| ISO 7153-1 Second edition 1991-04-01 Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 8-344 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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.
This part of ISO 7153 contains a survey and a selection of stainless steels available for use in the manufacture of surgical, dental and specific instruments for orthopaedic surgery.
| 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 |
| §878.4820 | Guide, Drill, Ligament | Class 1 | LXI |
| §888.3050 | Accessories, Fixation, Spinal Interlaminal | Class 2 | LYP |
| §888.4540 | Accessories, Fixation, Spinal Intervertebral Body | Class 1 | LYQ |
| §888.4540 | Bone Mill | Class 1 | LYS |
| There is no relevant guidance developed at this time. |