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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 11-226
Standard
ASTM F1089-10
Standard Test Method for Corrosion of Surgical Instruments
Scope/Abstract
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of surgical instruments intended for reuse in surgery and fabricated from stainless steel such as, but not limited to, those listed in Specification F899.

1.2 Austenitic (Class 3), martensitic (Class 4), precipitation hardenable (Class 5), and ferritic (Class 6) materials shall use the boil test.

1.3 Ferritic (Class 6) materials with a minimum 16 % chromium content, austenitic (Class 3), and precipitation hardenable (Class 5) materials shall use the boil test and the copper sulfate test.

1.4 The copper sulfate test is used to detect the presence of metallic iron and iron oxide on the surface of materials.

1.5 The copper sulfate test is not recommended for martensitic materials. (See Note X1.1.)

1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardenable materials to detect free iron or any other anodic surface contaminants on stainless steel.

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.
Transition Period
FDA recognition of ASTM F1089-10 [Rec# 11-226] will be superseded by recognition of ASTM F1089-18 [Rec# 8-478]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-226] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 11-226] will not be accepted.
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
§888.3050 Accessories, Fixation, Spinal Interlaminal Class 2 LYP
§878.4820 Guide, Drill, Ligament Class 1 LXI
§888.4540 Accessories, Fixation, Spinal Intervertebral Body Class 1 LYQ
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Terry O. Woods
  FDA/OMPT/CDRH/OSEL/DAM/
  301-796-2503
  terry.woods@fda.hhs.gov
 David M. Saylor
  FDA/OMPT/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Orthopedic
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