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.
EUROLAB assists manufacturers with EN ISO 80369-7 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
