Pascaud R S, Evans W T, McCullagh P J, FitzPatrick D
Department of Mechanical and Manufacturing Engineering, University of Glamorgan, South Wales, United Kingdom.
J Biomed Mater Res. 1996 Dec;32(4):619-26. doi: 10.1002/(SICI)1097-4636(199612)32:4<619::AID-JBM15>3.0.CO;2-8.
The thermal and structural analysis of a total 22 batches from three medical grade ultrahigh molecular weight polyethylene (UHMW-PE) resins was determined using the DSC method. Batch to batch variations of approximately 5% were obtained for the melting temperature and the degree of crystallinity. The variations correlated both to the changes caused by gamma-irradiation sterilization and subsequent aging, and to the differences in DSC results obtained from various laboratories on materials believed to exhibit essentially similar clinical performances. Varying the sample weight from 4.4 to 27.1 mg resulted in a significant relative increase of 5% in the degree of crystallinity. The study shows that the standard double melting/recrystallisation procedure for DSC evaluation produces variations in the melting behaviors of approximately the same magnitude as those indicated by batch lot or sterilization/aging.
采用差示扫描量热法（DSC）对三种医用级超高分子量聚乙烯（UHMW-PE）树脂的总共22批次产品进行了热分析和结构分析。测得的熔点温度和结晶度的批次间差异约为5%。这些差异既与γ射线辐照灭菌及随后老化所引起的变化有关，也与不同实验室对认为临床性能基本相似的材料所得到的DSC结果差异有关。将样品重量从4.4毫克改变至27.1毫克，导致结晶度相对显著增加了5%。该研究表明，用于DSC评估的标准双熔化/再结晶程序所产生的熔化行为变化幅度，与批次或灭菌/老化所表明的变化幅度大致相同。
