EN ISO 80369-3 Small Diameter connectors for Liquids and Gases in Healthcare Applications - Connectors for Enteral Applications

EN ISO 80369-3 specifies dimensions and requirements for the design and functional performance of small bore connectors intended for use for connections in enteral medical devices and accessories.

Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes and patient interface devices including access ports.

It does not specify dimensions or requirements for medical devices or accessories that use these connectors. Such requirements are specifically given in International Standards for certain medical devices or accessories.

Does not specify requirements for small diameter connectors used for:

• Medical devices aspirated only from the stomach;
• Oral medical devices only;
• Pressurizing and depressurizing the retention mechanism (eg, balloon) used to hold invasive enteral medical devices in place;
• Rectal drainage, medical devices for the rectal administration of drugs or fluids, and any other rectal access medical device;
• Gastrointestinal endoscopy equipment;
• Skin level gastrostomy medical devices.

Manufacturers are encouraged to include the small diameter connectors specified in EN ISO 80369-3 in enteral medical devices or accessories, even if not currently required by the relevant medical device standards. Requirements for small diameter connectors as specified in ISO 80369 are expected to be included when relevant specific medical device standards are revised.

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