This standard specifies dimensions and requirements for the design and functional performance of small bore connectors intended for use for intravascular connections or subcutaneous connections in subcutaneous applications of medical devices and accessories.
This standard does not specify requirements for medical devices or accessories that use these connectors. Such requirements are provided in specific documents for specific medical devices or accessories.
This standard does not specify requirements for the following small diameter connectors specified in other documents:
Manufacturers are encouraged to include the small diameter connectors specified in this standard in medical devices or accessories, even if they are not currently required by the relevant medical device documentation. Requirements for small diameter connectors as specified in EN ISO 80369 are expected to be included when the relevant specific medical device documentation is revised.
ISO 80369-1 specifies alternative methods of conformity with ISO 80369-1 for small diameter connectors intended for use with intravascular applications or hypodermic application medical devices or accessories that do not conform to this standard.
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