ISO-9626 › Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
The following bibliographic material is provided to assist you with your purchasing decision:
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.
To find similar documents by classification:
11.040.25 (Syringes, needles and catheters)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-F1980
Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
Document Number
ISO 9626:2016
Revision Level
2ND EDITION
Status
Current
Publication Date
Aug. 1, 2016
Committee Number
ISO/TC 84