Standard Practice for In-Vitro Environmental Conditioning of Polymer Matrix Composite Materials and Implant Devices
|Publication Date:||10 November 1995|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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.
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 D5229/D5229M, may be followed.
Diffusion of liquid into a solid material is a slow process. While the time necessary to achieve saturation at 37°C may be sufficiently short for thin specimens, such as fracture fixation plates, it may be prohibitively long in thick sections, such as femoral components for hip arthroplasty. However, the diffusion process may be accelerated at an elevated temperature. Consequently, two separate procedures (Procedures A and B) are presented in this practice. Procedure A covers exposing the specimen to the desired conditioning environment at 37°C. Procedure B prescribes a method to accelerate the diffusion process by conditioning the specimen at a selected elevated temperature.
This practice does not specify the test environment to be used for conditioning. However, the pH value of immersion liquid shall be maintained at 7.4 ± 0.2 to simulate the in vivo environment.
The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
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 and health practices and determine the applicability of regulatory limitations prior to use.