ISO 10555 Intravascular Catheters - Sterile and Single-Use Catheters

The “ISO 10555 Intravascular catheters - Sterile and single-use catheters” standard, developed by the International Organization for Standardization (ISO) , consists of the following sub-sections published under the same title:

• The standard "ISO 10555-1 Part 1: General requirements" describes the general requirements for intravascular catheters supplied in a sterile condition and intended for single-use. This standard does not apply to intravascular catheter accessories, such as those covered by ISO 11070.

The catheter must be sterilized by an appropriate validated method and comply with this standard in a sterile state. Parts of the catheter must be radiodetectable, if necessary, as determined by a risk assessment. Compliance must be demonstrated by an appropriate test method, such as ASTM F640-12 or DIN 132737. The catheter must be biohazard-free. ISO 10993-1 is applicable for the selection of appropriate test methods.

When examined with normal or corrected-to-normal vision, the external surface of the catheter's effective length should appear free of foreign matter at a magnification of at least 2,5x. The external surface of the catheter's effective length, including the distal tip, should be free of processing and surface defects that could cause trauma to vessels during use. If the catheter is lubricated, the lubricant should not be visible as liquid drops on the external surface.

When tested according to the method given in Appendix A, the metallic components of the catheter intended for fluid path contact shall show no signs of corrosion.

• The standard "ISO 10555-2 Part 2: Angiographic catheters" specifies the requirements for supplied and disposable angiographic catheters. However, this standard was later withdrawn and its content was added to ISO 10555-1.
• The “ISO 10555-3 Part 3: Central venous catheters” standard describes the requirements for central venous catheters supplied in sterile conditions and intended for single use.

For the purposes of this standard, a central venous catheter means a single- or multi-lumen intravascular catheter designed for the infusion or withdrawal of fluid into or from the central venous system or for pressure or other measurements. The catheter may have a fixation system that is part of the device.

Catheters must comply with ISO 10555-1 except for peak withdrawal force, to which the requirements of this standard apply.

If the catheter is equipped with distance markings, the marking system should indicate the distance from the distal end. From the first marking, the distance between the markings should not exceed 5 cm. It is recommended that the distance markings be 1 cm apart in the portion of the catheter likely to be important to the user in positioning the catheter and monitoring catheter migration.

With regard to lumen markings, in multi-lumen catheters, the identification of each lumen must be visible to the user.

For catheters with a tip made of a softer hardness material or a different construction from the shaft and a length not exceeding 20 mm, the minimum peak pullout force of the tip shall be as shown in the table when tested according to the method given in the appendix to ISO 10555-1 (Annex B). The minimum peak pullout force of all other parts of such catheters shall comply with ISO 10555-1.

The information provided by the manufacturer must comply with the ISO 10555-1 standard and also include:

• If the catheter is equipped with distance markings, a description of the marking system
• Flow rate per lumen
• Maximum guidewire diameter, if applicable
• A warning, if present, not to attempt to withdraw the catheter from the needle
• At least one recommended cleaning agent

Unless otherwise specified in this standard, balloon dilatation catheters must comply with the requirements of ISO 10555-1. Detection of balloon position: Balloon position should be determined by X-ray or other methods (ultrasound, MRI, etc.). Detection should be demonstrated by an appropriate test method, such as the test method specified in ASTM F640-20 or DIN 13273-7.

The nominal size of the catheter should be specified as follows:

• The diameter of the inflated balloon(s) expressed in millimeters (rounded to the nearest 0,1 mm or 0,01 mm) or, for multi-diameter balloons, the diameter of each section at nominal pressure
• Effective length of the balloon at nominal pressure
• The diameter of the largest guidewire that can be used with the catheter, if available
• Minimum internal diameter of the introducer, guide catheter, and sheath that can be used with the catheter (ISO 25539-2 standard is valid for stent delivery systems)

The balloon nominal burst pressure shall be determined when tested in accordance with Annex A. Longitudinal burst is the desired balloon burst mode, although other modes may be acceptable with appropriate justification.

• The standard “ISO 10555-5 Part 5: Over-the-needle peripheral catheters” describes the requirements for over-the-needle peripheral intravascular catheters designed for access to the peripheral vascular system, supplied sterile and for single use.

Unless otherwise specified in this standard, over-the-needle peripheral catheters should comply with ISO 10555-1. For multi-lumen catheters, the identity of each lumen should be clear to the user.

The catheter unit should be color-coded as indicated in the table to indicate the nominal outer diameter of the catheter tube. The distal end of the catheter unit should be tapered for ease of insertion and fit tightly onto the needle. When the needle is fully inserted into the catheter unit, the catheter tube should not extend beyond the heel of the needle bevel or be more than 1 mm from it.

If steel tubing is used, the needle must comply with ISO 9626. When examined with normal or corrected-to-normal vision at 2,5x magnification, the needle tip should appear sharp and free of feather edges, burrs, and hooks. The tip should be designed without a core. Appendix C shows examples of typical needle tip geometries.

The needle hub or other feature must allow for the detection of backlash and must be designed to communicate with the bore of the introducer needle tube. If the introducer needle is provided with a removable vent connection, the needle hub must comply with ISO 594-1. When the needle hub-to-needle tube mating strength is tested in accordance with Annex A, the needle tube must not become loose in the needle hub.

• ISO 10555-6 Part 6: Subcutaneous implanted ports" describes the requirements, performance, and user safety for subcutaneous implanted ports and catheters for long-term intravascular use, supplied under sterile conditions and intended for single use. This standard does not specify the requirements, performance, or user safety issues for coreless needles.

Unless otherwise specified in this standard, the port and catheter placed under the skin must comply with the ISO 10555-1 standard.

The subcutaneous implantable port must be free of biohazards. ISO 10993-1 is the standard for selecting appropriate test methods.

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

• For unconnected catheters, the distance from the distal end of the catheter should be specified
• For pre-connected catheters, the distance from the proximal end of the catheter should be stated.

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

Radiodetection must be in accordance with the ISO 10555-1 standard and the catheter must include the implant port and connection for subcutaneous placement.

The surface of the subcutaneous port should appear free of foreign matter when examined at a magnification of at least 2,5x with normal or corrected-to-normal vision.

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