ISO 10555: An Overview

ISO 10555 is an international standard that outlines the general requirements for intravascular catheters. These are sterile devices intended for single use in medical applications, such as administering fluids, medications, or drawing blood. The standard ensures that these devices meet stringent safety and performance criteria, crucial for patient care.

ISO 10555 is divided into several parts, each addressing specific aspects of intravascular catheter requirements with Part 1 outlining the requirements for product testing:

Part 1: General Requirements - Outlines the essential characteristics all intravascular catheters must possess.

Part 2: Angiographic Catheters - Specifies requirements for catheters used in angiography.

Part 3: Central Venous Catheters - Focuses on catheters intended for central venous access.

Part 4: Balloon Dilatation Catheters - Covers catheters used for balloon angioplasty.

Part 5: Over-Needle Peripheral Catheters - Defines requirements for peripheral catheters inserted over a needle.

The Importance of ISO 10555 for Customers and Patients

Adherence to ISO 10555 is vital for the safety and effectiveness of intravascular catheters. The rigorous testing specified by the standard, while sometimes resulting in the destruction of products, is necessary to ensure that only high-quality, reliable devices reach patients. This testing process ensures:

• Patient Safety: Stringent testing protocols help prevent device failures that could lead to serious health risks, such as infections, thrombosis, or other complications.
• Product Reliability: Rigorous testing ensures that each catheter can reliably perform its intended function, which is critical in high-stakes medical procedures.
• Regulatory Approval: Meeting ISO 10555 standards is often a prerequisite for regulatory approval in many countries, enabling manufacturers to market their products globally.

Intravascular Catheters and ISO 10555

The ISO 10555 standard is specifically designed for intravascular catheters, which are inserted into the patient’s vascular system. These devices must comply with stringent requirements to ensure they function safely and effectively for their intended purposes, such as blood sampling, pressure monitoring, or intravenous fluid administration. Meeting these standards is crucial as it directly impacts patient safety and treatment efficacy.

Understanding the Changes to ISO 10555 for Product Leak Testing with ISO 10555-2023

With earlier iterations of ISO 10555, the leak testing process for intravascular catheters was conducted using water, as stipulated in ISO 10555:1-2013, Annex C. This method involves applying hydraulic pressure to the catheter and inspecting it for liquid leakage. While effective, this method can be destructive to the catheter components, leading to potential waste and less reliable manufacturing data.

With the latest version of ISO 10555, ISO 10555:1 – 2023, the requirement for leak testing the catheter has become easier with the addition of a non-destructive leak test method under Annex I. This new method involves immersing the catheter in a water bath and applying air pressure to detect any leakage in the form of air bubbles. With the addition of Annex I, the damage to the product is minimized and provides a more accurate and reliable method of determining if a leak is present. Although the catheter is required to be submerged in water per Annex I, this method provides a less destructive option for production and still ensures the product’s quality and integrity for patient safety.

Under the new Annex I method, the finished product (catheter) is connected to an instrument that can apply at minimum 300 kPa of air pressure and is then submerged into a water bath for 30 seconds. During the 30 second test time, any presence of bubbles forming in the water bath from the product indicates that the product has failed and does not pass the air leakage test requirement. With these new updates, you now have the option to perform a non-destructive leak test for ISO 10555 compliance with our leak instruments.

ISO 10555 Correlation for Production Environments with the Sprint mD

With the requirements for ISO 10555 compliance, the use of these methods in a manufacturing or production environment can be quite cumbersome as they usually result in less efficiency during the manufacturing process and inability to catch if a product is poorly manufactured while on the production line. With these issues, the correlation of a leak rate to these methods is paramount.

In a production environment, the need for non-traditional leak test methods to correlate a leak rate to the ISO 10555 testing requirements is becoming significantly important as production and quality managers work to achieve efficiency and product quality. During the development of a correlation method, a batch of known leak-free products are obtained and then controlled defects are introduced into them. These products are then tested with an air pressure leak instrument, Sprint mD, and with the ISO 10555 water bath test method simultaneously to determine the correlated leak rate for air to liquid. When developing this method, the first step of collecting leak free products is critical in ensuring that the correlation that is developed is accurate.

With the Sprint mD’s capabilities, an air to liquid correlated leak rate and program can be developed for use within the product manufacturing process. By providing real-time data without destroying the product, the Sprint mD enables you to maintain product quality standards and ensure efficiency on the production line.

Enhancing Intravascular Catheter Safety: ISO 10555 Innovations and Advanced Testing Technologies

ISO 10555 and its associated testing methods are critical for ensuring the safety and performance of intravascular catheters, and to guarantee that the final devices are safe and reliable for patient use. With the changes to ISO 10555, these requirements can be met more readily. In addition to that, integrating ISO 10555 standards with advanced pressure decay testing creates a framework for ensuring the integrity and safety of the finished product. With an air to liquid leak rate correlation to the ISO 10555 method, manufacturers can continue to achieve reliable and repeatable quality products without damaging the products during testing. This innovative approach enhances the efficiency and accuracy of the testing process, ultimately improving patient safety and product reliability. The adoption of advanced testing technologies with the Sprint mD represents a significant improvement in testing efficiency and product integrity.

For more information on ISO 10555 compliance or how to develop a correlation method to ISO 10555, please contact us below.

If you need immediate assistance with an application or project, or would like to learn more about the Sprint mD for ISO 10555 don’t hesitate to reach out to our team.  Click here to email us or call us at +1-281-671-2000. Let us know how we can help.