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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 11-83: ISO 13402 First edition 1995-08-01, surgical and dental hand instruments -- determination of resistance against autoclaving, corrosion and thermal exposure. (Orthopaedics)

Date of Standard: 1995. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Metallic Surgical Instruments
Processes Affected:
510(K) AND MDR Review, Design Controls
Type of Standard:
 Test Methods, International, Horizontal
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Accessories, Fixation, Spinal Intervertebral Body   LYQ
Unclassified Guide, Drill, Ligament   LXI
§888.3050 Accessories, Fixation, Spinal Interlaminal Class 2 LYP
§888.4540 Bone Mill Class 1 LYS
§888.4300 Gauge, Depth Class 1 HTJ
§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
§888.4800 Template Class 1 HWT
FDA Technical Contact:
 Mark N. Melkerson
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1410
  Silver Spring MD 20993
  301/796-6383
  email: mark.melkerson@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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