DDL is now able to provide testing for subcutaneous implanted ports in accordance with the newly added Part 6 of the ISO 10555 series of test standards. Part 6 standardizes the test methods for subcutaneous implanted ports. DDL’s capabilities include leakage, tensile and needle penetration as covered in Annex A, C, D and E of the standard.
The ISO 10555-6:2015 standard 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 addition to the ISO 10555 series helps catheter manufacturers better understand their products’ performance relative to criteria developed by industry experts. The additional guidance on subcutaneous implanted ports is welcomed as this a newly published part of the standard that fills the gap between FDA guidance and other industry recognized testing methods.