The Spring ASTM meeting of F04 (Biomedical Materials and Devices) met in Indianapolis, IN this week. Some key highlights of the meeting are as follows:
Cleanliness of Biomedical Devices
The standard for shipping of potentially infectious tissues and devices was approved, and is now available as ASTM F2995-13.
ASTM F561 (Device retrieval) will be amended to contain a new method for isolating polyethylene particles from tissue.
Two draft standards were discussed. The first, Validating Cleanlines for Biomedical Devices and Instruments, is making good progress, and should be ready for another sub-committee vote prior to the next meeting. The second, Test Soils, is awaiting more information on formulas from some committee members. Two additional draft standards (Designing devices for cleaning, and Establishing threshold limits for residue levels) are expected to be ready for discussion by the November meeting.
The committee on UHMWPE discussed several topics, including the need for 3 new standards:
1. Electron spin resonance spectroscopy of free radical content in UHMWPE.
2. Fatigue crack propagation analysis of UHMWPE
3. Oxidation induction time quantification of antioxidant concentration in UHMWPE
Cambridge Polymer Group is working on these three draft standards.
Additional discussion included a small punch round robin study on UHMWPE, which is expected to take place in the next few months. The PEEK standard was also discussed, with debate on the need for different classifications of PEEK, along with additional test methods for extractables and metals levels in PEEK.
A workshop on polymer additives is being considered for a meeting 1 year from now. Interested parties should contact Cambridge Polymer Group for more details.
CPG researchers suggested a modification to the existing benzoyl peroxide titration method in F451. A small round robin will take place in the next 6 months trying this new protocol.