This week, the team has focused on design standards to follow. Standards, developed by experts in their field, are rules, testing methods, definitions, recommended practices, or specifications that promote uniformity. Below are the standards that will be referenced in the design and testing of this project. Subject to change.
| Standard | Name | Justification |
| ASTM F1635-16 | Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated forms of Surgical Implants | This standard will be referenced in the consideration of different materials that could be used as the material for the valve, if a biodegradable material is the option chosen. |
| UNE – EN 13868-2002 | Test Methods for Kinking of SIngle Lumen Catheters and Medical Tubing | This standard will be referenced in the testing of the polymer and how the effects of different pH values change it’s properties due to degradation. |
| D3826-18 | Standard Practice for Determining Degradation End Point in Degradable Polyethylene and Polypropylene Using a Tensile Test |
This standard will be referenced in both the catheter and valve design. The standards for leakage and surface properties will be utilized, in addition to the testing parameters for leakage, pressure under standard conditions, and the determination of flow rate through the valve. Though the catheter will be a short-term implantation into the body, the valve should follow the constraints of a normal catheter for long-term placement in the body. |
| ISO 10555-1ASTM F2004-05 | Intravascular Catheters Sterile and Single-Use Catheters | These standards will be referenced in designing the valve. The material that will be used to design the device has not been chosen but there is a possibility of using an alloy. These two standards provide procedures that determine the transformation temperatures of nickel-titanium shape memory alloys. |
| ASTM F2082-06 | Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
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| ASTM G71-81 | Standard Guide for Conducting and Evaluating Galvanic Corrosion Tests in Electrolytes |
This standard will be referenced in the valve design. Since a material has not been picked yet, it is possible that a metal or a polymer and a metal combination will be used, making this standard necessary for testing. This standard covers corrosion tests when in contact with electrolytes under low flow conditions, and will likely have to be modified to be used for the valve design. |
| FDA Code of Federal Regulations Part 876.513 | Urological catheter and accessories | This code will be referenced with respect to the catheter, as this code discusses catheters used in the urethra. It also discusses how the catheter is classified, based on some requirements. |