YYT0342-2002外科植入物接骨板弯曲强度和刚度的测定.pdf

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1、ICS11.040.40C30YY中华人民共和国医药行业标准YY/'r0342-2002外科植入物接骨板弯曲强度和刚度的测定Implantsforsurgery-Determinationofbendingstrengthandstiffnessofboneplates(ISO9585:1990,IDT)2002一09一24发布2003一04一01实施国家药品监督管理局发布YY/T0342-2002目次前言·······················································

2、········································。····················，⋯1范围····。。······。···。······························································································⋯⋯12术语及定义·········································。···············，················

3、····························⋯⋯13仪器设备·..............................................................................................................24试验步骤········································。。······························································⋯⋯2

4、5结果计算·······································································································⋯⋯46检验报告·········································································································⋯⋯4YY/T0342一2002oli胃本标准等同采用国际标准ISO9585:

5、1990(外科植人物—接骨板弯曲强度和刚度的测定)(英文版)。在技术内容上与国际标准完全等同。本标准由国家药品监督管理局提出并批准。本标准由全国外科植人物和矫形器械标准化技术委员会(CSBTS/TC110)归门。本标准起草单位:国家药品监督管理局天津医疗器械质量监督检验中心。本标准主要起草人:宋铎、任凤妹、张文惠。YY/T0342-2002外科植入物接骨板弯曲强度和刚度的测定范围本标准规定了直型接骨板弯曲强度和刚度的测定方法。包括术语及定义、仪器设备、试验步骤、结果计算、检验报告。本标准适用于直型接骨板、有一定角度

6、接骨板的直板部分以及为了在安装时对骨产生预载而有小的初始弯曲的接骨板。本标准不适用于长度小于50mm的接骨板，也不适用于设计成和髓内装置一起使用或成为髓内装置一部分的接骨板。”2术语及定义本标准采用下列定义。2.1力矩moment力矩是一个力绕一个轴的转动效果，数学表达式为力F与从轴到力的作用线的垂直距离h的乘积。单位:N·mo2.2弯矩Msbendingmoment力矩沿着垂直于物体长轴的轴上作用并且通常产生侧向位移，则称为弯矩。单位:N·m,2.3挠度deflection由于弯曲而产生的垂直于接骨板初始轴线的线

7、性距离称为挠度。单位:m2.4弯曲强度bendingstrength在断裂点或某一规定屈服点的弯矩值中，取其较小的作为弯曲强度。单位:N·m.2.5等效弯曲刚度equivalentbendingstiffness根据试件的外形尺寸和由力学测试法确定的载荷—挠度曲线图线性部分斜率S计算出的接骨板刚度称为等效弯曲刚度。“，单位:N·ni,o1)对长度小于50mm接骨板的测定方法在起草之中2)这个等效弯曲刚度考虑了接骨板的孔和沟槽YY/T0342-2002仪器设备I1测试装置依据图I所示构造一个加载系统，其中的四个辊轴(

8、用带阴影线的圆表示)必须固定，且其轴线保持平行。3-2辊轴辊轴为等直径圆柱状，直径在8mm-13mm范围内，或者具有与被测接骨板横截面相适应的外形，并且平均直径在8mm-13mm范围内。要求其中一个辊轴用以固定试样.以限制其纵向移动，并要求所有的辊轴应保持它们的相对位置。33加载方法可以用一个材料试验机施加载荷。3.4量具用于测量相对位移的装置。4试验步骤4