ISO 10555-6 Intravascular Catheters - Sterile and Disposable Catheters - Subcutaneous Implanted Ports

ISO 10555-6 specifies requirements, performance, and user safety considerations for 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 with non-core needles.

If the catheter is equipped with distance markings, the marking should be shown as follows:

• For untied catheters, specify the distance from the distal end of the catheter;
• For pre-tied catheters, specify the distance from the proximal end of the catheter.

From the first mark, the distance between the marks should not exceed 5 cm. Distance is recommended. markings should be 1 cm apart on the part of the catheter that is likely to be important to the user in positioning the catheter and monitoring catheter migration.

If provided, the following dimensions shall be expressed in millimetres:

• Subcutaneous implanted port dimensions;
• Effective surface area of ​​the septum, defined as the diameter or length and width of the septum at nominal size.

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