ISO 10555-1 is part of the ISO 10555 series, which specifies requirements for intravascular catheters, devices commonly used in medical procedures to administer fluids, medications, or to measure pressures within the body’s vascular system. This specific part, ISO 10555-1:2013, titled “Intravascular catheters – Sterile and single-use catheters – Part 1: General requirements,” outlines the general requirements for the design, manufacture, and testing of sterile, single-use intravascular catheters.
ISO 10555-1 is linked to several other standards linked to medical device requirements:
- ISO 10993-1 related to biological safety of medical devices;
- ISO 11607-1, focused on packaging requirements for sterile medical devices;
- ISO 14971, focused on risk management process;
- ISO 15223-1, detailing the requirements for medical device labelling;
- ISO 80369, leur lock connectors requirements;
Importance of ISO 10555-1
ISO 10555-1 is crucial in the medical field as it ensures the safety, efficacy, and reliability of sterile, single-use intravascular catheters, which are essential for various medical procedures such as intravenous therapy, arterial catheterization, and central venous access. By setting rigorous design, manufacturing, and testing standards, ISO 10555-1 helps to minimize risks associated with catheter use, such as infections, thrombosis, and mechanical failures. It mandates biocompatibility of materials, validated sterilization processes, and comprehensive performance testing, ensuring that catheters are safe and effective for patient use. Additionally, this standard facilitates regulatory compliance, aiding manufacturers in meeting international requirements and accessing global markets.
In the next sections we will discuss specific requirements related to ISO 10555-1.
Requirements for peak tensile force
Each section of the catheter must undergo peak tensile force testing as outlined in Annex B of ISO 10555-1. There are minimum peak tensile force requirements for various sized tubular test pieces, which have defined within the ISO 10555-1. Testing can be performed on the entire device or on individual sections; however, each must meet the minimum peak tensile defined I the standard.
This document does not establish peak tensile force requirements for tubing with an outside diameter of less than 0.55 mm (prehydration outside diameter for hydratable intravascular catheters). In these instances, the tensile test should follow Annex B of ISO 10555-1, and the manufacturer must determine the peak tensile force based on a risk assessment.
For a distal tip with a junction to the shaft tube, the manufacturer must determine the peak tensile force based on a risk assessment. If the distal tip is less than 3 mm in length and has a junction where a tensile test is impractical, the manufacturer should define the test method and requirements based on a risk assessment. If the distal tip is less than 3 mm in length without a junction to the shaft tube, tensile testing is not required. For distal tips equal to or longer than 3 mm without a junction to the shaft tube, the manufacturer must determine the peak tensile force based on a risk assessment.
The forces encountered during clinical use may exceed the values listed in Table 1 of ISO 10555-1. For example, the forces applied to a delivery system during clinical use—such as accessing the intended location, deploying the device, or withdrawing the system—may be higher. If the manufacturer determines that the forces experienced during clinical use surpass the values in Table 1 of ISO 10555-1, the acceptance criteria for the peak tensile force of each test piece must be established by the manufacturer based on a risk assessment.
Simulated Use Testing, Kink and torque testing as per ISO 10555-1
Simulated use testing, kink testing, and torque strength testing should be considered, if applicable, for devices intended to traverse anatomy that might expose them to multiple modes of mechanical loading in sufficiently challenging clinical settings (e.g., guide catheters intended to reach neurovasculature or PTA balloons intended for use in a contralateral antegrade approach), based on a risk assessment. For simulated use testing, the device must perform as intended in a sufficiently challenging simulated clinical setting without sustaining damage that could impact its functionality or safety. For kink testing, the device must resist kinking when used in a sufficiently challenging radius of curvature. For torque testing, the device must resist damage that could affect its functionality or safety when subjected to sufficiently challenging torque. Clinical use conditions or scientific justification should be used to establish methods and criteria, depending on the device design, intended use, and risk analysis.
Other Requirements
The ISO 10555-1 specific a broad range of other requirements associated to medical device catheter design and development, including verification and validation activities. These requirements are the following:
- Risk Approach: Risk analysis, risk evaluation, risk control, and evaluation of residual risk acceptability must be conducted in accordance with ISO 14971.
- A usability engineering program must be developed and implemented in accordance with IEC 62366-1, addressing use risks and incorporating tests and/or assessments as part of design verification and validation.
- Parts of the catheter must be detectable by X-ray or other means (e.g., ultrasound, MRI, etc.) if required as determined by the risk assessment. Detectability should be demonstrated using an appropriate test method (see, e.g., ASTM F640-20 or DIN 13273-7).
- When examined with normal or corrected-to-normal vision and at a minimum magnification of 2.5x, the external surface of the catheter must appear free from foreign matter. The external surface of the catheter’s effective length, including the distal end, must be free from surface defects that could cause embolic risks or trauma to vessels. If the catheter is lubricated, the lubricant must not be visible as drops of fluid on the external surface when examined under normal or corrected-to-normal vision.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Regulatory matters within the medical device, information security and AI-Based business.
We offer a wide range of documentation kits to support your compliance efforts towards a wide range of standards and regulations, such as ISO 13485, EU MDR, ISO 27001, ISO 42001 and much more. . Specifically, in our webshop you will find:
- ISO 13485 Documentation / Compliance Kit
- ISO 27001 Documentation / Compliance Kit
- ISO 42001 Documentation / Compliance Kit
- FDA Cybersecurity Documentation
Within our sister platform QualityMedDev Academy, a wide range of online & self-paced training courses is available, such as for example:
- Complaint Handling and Vigilance Reporting
- Artificial Intelligence in Medical Device. Regulatory Requirements
- Unique Device Identification (UDI) Requirements according to EU MDR
- Clinical Evaluation Process According to EU MDR
- Medical Device SW Verification & Validation
- Risk Management for Medical Devices
- Usability Evaluation for Medical Devices
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
