| ASTM F2062-00 (Reapproved 2011) Standard Specification for Square Drive Interconnections on Surgical Instruments |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 6-272 |
| 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 specification applies to interconnections of surgical instruments used for drilling, tapping, driving, or placing of medical devices during surgery.
1.2 This specification includes dimensions and tolerances for both driving and driven elements.
1.3 The specifications given in ASME B107.4M-1995 are designed for industrial applications and are considered too loose for surgical applications. Springs used for industrial applications are generally made from carbon steel and are capable of higher loads than their stainless steel counterparts. The specifications given in this standard have been written to lessen the chance of accidental disengagement of surgical instruments. This accidental disengagement could injure the patient or end user, or damage or contaminate the instrument.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.4540 | Bit, Drill | Class 1 | HTW |
| §878.4800 | Mercy Tape 2d And 3d Models | Class 1 | PIR |
| §878.4800 | Orthopedic Tray | Class 1 | OJH |
| §878.4800 | Disposable Joint Aspiration/Injection Kit | Class 1 | PPP |
| §878.4800 | Needle, Biopsy, Cardiovascular | Class 1 | DWO |
| §878.4800 | Knife, Surgical | Class 1 | EMF |
| §878.4800 | Apparatus, Suturing, Stomach And Intestinal | Class 1 | FHM |
| §878.4800 | Needle, Gastro-Urology | Class 1 | FHR |
| §878.4800 | Lancet, Blood | Class 1 | FMK |
| §878.4800 | Tray, Surgical, Needle | Class 1 | FSH |
| §878.4800 | Tray, Surgical, Instrument | Class 1 | FSM |
| §878.4800 | Loupe, Diagnostic/Surgical | Class 1 | FSP |
| §878.4800 | Mirror, General & Plastic Surgery | Class 1 | FTX |
| §878.4800 | Tape, Measuring, Rulers And Calipers | Class 1 | FTY |
| §878.4800 | Chisel, Surgical, Manual | Class 1 | FZO |
| §878.4800 | Contractor, Surgical | Class 1 | FZR |
| §878.4800 | Curette, Surgical, General Use | Class 1 | FZS |
| §878.4800 | Cutter, Surgical | Class 1 | FZT |
| §878.4800 | Expander, Surgical, Skin Graft | Class 1 | FZW |
| §878.4800 | Guide, Surgical, Instrument | Class 1 | FZX |
| §878.4800 | Hammer, Surgical | Class 1 | FZY |
| §878.4800 | Needle, Aspiration And Injection, Disposable | Class 1 | GAA |
| §878.4800 | Needle, Suturing, Disposable | Class 1 | GAB |
| §878.4800 | Rasp, Surgical, General & Plastic Surgery | Class 1 | GAC |
| §878.4800 | Retractor | Class 1 | GAD |
| §878.4800 | Snare, Surgical | Class 1 | GAE |
| §878.4800 | Spatula, Surgical, General & Plastic Surgery | Class 1 | GAF |
| §878.4800 | Stapler, Surgical | Class 1 | GAG |
| §878.4800 | Stylet, Surgical, General & Plastic Surgery | Class 1 | GAH |
| §878.4800 | Stripper, Vein, Reusable | Class 1 | GAI |
| §878.4800 | Stripper, Vein, Disposable | Class 1 | GAJ |
| §878.4800 | Retainer, Surgical | Class 1 | GCZ |
| §878.4800 | Guide, Needle, Surgical | Class 1 | GDF |
| §878.4800 | Hook, Surgical, General & Plastic Surgery | Class 1 | GDG |
| §878.4800 | Gouge, Surgical, General & Plastic Surgery | Class 1 | GDH |
| §878.4800 | Dissector, Surgical, General & Plastic Surgery | Class 1 | GDI |
| §878.4800 | Clamp, Surgical, General & Plastic Surgery | Class 1 | GDJ |
| §878.4800 | Needle, Suturing, Reusable | Class 1 | GDL |
| §878.4800 | Needle, Aspiration And Injection, Reusable | Class 1 | GDM |
| §878.4800 | Knife, Amputation | Class 1 | GDN |
| §878.4800 | Applier, Surgical, Clip | Class 1 | GDO |
| §878.4800 | Saw, Manual And Accessories | Class 1 | GDR |
| §878.4800 | Scalpel, One-Piece | Class 1 | GDX |
| §878.4800 | Handle, Scalpel | Class 1 | GDZ |
| §878.4800 | Cannula, Surgical, General & Plastic Surgery | Class 1 | GEA |
| §878.4800 | Brush, Scrub, Operating-Room | Class 1 | GEC |
| §878.4800 | Brush, Dermabrasion, Manual | Class 1 | GED |
