What is BS EN ISO 80369-7:2017?

BS EN ISO 80369-7:2017 is an international standard that defines the requirements for small-bore connectors used in healthcare applications. It was developed by the International Organization for Standardization (ISO) and is intended to improve patient safety by ensuring compatibility between medical devices and their associated tubing connectors.

Why is it important?

The standard addresses the issue of misconnections in healthcare settings, which can have serious consequences for patient safety. In the past, there have been instances where medical devices with different functionalities were mistakenly connected, resulting in medication errors, infections, and even deaths. BS EN ISO 80369-7 aims to prevent these incidents by providing a clear framework for the design and testing of small-bore connectors.

Key features and requirements

The standard specifies several key features and requirements for small-bore connectors. Firstly, it defines the dimensions and tolerances for the connectors to ensure proper fit and prevent accidental disconnections. Secondly, it establishes requirements for the materials used in the construction of the connectors, including chemical compatibility, durability, and sterility. Thirdly, it outlines testing procedures to assess the connectors' performance under various conditions, such as pressure, temperature, and impact.

Furthermore, BS EN ISO 80369-7 addresses labeling and packaging requirements to provide clear identification and traceability of connectors. It also includes guidelines for manufacturers on documentation, quality management systems, and post-market surveillance. Compliance with this standard ensures that medical devices are designed and manufactured with patient safety in mind.

Implications and implementation challenges

The implementation of BS EN ISO 80369-7 poses some challenges for healthcare providers and manufacturers. Firstly, it requires the phasing out of existing connectors that do not meet the standard's requirements. This transition may involve replacing a significant number of medical devices and retraining healthcare professionals on the use of new connectors. Manufacturers also need to invest in redesigning their products and obtaining certification to comply with the standard.

Additionally, harmonization between different regions and countries is crucial to ensure global adoption of the standard. Since medical devices are often manufactured and sold internationally, a unified approach to small-bore connectors is necessary to avoid confusion and potential misconnections. Collaboration between regulatory bodies, industry stakeholders, and healthcare professionals is essential to facilitate the implementation process.