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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 11-83
Standard
ISO 13402 First edition 1995-08-01
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
Scope/Abstract
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).

Extent of Recognition
Complete standard
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
§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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Mark N. Melkerson
  FDA/OMPT/CDRH/ODE/DOD/
  301-796-6383
  mark.melkerson@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Orthopedic
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