Plastics in medical technology: Key considerations
In medical technology, the plastic materials used are subject to extremely high standards. These relate to both biocompatibility and resistance to various sterilisation methods. We’ll go through some key factors.
What is Biocompatibility?
Biocompatibility means that a material must not cause harmful reactions in the body. It must not induce inflammation, allergies or damage to tissues. There are several standards, such as ISO 10993, which are used to assess this. So how do we ensure that our plastics meet these requirements?
To ensure biocompatibility, it is important that the material is pure and free from harmful substances. Furthermore, it must be thoroughly tested to verify that it meets all relevant requirements.
Sterilization of Plastic Materials
Another important aspect is sterilisation. The materials must be able to withstand sterilisation without their properties being compromised. Common methods include autoclaving, ethylene oxide (EtO) and gamma irradiation. Certain materials are better suited to certain methods.
Polyetheretherketone, abbreviated to PEEK, is a material frequently used in implants. It is biocompatible and withstands sterilisation using all these methods.
Common Plastic Materials in Medical Technology
Several plastic materials are frequently used in medical technology. Polycarbonate, abbreviated to PC, is often used for housings and other components due to its low weight, strength and suitability for sterilisation with EtO. Polytetrafluoroethylene, abbreviated to PTFE, is used in catheters and implants due to its biocompatibility and low friction.
Ultra-high molecular weight polyethylene, or PE-1000, is a common choice for joint implants. It is highly wear-resistant and can withstand the high loads to which joints are subjected.
- PEEK for implants
- PC for housings and components
- PTFE for catheters and implants
- PE-1000 for joint implants
Regulatory framework
The regulatory framework for plastic materials in medical technology is extensive and encompasses several standards and directives. It is important to have a good understanding of these regulations to ensure that the materials meet all requirements.
We offer a wide range of materials suitable for medical device applications, including PEEK, PC, PTFE and PE-1000. Our materials are tested for biocompatibility and can be sterilised using various methods.
Do you have any questions about plastic materials for medical devices? Please feel free to contact us; we’ll help you find the right material for your needs.
Plastmaterial i medicinteknik: Viktiga aspekter