What is BS EN ISO 594-4:2021?

BS EN ISO 594-4:2021 is a standard that specifies the requirements for two types of connectors used in medical devices, specifically those intended for human blood and fluid exposure. These connectors are known as "conical fittings" and are designed to provide a reliable and safe connection between medical devices such as syringes, needles, catheters, and other fluid-transfer devices.

The Importance of BS EN ISO 594-4:2021

This standard plays a crucial role in ensuring patient safety and preventing potentially life-threatening incidents caused by misconnections. In healthcare settings, various medical devices may need to be connected to transfer fluids, medications, or blood products. If incompatible connectors are used or the connection is not secure, it can lead to leakage, contamination, or even the wrong substances being administered to patients.

BS EN ISO 594-4:2021 sets forth the dimensional and performance requirements for conical fittings. It ensures that these connectors are standardized across different manufacturers and compatible with each other, regardless of brand or origin. By adhering to this standard, healthcare providers can minimize the risk of misconnections, improve their workflows, and enhance patient care.

Key Features of BS EN ISO 594-4:2021

The standard defines specific design attributes and dimensions for conical fittings. Some key features include:

Conical shape: The connectors have a tapered shape, allowing for a secure and leak-free connection when assembled properly.

Luer-lock system: BS EN ISO 594-4:2021 requires the use of a luer-lock mechanism to ensure a tight connection and prevent accidental disconnections.

Color-coded rings: The standard recommends the use of color-coding to differentiate between various types of connectors, reducing the likelihood of errors during setup.

Connectivity with other standards: BS EN ISO 594-4:2021 ensures compatibility with other internationally recognized standards, promoting interoperability and enabling seamless integration of medical devices.

Compliance and Certification

Manufacturers of medical devices must comply with BS EN ISO 594-4:2021 to ensure their products meet the required safety standards. Compliance can be demonstrated through various certifications, such as the CE marking in Europe. Regulatory bodies and healthcare institutions also play a vital role in enforcing and verifying adherence to this standard to protect patient well-being.

In conclusion, BS EN ISO 594-4:2021 sets the guidelines for conical fittings used in medical devices, ensuring compatibility, reliability, and safety. By following this standard, healthcare providers can reduce the risk of misconnections, prevent leaks or contamination, and ultimately enhance patient care in various medical settings.