ASTM F1672-95(2000) - 1.1.2000
 
1. Scope

1.1 This specification covers patellar resurfacing devices used to provide a functioning articulation between the bones of the patella and the femur.

1.2 This specification is intended to provide basic descriptions of material and device geometry. Additionally, those characteristics determined to be important to in-vivo performance of the device are defined.

1.3 This specification does not cover the details for quality assurance, design control, and production control contained in 21 CFR 820 and ISO 9001.

Note 1--Devices for custom applications are not covered by this specification.

 
2. Referenced Documents

F799-19

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

F648-21

Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

F563-00

Standard Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy for Surgical Implant Applications (UNS R30563) (Withdrawn 2005)

F562-22

Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)

F451-21

Standard Specification for Acrylic Bone Cement

F138-19

Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

F75-23

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)

F136-13(2021)e1

Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) (Includes all amendments and changes 8/19/2021).

F90-23

Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

F86-21

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

F1147-05(2017)e1

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).

F1044-05(2017)e1

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).

F983-86(2018)

Standard Practice for Permanent Marking of Orthopaedic Implant Components

F603-12(2020)

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

ISO 9001

Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.

F1160-14(2017)e1

Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings (Includes all amendments and changes 1/19/2018).

F1108-21

Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F746-04(2021)

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

F745-07

Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications (Withdrawn 2012)

F732-17

Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses