| ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 6-400 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.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.
1.1 This test method covers the qualitative measurement of Huber-type needles' potential to remove septum material during implantable port access (1)2.
1.2 This test method does not address other issues that may include, but are not limited to, force measurement during the perforation/withdrawal, septum integrity, and any safety issues.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5570 | Needle, Hypodermic, Single Lumen | Class 2 | FMI |
| There is no relevant guidance developed at this time. |