| ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments |
| Recognition Number | Materials |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 8-478 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | Materials |
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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 new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.
1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.
1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.
1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or 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 published at this time. |