Classification 11.040.25. Syringes, needles and catheters
Status Effective
*
History of version
ISO 9626:2016 * ISO 9626:1991
Keywords
Pages
30
Price 138 vnd