What is BS EN ISO 10555-5:2018?

BS EN ISO 10555-5:2018 is an international standard that provides guidelines and requirements for the design, testing, and labeling of intravascular catheters. This standard focuses specifically on catheters made of polyurethane, including those used in peripheral veins and subcutaneous infusion.

The Importance of BS EN ISO 10555-5:2018

Adhering to BS EN ISO 10555-5:2018 is crucial for manufacturers and medical professionals involved in the production and usage of intravascular catheters. The standard aims to ensure the safety and performance of these medical devices, reducing the risks associated with their use.

This standard provides detailed specifications for various aspects of intravascular catheters, such as the material composition, dimensions, and mechanical properties. It also covers requirements for sterility, biocompatibility, and labeling instructions. By following these guidelines, manufacturers can produce high-quality catheters that meet international standards, ultimately benefiting patients and healthcare providers alike.

Key Requirements of BS EN ISO 10555-5:2018

One of the key requirements outlined in BS EN ISO 10555-5:2018 is compliance with the dimensional specifications. This ensures that catheters have precise outer diameters, lengths, and wall thicknesses, allowing for accurate placement and optimal flow rates.

The standard also emphasizes the importance of biocompatibility, requiring catheters to undergo biocompatibility testing to assess the potential risks of toxicity, irritation, and sensitization. Additionally, it provides guidelines on the selection and evaluation of materials, including recommendations for minimizing the risk of adverse reactions.

BS EN ISO 10555-5:2018 further addresses aspects such as kink resistance, tensile strength, and suture retention strength. These mechanical properties are essential to ensure the stability and durability of catheters during use.

Conclusion

BS EN ISO 10555-5:2018 plays a crucial role in ensuring the safety, performance, and reliability of intravascular catheters made of polyurethane. By adhering to this standard, manufacturers can produce high-quality catheters that meet international requirements, reducing the risks associated with their usage.

Medical professionals rely on these guidelines to select and use catheters that provide optimal patient care. Ultimately, the strict adherence to BS EN ISO 10555-5:2018 benefits all stakeholders involved in the design, production, and usage of intravascular catheters by promoting patient safety and improving medical outcomes.