| §878.4800 | Brush, Biopsy, General & Plastic Surgery | Class 1 | GEE |
| §878.4800 | Applier, Staple, Surgical, | Class 1 | GEF |
| §878.4800 | Elevator, Surgical, General & Plastic Surgery | Class 1 | GEG |
| §878.4800 | Carrier, Ligature | Class 1 | GEJ |
| §878.4800 | Forceps, General & Plastic Surgery | Class 1 | GEN |
| §878.4800 | File, Surgical, General & Plastic Surgery | Class 1 | GEO |
| §878.4800 | Blade, Scalpel | Class 1 | GES |
| §878.4800 | Osteotome, Manual | Class 1 | GFI |
| §878.4800 | Mallet, Surgical, General & Plastic Surgery | Class 1 | GFJ |
| §878.4800 | Applier, Hemostatic Clip | Class 1 | HBT |
| §878.4800 | Instrument, Ligature Passing And Knot Tying | Class 1 | HCF |
| §878.4800 | Hemostat | Class 1 | HRQ |
| §878.4800 | Saw | Class 1 | HSO |
| §878.4800 | Pliers, Surgical | Class 1 | HTC |
| §878.4800 | Forceps | Class 1 | HTD |
| §878.4800 | Elevator | Class 1 | HTE |
| §878.4800 | Curette | Class 1 | HTF |
| §878.4800 | Rasp | Class 1 | HTR |
| §878.4800 | Instrument, Cutting, Orthopedic | Class 1 | HTZ |
| §878.4800 | Osteotome | Class 1 | HWM |
| §878.4800 | Clamp | Class 1 | HXD |
| §878.4800 | Mallet | Class 1 | HXL |
| §878.4800 | Spatula, Orthopedic | Class 1 | HXR |
| §878.4800 | Tape, Orthopedic | Class 1 | HXT |
| §878.4800 | Forceps, Wire Holding | Class 1 | HYA |
| §878.4800 | Cannula, Ear | Class 1 | JYC |
| §878.4800 | Chisel, Mastoid | Class 1 | JYD |
| §878.4800 | Cannula, Sinus | Class 1 | KAM |
| §878.4800 | Chisel, Nasal | Class 1 | KAN |
| §878.4800 | Cannulae, Bronchial | Class 1 | KCE |
| §878.4800 | Instrument, Surgical, Disposable | Class 1 | KDC |
| §878.4800 | Kit, Surgical Instrument, Disposable | Class 1 | KDD |
| §878.4800 | Hook, Bone | Class 1 | KIK |
| §878.4800 | Tray, Surgical | Class 1 | LRP |
| §878.4800 | Scissors, General, Surgical | Class 1 | LRW |
| §878.4800 | Punch, Surgical | Class 1 | LRY |
| §878.4800 | Screwdriver, Surgical | Class 1 | LRZ |
| §878.4800 | Vise, Bench, Surgical | Class 1 | LSA |
| §878.4800 | Razor, Surgical | Class 1 | LWK |
| §878.4800 | Scrapper, Skin Specimen | Class 1 | LXK |
| §878.4800 | Guard, Instrument | Class 1 | LXZ |
| §878.4800 | Label Or Tag, Sterile | Class 1 | LYV |
| §878.4800 | Suture Removal Kit | Class 1 | MCZ |
| §878.4800 | Instrument, Manual, Surgical, General Use | Class 1 | MDM |
| §878.4800 | Needle, Tumor Localization | Class 1 | MIJ |
| §878.4800 | Device, Percutaneous, Biopsy | Class 1 | MJG |
| §878.4800 | Extractor, Vein | Class 1 | NJZ |
| §878.4800 | Needle, Biopsy, Cardiovascular, Reprocessed | Class 1 | NLK |
| §878.4800 | Needle, Gastro-Urology, Reprocessed | Class 1 | NMU |
| §878.4800 | Biopsy Device, Percutaneous, Reprocessed | Class 1 | NNA |
| §878.4800 | Needle, Aspiration And Needle, Reprocessed | Class 1 | NNC |
| §878.4800 | Aspiration Tray | Class 1 | OJT |
| §878.4800 | Skin Prep Tray | Class 1 | OJU |
| §878.4800 | Single Use Instrument Tray | Class 1 | OJV |
| §878.4800 | Laparoscopic Cholecystectomy Kit | Class 1 | PKE |
| §878.4800 | Basic Set-Up Tray | Class 1 | PXN |
| §878.4800 | Bone Marrow Biopsy Tray | Class 1 | PXO |
| §878.4800 | Breast Biopsy / Localization Tray | Class 1 | PXP |
| §878.4800 | Cholecystectomy Kit | Class 1 | PXS |
| §878.4800 | General Purpose Instrument Tray | Class 1 | PXV |
| §878.4800 | Herniorraphy Kit | Class 1 | PXW |
| §878.4800 | Incision Tray | Class 1 | PXX |
| §878.4800 | Laparascopic Sphincterotomy Kit | Class 1 | PXZ |
| §878.4800 | Liver Biopsy Kit | Class 1 | PYA |
| §878.4800 | Minor Surgical Procedures Tray | Class 1 | PYB |
| §878.4800 | Pelviscopy Kit | Class 1 | PYD |
| §878.4800 | Sterile Puncture Tray | Class 1 | PYF |
| §878.4800 | Surgical Retractor Kit | Class 1 | PYH |
| No product code information listed for §878.4540 | |||
| §876.4730 | Surgical Instruments, G-U, Manual (And Accessories) | Class 1 | KOA |
| There is no relevant guidance developed at this time. |