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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 8-478
ASTM  F1089-18
Standard Test Method for Corrosion of Surgical Instruments
1.1 This test method covers general test procedures and evaluation criteria for the corrosion resistance of new and reusable surgical instruments fabricated from stainless steel alloys, such as, but not limited to, those listed in Specification F899.
1.2 Instruments containing stainless steel materials that are exclusive to the following shall use the boil test and the copper sulfate test: austenitic materials (Class 3), precipitation hardening materials (Class 5), and ferritic materials (Class 6) containing equal or greater than 16 % chromium.
1.3 Instruments containing any of the following stainless steel materials shall use the boil test: martensitic materials (Class 4) and ferritic materials (Class 6) containing less than 16 % chromium.
1.4 The copper sulfate test is used to detect the presence of free iron on the surface of materials.
1.5 The copper sulfate test as described in 6.2 is not recommended for martensitic materials or for ferritic materials containing less than 16% chromium because these steels may give a positive indication irrespective of the presence or absence of anodic surface contaminants (see X1.5).
1.6 The boil test is applicable to martensitic, austenitic, ferritic, and precipitation hardening materials to detect surface imperfections, free iron, or 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.
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
§888.4800 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 Contacts
 Terry O. Woods
 David M. Saylor
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.