| ASTM F1874-98 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 6-271 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Long Chen FDA/OMPT/CDRH/ODE/DSD/GSDB2/ 301-796-6389 long.chen@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 describes the procedure for bend testing needles used for the placement of surgical sutures.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
| Regulation Number | Device Name | Device Class | Product Code |
| §882.4650 | Needle, Neurosurgical Suture | Class 1 | HAS |
| §878.4800 | Needle, Suturing, Disposable | Class 1 | GAB |
| §878.4800 | Needle, Suturing, Reusable | Class 1 | GDL |
| There is no relevant guidance developed at this time. |