FDA Updates List of Recognized Standards

The agency has said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.

The U.S. Food and Drug Administration has added two standards on small connectors for liquids and gases in healthcare applications to its list of recognized standards. The standards — AAMI/CN3:2014 (PS) and AAMI/CN20:2014 (PS) — establish requirements for connectors for enteral applications and common test methods.

In a Federal Register notice dated February 11, the agency said the new standards are meant to reduce the risk of unintended connections between enteral and non-enteral devices.

A small-bore connector is used to link or join medical devices, components and accessories for the purpose of delivering fluids or gases. Enteral applications are administered via the intestine.

Both the updated list and the FDA’s Guidance on the Recognition and Use of Consensus Standards are available on the agency’s website.

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