What is EN ISO 80369-20:2021 ?

EN ISO 80369-20:2021 and EN ISO 2226:2020 are two important technical standards that have a significant impact on the safety and efficiency of medical devices.

EN ISO 80369-20:2021 is a technical standard that sets the requirements for small-bore connectors specifically intended for use in enteral applications. These connectors must be designed to prevent any misconnections, which can lead to serious consequences such as medication errors, infections, or even death. EN ISO 80369-20:2021 aims to reduce the risk of misconnection by ensuring that connectors for enteral applications are incompatible with other types of medical tubing or devices.

On the other hand, EN ISO 2226:2020 is an international standard developed by the European Committee for Standardization (CEN) and the International Organization for Standardization (ISO) to provide guidelines and requirements for documenting human factor achievements in manufacturing systems design. This standard emphasizes the importance of human-centered design and aims to create a harmonized approach to maximize human performance and minimize errors.

In conclusion, EN ISO 80369-20:2021 and EN ISO 2226:2020 are two important technical standards that have a significant impact on the safety and efficiency of medical devices. By implementing these standards, healthcare professionals can be confident that they are using connectors that are specifically designed for their intended use, minimizing the risk of harm to patients.