ASTM F1078-10 (Reapproved 2011) Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
Recognition Date | 2012-03-16 |
Recognition List | 028 |
Recognition Number | 6-269 |
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 terminology defines basic terms and considerations for the components of scissors with either inserted or non-inserted blades (see Fig. 1). Instruments in this terminology are limited to those fabricated having scissor blades made from stainless steel and used for surgical procedures.
Regulation Number | Device Name | Device Class | Product Code |
§888.4540 | Scissors, Orthopedic, Surgical | Class 1 | HRR |
§880.6820 | Scissors, Medical, Disposable | Class 1 | JOK |
§878.4800 | Scissors, General, Surgical | Class 1 | LRW |
§872.4565 | Scissors, Surgical Tissue, Dental | Class 1 | EGN |
There is no relevant guidance developed at this time. |