Aiming to improve the safety of medical device connections in clinical settings, ISO has published a new standard on neuraxial applications for small bore-connectors.
ISO 80369-6: Connectors for neuraxial applications specifies the requirements for connectors used in procedures such as anesthesia delivery and monitoring and removing cerebrospinal fluid.
Use of the standard will reduce the risk of the wrong product being administered, says Scott Colburn, convenor of the joint working group developing these standards and director of the CDRH Standards Program.
A small-bore connector is used to link or join medical devices, components and accessories for the purpose of delivering fluids or gases.
Historically, one type of connector was used for many different applications. However, following a series of accidents in the 1990s, the medical community recommended that different connectors be used for different applications to reduce risks. The FDA subsequently endorsed the recommendation.
Other upcoming ISO standards in the series include: Part 2: Connectors for breathing systems and driving gases applications, Part 3: Connectors for enteral applications and Part 7: Connectors for intravascular or hypodermic applications.
The other ISO standards in the series that are already published include Part 1, General requirements, which specifies the requirements for the designs and dimensions of small-bore connectors and Part 20, Common test methods, which supports the performance requirements.