| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
8-478
|
| Standard | |
ASTM F1089-18
Standard Test Method for Corrosion of Surgical Instruments |
|
Scope/Abstract1.1 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
|
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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