Compliance Framework for Small Bore Connectors (Luers) towards ISO 80369 standard | HCLTech

The chronological progression to adopt and recognize ISO 80369 series of standards from its antecedent ISO 594 series is now gradually transitioning into its implementation phase. The new series of standards are intended to have unique connector designs for each medical device application globally that are dimensionally driven and eliminates misconnection to unrelated healthcare applications.

The medical device manufacturers across the globe are proactively involved in analyzing their products impact towards the new ISO 80369 standard. The connector manufacturers are meticulously focusing to accept the changes of ubiquitous new standard and started to develop plans for shifting in order to ensure patient safety and uphold global markets. This whitepaper brings down the step by step processes involved towards regulatory conformity of a small bore connector for the new series of ISO 80369 standard based on authors perception and understanding in the field.

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