ASTM F1635 In vitro Degradation Test of Manufactured Forms for Hydrolytically Degradable Polymer Resins and Surgical Implants

ASTM Tests

ASTM F1635 In vitro Degradation Test of Manufactured Forms for Hydrolytically Degradable Polymer Resins and Surgical Implants

The ASTM F1635 test covers the in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants. The polymers and copolymers covered by this method consist of l - lactide, d - lactide, d,l -lactide, glycolide, caprolactone and p -dioxanone.

ASTM F1635 In vitro Degradation Test of Manufactured Forms for Hydrolytically Degradable Polymer Resins and Surgical Implants

Hydrolytically degradable polymers (HDP) or absorbable polymers have greatly influenced modern medicine. Absorbable polymers are a class of polymers that degrade after their intended use. Degradable polymers have a wide range of applications in medicine. They are used in everything from sutures to implants to drug delivery.

Samples are placed in buffered saline solution at physiological temperatures and periodically removed and tested for various properties. Degradation rates can be greatly influenced by the precise composition, sample size, polymer molecular weight, and crystallinity.

No-load mechanical hydrolytic evaluation is usually done to obtain a basic profile of the polymer. Mechanical loading is considered if in vivo loading is to be encountered . The cyclic loading can be approximated by static loading at the maximum load in the loop if it changes the fault mode.

Devices exposed to flow conditions during use may have a different degradation rate than other devices. For devices such as catheters, flow conditions must be estimated and reproduced in vitro.

Sterilization of absorbable material can cause changes in mechanical and molar mass properties. This can affect baseline testing. For this reason, samples should be sterilized and packaged as in actual use. Unsterilized samples can be tested for comparative results.

Phosphate-buffered saline (PBS) should be used as the soaking solution and pH maintained at 7.4, unless documented to have a different pH in the specific instrument and use. Bovine serum can also be used as a solution. The pH should be tested at least once a week.

The PBS/HDP ratio will be as high as is practical. 100 to 1 explained. More than one sample can be stored in the same container as long as proper sample separation is ensured. At least three samples shall be tested in each time period. The tests will be mass loss, molar mass and mechanical testing.

For many HDP resins, inter-lot variations in molar mass and residual monomer can be significant. This can affect degradation rates. It is recommended to analyze the residual monomer of the fragments. Molar Mass will be evaluated by solution viscosity or size exclusion chromatography (SEC).

The weight loss should be measured with an accuracy of 0,1% of the total sample weight. Samples should be dried to a constant weight.

This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The characteristics of the load type, magnitude and frequency for a particular application are beyond the scope of this test method.

Values ​​stated in SI units should be accepted as standard. No other units of measurement are included in this standard.

This standard does not purport to address all, if any, safety concerns associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory restrictions prior to use.

Our organization also provides testing services to enterprises within the scope of In vitro Degradation Test of ASTM F1635 Hydrolytically Degradable Polymer Resins and Forms Produced for Surgical Implants within the framework of laboratory testing services. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.

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