YY/T 0285.6-2020: Translated English of Chinese Standard. (YYT0285.6-2020): Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports
This Part of YY/T 0285 specifies the relevant performance and safety requirements for sterile and single-use subcutaneous implanted ports. This Part applies to the subcutaneous implanted ports intended for long-term or persistent intravascular use, consisting of a subcutaneously implanted infusion port and catheter.
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Annex A Normative Test method for no gas leakage
Normative Test method for no leakage after multiple punctures
Figure G 2 Bending test system
adjusted Annex F applicable applies appropriate bacterial endotoxin breaking chips completed conducting connected contain the following determined diameter distance effective surface area ethylene oxide exceed expressed extraction force Figure Figure G.1 flow rate flushing volume following information force GB/T given in Annex greater implanted port according indicated infusion Intravascular catheters leak leakage least length less liquid lumen manufacturer manufacturer's instructions mark maximum measure medical devices meet the requirements method given modifications nominal non-coring needle Normative NOTE number of punctures outlet tube patent peak Place ports and catheters power injection pressure priming volume Principle properties reach references report shall contain report The test requirements of YY residue seat septum single-use catheters space specified standards Steps Sterile and single-use subcutaneous implanted port suitable surgical implant temperature tensile test in accordance test instrument Test method test needle test report test solution tested according YY/T