| ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 11-226 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Orthopedic |
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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 general test procedures and evaluation criteria for the corrosion resistance of surgical instruments intended for reuse in surgery and fabricated from stainless steel such as, but not limited to, those listed in Specification F899.
1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable (Class 5), and ferritic (Class 6) materials shall use the boil test.
1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable (Class 5) materials shall use the boil test and the copper sulfate test.
1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide on the surface of materials.
1.5 The copper sulfate test is not recommended for martensitic materials. (See Note X1.1.)
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenable materials to detect free iron or any other anodic surface contaminants on stainless steel.
| Regulation Number | Device Name | Device Class | Product Code |
| §888.4800 | Template | Class 1 | HWT |
| §888.4540 | Applier, Cerclage | Class 1 | HXN |
| §888.4540 | Awl | Class 1 | HWJ |
| §888.4540 | Bender | Class 1 | HXW |
| §888.4540 | Bit, Drill | Class 1 | HTW |
| §888.4540 | Brace, Drill | Class 1 | HXY |
| §888.4540 | Broach | Class 1 | HTQ |
| §888.4540 | Burr, Orthopedic | Class 1 | HTT |
| §888.4540 | Corkscrew | Class 1 | HWI |
| §888.4540 | Countersink | Class 1 | HWW |
| §888.4540 | Crimper, Pin | Class 1 | HXQ |
| §888.4540 | Cutter, Wire | Class 1 | HXZ |
| §888.4540 | Driver, Prosthesis | Class 1 | HWR |
| §888.4540 | Extractor | Class 1 | HWB |
| §888.4540 | File | Class 1 | HTP |
| §888.4540 | Holder, Needle; Orthopedic | Class 1 | HXK |
| §888.4540 | Impactor | Class 1 | HWA |
| §888.4540 | Instrument, Bending Or Contouring | Class 1 | HXP |
| §888.4540 | Instrument, Compression | Class 1 | HWN |
| §888.4540 | Knife, Orthopedic | Class 1 | HTS |
| §888.4540 | Orthopedic Manual Surgical Instrument | Class 1 | LXH |
| §888.4540 | Passer | Class 1 | HWQ |
| §888.4540 | Passer, Wire, Orthopedic | Class 1 | HXI |
| §888.4540 | Positioner, Socket | Class 1 | KIL |
| §888.4540 | Probe | Class 1 | HXB |
| §888.4540 | Punch, Femoral Neck | Class 1 | HWP |
| §888.4540 | Pusher, Socket | Class 1 | HXO |
| §888.4540 | Reamer | Class 1 | HTO |
| §888.4540 | Rongeur | Class 1 | HTX |
| §888.4540 | Scissors, Orthopedic, Surgical | Class 1 | HRR |
| §888.4540 | Screwdriver | Class 1 | HXX |
| §888.4540 | Set, Hollow Mill | Class 1 | HWL |
| §888.4540 | Skid, Bone | Class 1 | HWO |
| §888.4540 | Staple Driver | Class 1 | HXJ |
| §888.4540 | Starter, Bone Screw | Class 1 | HWD |
| §888.4540 | Stripper, Surgical | Class 1 | HRT |
| §888.4540 | Tamp | Class 1 | HXG |
| §888.4540 | Tap, Bone | Class 1 | HWX |
| §888.4540 | Trephine | Class 1 | HWK |
| §888.4540 | Twister, Wire | Class 1 | HXS |
| §888.4540 | Wrench | Class 1 | HXC |
| §888.4300 | Gauge, Depth | Class 1 | HTJ |
| §888.3050 | Accessories, Fixation, Spinal Interlaminal | Class 2 | LYP |
| §878.4820 | Guide, Drill, Ligament | Class 1 | LXI |
| §888.4540 | Accessories, Fixation, Spinal Intervertebral Body | Class 1 | LYQ |
| There is no relevant guidance developed at this time. |