ASTM F2381-19
Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
| Označení normy: | ASTM F2381-19 |
| Vydáno: | 01.10.2019 |
| Status: | Active |
| Počet stran: | 5 |
| Sekce: | 13.01 |
| Označení: | crosslinking; FTIR (Fourier Transform Infrared); implant; trans-vinylene index; TVI; UHMWPE (ultra-high molecular weight polyethylene); |
| ASTM označení: | ASTM F2381 |
| Nahrazuje: | F2381-10 |
1.1 This test method describes the measurement of the number of trans-vinylene groups in ultra-high molecular weight polyethylene (UHMWPE) intended for use in medical implants. The material is analyzed by infrared spectroscopy.
1.2 This test method is based on Guide F2102.
1.3 The applicability of the infrared method has been demonstrated in other literature reports. This particular method, using the intensity (area) of the C-H absorption centered at 1370 cm-1 to normalize for the sample’s thickness, will be validated by an Interlaboratory Study (ILS) conducted according to Practice E691.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.