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.
EN ISO 10555-6:2017 history
2019EN ISO 10555-6:2017/A1:2019 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports - Amendment 1 (ISO 10555-6:2015/Amd 1:2019)
2017EN ISO 10555-6:2017 Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports