| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
061
|
Date of Entry 12/18/2023
|
|
FR Recognition Number
|
4-320
|
| Standard | |
ISO 13402 First edition 1995-08-01
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
|
Scope/AbstractThis 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). |
|
| Extent of Recognition
|
Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §878.4820 |
Guide, Drill, Ligament
|
Class 1
|
LXI
|
| §888.3050 |
Accessories, Fixation, Spinal Interlaminal
|
Class 2
|
LYP
|
| §888.4300 |
Gauge, Depth
|
Class 1
|
HTJ
|
| §888.4540 |
Scissors, Orthopedic, Surgical
|
Class 1
|
HRR
|
| §888.4540 |
Stripper, Surgical
|
Class 1
|
HRT
|
| §888.4540 |
Reamer
|
Class 1
|
HTO
|
| §888.4540 |
File
|
Class 1
|
HTP
|
| §888.4540 |
Broach
|
Class 1
|
HTQ
|
| §888.4540 |
Knife, Orthopedic
|
Class 1
|
HTS
|
| §888.4540 |
Burr, Orthopedic
|
Class 1
|
HTT
|
| §888.4540 |
Bit, Drill
|
Class 1
|
HTW
|
| §888.4540 |
Rongeur
|
Class 1
|
HTX
|
| §888.4540 |
Impactor
|
Class 1
|
HWA
|
| §888.4540 |
Extractor
|
Class 1
|
HWB
|
| §888.4540 |
Starter, Bone Screw
|
Class 1
|
HWD
|
| §888.4540 |
Corkscrew
|
Class 1
|
HWI
|
| §888.4540 |
Awl
|
Class 1
|
HWJ
|
| §888.4540 |
Trephine
|
Class 1
|
HWK
|
| §888.4540 |
Set, Hollow Mill
|
Class 1
|
HWL
|
| §888.4540 |
Instrument, Compression
|
Class 1
|
HWN
|
| §888.4540 |
Skid, Bone
|
Class 1
|
HWO
|
| §888.4540 |
Punch, Femoral Neck
|
Class 1
|
HWP
|
| §888.4540 |
Passer
|
Class 1
|
HWQ
|
| §888.4540 |
Driver, Prosthesis
|
Class 1
|
HWR
|
| §888.4540 |
Countersink
|
Class 1
|
HWW
|
| §888.4540 |
Tap, Bone
|
Class 1
|
HWX
|
| §888.4540 |
Probe
|
Class 1
|
HXB
|
| §888.4540 |
Wrench
|
Class 1
|
HXC
|
| §888.4540 |
Tamp
|
Class 1
|
HXG
|
| §888.4540 |
Passer, Wire, Orthopedic
|
Class 1
|
HXI
|
| §888.4540 |
Staple Driver
|
Class 1
|
HXJ
|
| §888.4540 |
Holder, Needle; Orthopedic
|
Class 1
|
HXK
|
| §888.4540 |
Applier, Cerclage
|
Class 1
|
HXN
|
| §888.4540 |
Pusher, Socket
|
Class 1
|
HXO
|
| §888.4540 |
Instrument, Bending Or Contouring
|
Class 1
|
HXP
|
| §888.4540 |
Crimper, Pin
|
Class 1
|
HXQ
|
| §888.4540 |
Twister, Wire
|
Class 1
|
HXS
|
| §888.4540 |
Bender
|
Class 1
|
HXW
|
| §888.4540 |
Screwdriver
|
Class 1
|
HXX
|
| §888.4540 |
Brace, Drill
|
Class 1
|
HXY
|
| §888.4540 |
Cutter, Wire
|
Class 1
|
HXZ
|
| §888.4540 |
Positioner, Socket
|
Class 1
|
KIL
|
| §888.4540 |
Orthopedic Manual Surgical Instrument
|
Class 1
|
LXH
|
| §888.4540 |
Accessories, Fixation, Spinal Intervertebral Body
|
Class 1
|
LYQ
|
| §888.4540 |
Bone Mill
|
Class 1
|
LYS
|
| §888.4800 |
Template
|
Class 1
|
HWT
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Groups (STG)
| Dental/ENT (primary) |
| Orthopedic |
|
| *These are provided as examples and others may be applicable. |
|
|
