| ISO 13402 First edition 1995-08-01 Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 11-83 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Orthopedic |
| FDA Tech | Mark N. Melkerson FDA/OMPT/CDRH/ODE/DOD/ 301-796-6383 mark.melkerson@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.
This International Standard describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.
The requirements for such tests are defined and stated in the product standard along with the number of cycles for each test procedure.
Other, additional, tests may also be required (see the Introduction).
| 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. |