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EVS-EN ISO 10555-1:2023

Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements (ISO 10555-1:2023)

General information
Valid from 15.12.2023
Base Documents
ISO 10555-1:2023; EN ISO 10555-1:2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.12.2023
Main
02.01.2018
Amendment
05.08.2013
Main
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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