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This practice covered two procedures for conditioning non-absorbable polymer matrix composite (PMC) materials and implant devices in a liquid environment to obtain a state of saturation.
Formerly under the jurisdiction of Committee F04 on Medical and Surgical Materials and Devices, this practice was withdrawn in June 2017. This standard is being withdrawn without replacement due to its limited use by industry.
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 , may be followed.
1.3 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.
1.4 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.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
D618 Practice for Conditioning Plastics for Testing
D756 Practice for Determination of Weight and Shape Changes of Plastics Under Accelerated Service Conditions
D3878 Terminology for Composite Materials
D5229/D5229M Test Method for Moisture Absorption Properties and Equilibrium Conditioning of Polymer Matrix Composite Materials
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ASTM F1634-95(2016), Standard Practice for