prEN ISO 10555-6

Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports

Scope

This part of ISO 10555 specifies requirements, performance and user safety issues related to subcutaneous implanted ports and catheters for intravascular long term use supplied in sterile condition and intended for single use.
NOTE: Subcutaneous implanted ports are known to be used for indications other than intravascular such as intra-peritoneal, intra-thecal, intra-pleural and epidural access.

Related legislation

Legislation related to this standard