ISO 10555-1 specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. ISO 10555-1 does not apply to intravascular catheter accessories. The text of ISO 10555-1:2023 has been approved in Europe as EN ISO 10555-1:2023 without any changes.
Some of the changes in the standard are:
— added clarification on requirements and added new ones (Clause 4),
— added text on “Nominal inside diameter for some applications” (Clause 5),
— added test details in the instructions for use for power injection (Clause 6),
— clarified Annex B and Annex D,
— introduced alternative test method using a constant flowrate source (Annex G),
— added new Annex I for alternative leakage under pressurization using air pressure and added new Annex J for rationale.
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