聚合物基体复合材料和植入装置的实验室条件下环境调节标准实施规程

标准编号：ASTM F1634-1995(2000)

提出单位：F04.15

起草单位：F04.15

发布日期：1995年

实施日期：10000000

主      题：加速老化 复合物 纤维 环境调节 状态调节 外科设备 医疗的 外科植入物 高聚物 在实验室条件下 加速调节 实验室环境 聚合物基体复合材料 水分分析法 整形外科医疗设备 使用 试验 实施规程 植入设备 

中国标准分类号：C35

国际标准分类号：11_040_40

摘      要：The conditioning procedures covered in this practice provide methods for saturating PMC specimens in a liquid environment prior to conducting other tests for property evaluation. The conditioning may affect geometric and dimensional changes in specimens. In some severe cases, chemical changes may occur in the fiber, polymer and fiber-polymer interphase and interface. Caution must be taken if Procedure B (10.2, Procedure Bx2014;Accelerated Moisture Saturation at Elevated Temperature) is followed to condition PMC specimens at an elevated temperature. Physical and chemical reactions in materials are normally temperature dependent. An increase in experimental temperature may accelerate a desirable moisture diffusion process. However, elevated temperatures above 37x00B0;C may also cause undesirable reactions that do not represent appropriate responses of materials at 37x00B0;C. Consequently, a pilot study is recommended in Procedure B to determine if a selected elevated temperature can be used for accelerated conditioning. If the properties of materials are determined to be irreversibly affected by this pilot study at the selected elevated temperature, then either an appropriate lower elevated temperature should be determined by repeating the pilot study, or Procedure B should not be used.1.1 This practice covers two procedures for conditioning non-absorbable polymer matrix composite (PMC) materials and implant devices in a liquid environment to obtain a state of saturation. 1.2 The purpose of this practice is to standardize methods and reporting procedures for conditioning PMC materials and implant devices (PMC specimens) in a user selected liquid environment prior to conducting subsequent tests. It is not the purpose of this practice to determine the diffusion coefficients or actual saturation levels of a given liquid into the materials and devices. For these determinations, other procedures, such as Test Method D 5229, may be followed. 1.3 Diffusion of liquid into a s