Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
041
|
Date of Entry 04/04/2016
|
FR Recognition Number
|
8-399
|
Standard | |
ASTM F90-14 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605) |
|
Scope/Abstract1.1 This specification covers the requirements for wrought cobalt-20chromium-15tungsten-10nickel alloy used for surgical implants. The properties specified apply specifically to wrought bar, rod, wire, sheet, and strip, but do not apply to surgical fixation wire (see Specification F1091). |
|
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.
|
|
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. |