Injection molding of medical devices: How to select materials conforming to ISO 13485?
Driven by the trends of intelligence and miniaturization in medical devices, plastic injection-molded parts have deeply integrated into various aspects of medical devices, becoming a key element to ensure the functionality and performance of medical devices. Selecting materials that conform to the ISO 13485 standard serves as the cornerstone for ensuring the safety, compliance, and reliability of medical devices.
I. ISO 13485 Standard: The "Golden Yardstick" for the Quality of Medical Devices
As an internationally recognized quality management system standard for medical devices, ISO 13485 puts forward stringent requirements for injection molding materials. Materials that meet this standard must not only possess excellent biocompatibility and sterilization stability but also ensure batch consistency and traceability throughout the entire product life cycle, safeguarding the quality and safety of medical products in all aspects.
II. Core Traits of ISO 13485 Compliant Materials
1. Biocompatibility Achievement: Strictly adhere to authoritative test standards such as USP Class VI and ISO 10993 to ensure the safety of materials when in contact with the human body.
2. Strong Sterilization Compatibility: Be capable of withstanding various sterilization methods, including ethylene oxide (EO), gamma rays, and high-temperature steam, to meet the production requirements of different medical devices.
3. Low Extractables and Volatiles: Minimize the potential risks of materials to the medical environment and the human body.
4. Complete Medical Grade Certification: Material manufacturers are required to provide detailed certification documents and change control plans to ensure the full controllability of quality.
III. "Star Materials" in the Field of Medical Injection Molding
1. PC (Polycarbonate): With high transparency and excellent toughness, it is commonly used in precision components such as IV components and connectors.
2. PP (Polypropylene): It has significant cost-performance advantages and is widely applied to consumables such as disposable syringes and sampling tubes.
3. TPE/TPU (Thermoplastic Elastomers): Thanks to its soft touch and good elasticity, it becomes the preferred choice for sealing rings and soft connection components.
4. PEEK: It has high strength and high-temperature resistance, making it an ideal material for implantable medical devices.
IV. Professional Escort by TXS: Full-link Compliance from Material Selection to Production
TXS has a deep presence in the field of medical device injection molding. It not only provides one-stop services ranging from structural design, mold development to injection molding production and clean assembly but also intervenes from the source of raw materials. Through technical audits and verification, it ensures that materials fully meet the ISO 13485 standard in terms of structural adaptability, sterilization tolerance, and usage scenario requirements.
Core Advantages of TXS
✅ A hundred-thousand-class clean injection molding workshop and a ten-thousand-class laboratory to strictly control the production environment;
✅ Specialize in the development of medical-grade injection molding molds and the mass manufacturing of components;
✅ A professional team to assist with material verification and mold flow analysis, avoiding potential risks;
✅ All processes comply with the ISO 13485 standard to safeguard product quality.
On the path of compliant production of medical devices, every step is related to life and health. Choose TXS and let professionalism build a defense line for the quality of your products!
#Medical Device Injection Molding #ISO13485 #Biocompatibility #Medical Material Selection
Hot News
