What are the implications for manufacturers transitioning from ISO 594 to ISO 80369-7?
Design and Development
Stricter Dimensional Requirements: Manufacturers must redesign their luer connectors to meet the more precise dimensional specifications outlined in ISO 80369-7. This includes adhering to the new 't' dimension, which measures from the end of the male luer tip to the first fully formed thread. The previous ISO 594 allowed for more variability in dimensions, as long as the connector could function properly.
Unified Material and Dimension Requirements: ISO 80369-7 combines the separate dimensional requirements for semi-rigid and rigid materials into one set, requiring full compliance with both material and dimensional specifications. This means that manufacturers can no longer rely on meeting only the performance requirements while having less precise dimensions.
Material Selection
Higher Elastic Modulus Requirement: The new standard mandates that the material used for luer connectors must have an elastic modulus greater than 700 MPa when tested in tension or flexure. This requirement eliminates the use of some softer polymers that were previously acceptable under ISO 594, such as certain types of polyethylene.
Testing and Validation
Comprehensive Testing Against Reference Connectors: Manufacturers must now test their luer connectors against both luer slip and luer lock reference connectors, ensuring compliance with both types of connections. This was not as strictly required under ISO 594.
Modified Assembly and Test Procedures: The testing procedures have been updated to align with modern testing equipment and methods. This includes modifications to assembly tests and the addition of guidance for performing variable tests.
Non-Interconnectability Testing: ISO 80369-7 emphasizes the importance of preventing misconnections, requiring manufacturers to demonstrate that their connectors cannot be easily connected to incompatible devices.
Production and Quality Control
Enhanced Quality Control Measures: Manufacturers need to implement stricter quality control processes to ensure that each connector meets the new dimensional and material requirements. This may involve investing in new equipment or updating existing production lines.
In-Process Checks: The shift from ISO 594 to ISO 80369-7 requires manufacturers to adapt their in-process checks. For example, the go/no-go gauging test used in ISO 594 is no longer applicable, and alternative methods must be employed to monitor process consistency.
Regulatory Compliance and Market Access
Regulatory Deadlines and Submissions: Manufacturers must ensure that their products comply with ISO 80369-7 before regulatory deadlines, such as the FDA's requirement for new product submissions to meet ISO 80369 standards. Failure to comply can result in delays in product approval and market entry.
Market Differentiation: By adopting ISO 80369-7, manufacturers can differentiate their products in the market as compliant with the latest safety standards, potentially gaining a competitive advantage.