BS EN ISO 10555-6:2017+A1:2019

Intravascular catheters. Sterile and single-use catheters. Subcutaneous implanted ports | Status: Current, Under review

1 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. This part of ISO 10555 does not specify requirements, performance, and user safety issues related to non-coring needles.

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.