Search ASTM
C14 GLASS AND GLASS PRODUCTS C21 CERAMIC WHITEWARES AND RELATED PRODUCTS D01 PAINT AND RELATED COATINGS, MATERIALS, AND APPLICATIONS D06 PAPER AND PAPER PRODUCTS D09 ELECTRICAL AND ELECTRONIC INSULATING MATERIALS D10 PACKAGING D11 RUBBER D12 SOAPS AND OTHER DETERGENTS D13 TEXTILES D14 ADHESIVES D15 ENGINE COOLANTS AND RELATED FLUIDS D20 PLASTICS D21 POLISHES D31 LEATHER E12 COLOR AND APPEARANCE E18 SENSORY EVALUATION E20 TEMPERATURE MEASUREMENT E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E41 LABORATORY APPARATUS E53 ASSET MANAGEMENT E57 3D IMAGING SYSTEMS F02 FLEXIBLE BARRIER PACKAGING F05 BUSINESS IMAGING PRODUCTS F06 RESILIENT FLOOR COVERINGS F08 SPORTS EQUIPMENT, PLAYING SURFACES, AND FACILITIES F09 TIRES F10 LIVESTOCK, MEAT, AND POULTRY EVALUATION SYSTEMS F11 VACUUM CLEANERS F13 PEDESTRIAN/WALKWAY SAFETY AND FOOTWEAR F14 FENCES F15 CONSUMER PRODUCTS F16 FASTENERS F24 AMUSEMENT RIDES AND DEVICES F26 FOOD SERVICE EQUIPMENT F27 SNOW SKIING F37 LIGHT SPORT AIRCRAFT F43 LANGUAGE SERVICES AND PRODUCTS F44 GENERAL AVIATION AIRCRAFT D21 POLISHES D26 HALOGENATED ORGANIC SOLVENTS AND FIRE EXTINGUISHING AGENTS D33 PROTECTIVE COATING AND LINING WORK FOR POWER GENERATION FACILITIES E05 FIRE STANDARDS E27 HAZARD POTENTIAL OF CHEMICALS E30 FORENSIC SCIENCES E34 OCCUPATIONAL HEALTH AND SAFETY E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E52 FORENSIC PSYCHOPHYSIOLOGY E54 HOMELAND SECURITY APPLICATIONS E58 FORENSIC ENGINEERING F06 RESILIENT FLOOR COVERINGS F08 SPORTS EQUIPMENT, PLAYING SURFACES, AND FACILITIES F10 LIVESTOCK, MEAT, AND POULTRY EVALUATION SYSTEMS F12 SECURITY SYSTEMS AND EQUIPMENT F13 PEDESTRIAN/WALKWAY SAFETY AND FOOTWEAR F15 CONSUMER PRODUCTS F18 ELECTRICAL PROTECTIVE EQUIPMENT FOR WORKERS F23 PERSONAL PROTECTIVE CLOTHING AND EQUIPMENT F26 FOOD SERVICE EQUIPMENT F32 SEARCH AND RESCUE F33 DETENTION AND CORRECTIONAL FACILITIES G04 COMPATIBILITY AND SENSITIVITY OF MATERIALS IN OXYGEN ENRICHED ATMOSPHERES D10 PACKAGING D11 RUBBER E31 HEALTHCARE INFORMATICS E35 PESTICIDES, ANTIMICROBIALS, AND ALTERNATIVE CONTROL AGENTS E54 HOMELAND SECURITY APPLICATIONS E55 MANUFACTURE OF PHARMACEUTICAL PRODUCTS E56 NANOTECHNOLOGY F02 FLEXIBLE BARRIER PACKAGING F04 MEDICAL AND SURGICAL MATERIALS AND DEVICES F29 ANESTHETIC AND RESPIRATORY EQUIPMENT F30 EMERGENCY MEDICAL SERVICES G04 COMPATIBILITY AND SENSITIVITY OF MATERIALS IN OXYGEN ENRICHED ATMOSPHERES
Bookmark and Share

UpDate

UpDate

Surgical Implant Polymers

Raw materials used for polyetherketoneketone polymer surgical implants.

Many types of surgical implants and other medical devices are made of polymeric materials. A new ASTM standard covers the raw material properties for a high strength polymer used for surgical implants.

F2820, Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications, has been developed by ASTM International Subcommittee F04.11 on Polymeric Materials, part of Committee F04 on Medical and Surgical Devices.

According to Jon Mosely, Ph.D., director of implant technology, Wright Medical Technology Inc., F2820 will facilitate regulatory approval for new devices. Material requirements set forth in the standard are based on the properties of resins that have been proven to be biocompatible and have been used in successful long-term implantable devices.

F2820 specifies allowable ranges for composition, mechanical attributes and physical properties as well as acceptable quality control practices for PEKK polymers used in the manufacture of medical devices. Each of the factors covered by the standard is important in assuring that the materials used will perform as expected.

“This is of particular importance in permanent implant applications, where failure can lead to additional surgical procedures and potentially harm the patient,” says Moseley, who is chairman of F04.11. “In addition, using materials that meet the requirements of F2820 can reduce or eliminate the need for animal testing for these materials.”

F2820 will be used by resin manufacturers for quality control and as a guide for developing master files, compilations of test data for use by device developers and regulatory agencies. The standard will be useful in the approval process for new devices because both developers and agencies recognize the value of using standardized materials to help ensure the safety and efficacy of medical devices.

Interested parties are welcome to participate in the standards developing activities of F04.11. In addition to the task group that developed F2820, other task groups are working on acrylics (for example, bone cement), absorbable polymers and ultra-high molecular weight polyethylene. The subcommittee is particularly interested in participation from surgeons as they are in the best position to provide feedback on the performance of devices fabricated from polymeric materials.

To purchase ASTM standards, visit www.astm.org and search by the standard designation, or contact ASTM Sales (phone: 877-909-ASTM; sales@astm.org).

CONTACT Technical Information: Jon P. Moseley, Ph.D., Wright Medical Technology Inc. • Arlington, Tenn. • Phone: 901-867-4414 | ASTM Staff: Pat Picariello • Phone: 610-832-9720 | Upcoming Meeting: May 21-24 • May Committee Week • Indianapolis, Ind.

This article appears in the issue of Standardization News.