- 期刊
PMMA骨水泥力學分析方法之建立
The Study in PMMA Bone Cement Mechanical Analysis
摘要
配合行政院衛生署於101年1月5日公告「PMMA骨水泥臨床前測試基準」進行PMMA骨水泥力學分析方法及檢驗能量之建立。本研究於101年4至11月間，自醫療器材經銷商抽購檢體共計5件（每件8-10包，皆同批號）其中美國製2件，德國製2件，英國製1件。試驗設計參考國際標準ISO 5833及ASTM F451，建立抗壓強度、抗彎強度及抗彎模量測試之方法，並進一步探討各試驗參數對材料試驗結果之影響。在抗壓試驗中比較不同壓縮速率（19.8、22.7及25.6 mm/min）下抗壓強度的力學表現。而在抗彎試驗中探討使用撓度計與移動橫桿（cross head）移動距離所計算出的抗彎模量之差異性。結果：5件市售檢體平均抗壓強度在不同壓縮速率下皆大於70 MPa，平均抗彎強度皆大於50 MPa，平均抗彎模量皆大於1800 MPa。利用移動橫桿所得抗彎模量會高於使用撓度計之抗彎模量，經迴歸分析求得迴歸判定係數（r^2）為0.992。
並列摘要
In order to meet ＂Guidance for Pre-clinical Testing of Poly (methyl methacrylate) (PMMA) Bone Cement.＂ announced by Taiwan Food and Drug Administration (TFDA) on January 5, 2012, the procedures of mechanical analysis for PMMA bone cement were established. Five samples of PMMA bone cement were collected from medical device dealers from April to November in 2012, 2 made in USA, 2 from Germany, and 1 from UK. We followed the international standard ISO 5833 and ASTM F451 to establish the compressive strength test, bending strength test and bending modulus test. Furthermore, the impact of various experimental parameters on the material test was compared. In the compressive strength test, the compressive strength was analyzed using different compressive velocity (19.8, 22.7 and 25.6 mm/min).The displacement gage and cross head distance were used to measure the bending strength and modulus respectively. The results revealed that average compressive strength of different velocity were greater than 70 MPa and the average bending strength were greater than 50 MPa and the average bending modulus were greater than 1800 MPa. The bending modulus calculated using the cross head distance was higher than that using displacement gage. The coefficient of determination was calculated by the linear regression equation with the regression coefficient (r^2) of 0.992.