The proposed design for our back support device prototype will prioritize both functional and safety considerations, adhering strictly to biocompatibility standards as per ISO 10993-1. This will ensure that the device is safe for either brief or prolonged contact with the human body. Below is an overview of the planned design and how each component will comply with the necessary standards.
Materials and Construction
Nylon Mesh Vest:
The vest will be crafted from biocompatible nylon mesh material to provide breathability and comfort. It will be structured to accommodate inserts for spine support and gel cushioning, ensuring ergonomic alignment and sustained comfort for the user.
Semi-Rigid Spine Support:
The spine support will be 3D printed using Polyurethane Foam Plastic filament, a material selected for its durability, flexibility, and suitability for safe contact with skin. Its semi-rigid structure will aim to optimize spinal alignment by balancing support and comfort.
Gel Cushioning Insert:
A gel cushioning insert, precision-cut from a pre-manufactured gel sheet, will be positioned within the vest. This cushioning is intended to add a layer of comfort by reducing pressure and evenly distributing weight. Thorough Extraction Studies (ISO 10993-12) will be conducted to evaluate leachable substances, ensuring their safety for skin contact.
Adjustable Velcro Straps:
Velcro straps will be sewn onto the vest to allow adjustable fitting. The materials used in these straps will undergo Sensitization (ISO 10993-10) and Irritation Testing (ISO 10993-10) to confirm that no allergic or irritant reactions occur with skin contact.
Biocompatibility Testing and Compliance
Risk Assessment and Material Composition:
All materials will be rigorously characterized to ensure compliance with ISO 10993-1. Risk assessments will focus on identifying potential biocompatibility concerns, particularly regarding prolonged skin contact. The chemical composition of each material will be evaluated to confirm that all components are safe for their intended use.
Cytotoxicity Testing (ISO 10993-5):
The device’s materials will undergo cytotoxicity testing to evaluate cellular responses. Direct contact testing with cultured cells will ensure that no harmful effects arise from skin or tissue contact.
Extraction Studies:
The gel insert and other materials will be subjected to Extraction Studies (ISO 10993-12) to identify any potentially harmful leachable substances. These studies will confirm that no dangerous substances will migrate from the device into the body.
Final Assembly
The device’s components will be securely assembled, with the gel cushioning and spine support positioned within the nylon mesh vest to maximize stability and comfort. Velcro straps will enable users to customize the fit, ensuring both functionality and a user-centered design.
This future-tense revision outlines plans for the device's development while emphasizing the steps yet to be completed.