| ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| Recognition Date | 2016-09-21 |
| Recognition List | 045 |
| Recognition Number | 6-380 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Oleg Vesnovsky FDA/OMPT/CDRH/OSEL/DAM/ 301-796-2527 oleg.vesnovsky@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 s 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5725 | Pump, Infusion | Class 2 | FRN |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| There is no relevant guidance developed at this time. |