ISO 10555-1:2023— Intravascular Catheters

Nurse preparing medication for bloodstream infection in a hospital with an intravascular catheter, which adheres to ISO 10555-1:2023.

Intravascular catheters are an indispensable tool in modern-day medical practice, both for patients with acute injuries and for those with chronic illnesses. Approximately 90% of patients admitted to hospital require some form of short- or long-term IV catheter therapy to deliver medications, nutritional supplements, and blood products directly into the bloodstream using a peripheral or central venous catheter. ISO 10555-1:2023— Intravascular Catheters – Sterile And Single-Use Catheters – Part 1: General Requirements provides specifications for intravascular catheters.

What Is an Intravascular Catheter Used for?

Intravascular lines and devices are used increasingly for the administration of fluids, medication, blood products, and nutrition for hemodynamic monitoring and hemodialysis. They are also used to continuously sample and monitor a patient’s blood pressure and blood gases and are often employed during surgical procedures when a patient is under anesthesia. Central venous catheters, as well as some other long-term IV devices, have integrated cuffs which anchor them in place to reduce mechanical damage at the insertion point. More sophisticated vascular catheters also include multi-lumen devices (e.g., Hickman line), which allow both drug administration and blood sampling.

What Is ISO 10555-1?

ISO 10555-1:2023 specifies general requirements for intravascular catheters, supplied sterile and intended for single use, for any application. It defines an intravascular catheter as a “tubular device, single or multilumen, designed to be partially or totally inserted or implanted into the vascular system for diagnostic and/or therapeutic purposes.”

The standard details requirements for risk approach; usability engineering; sterilization; shelf life; detectability; biocompatibility surface; corrosion resistance; peak tensile force; freedom from leakage during pressurization; freedom from leakage during aspiration; hubs; flowrate; power injection burst pressure; packaging system; simulated use, kink and/or torque testing to consider depending on device design, intended use, and risk analysis; coating integrity and/or particulate testing to consider depending on device design, intended use, and risk analysis; and distal tip stiffness testing to consider for neurovascular applications. It also details specifications for the designation of nominal size of the catheter.

ISO 10555-1:2023 does not apply to intravascular catheter accessories, e.g., those covered by ISO 11070.

Although intravascular catheters and devices provide necessary vascular access, their use puts patients at risk for local and systemic infectious complications, including local site infection, Catheter-related bloodstream infection (CRBSI), septic thrombophlebitis, endocarditis, and other metastatic infections (e.g., lung abscess, brain abscess, osteomyelitis, and endophthalmitis). The rate of all catheter-related infections (including local infections and systemic infections) is difficult to determine. CRBSI is an ideal parameter since it represents the most serious form of catheter-related infection; however, the rate of such infection depends on how CRBSI is defined. Consequently, health-care professionals should recognize the difference between surveillance definitions and clinical definitions. 

Moreover, prevention of these infections requires careful attention to optimal catheter selection, insertion, and maintenance, and removal of catheters when they are no longer needed. Here are some indicators from the Center of Disease Control and Prevention (CDC) to help prevent intravascular catheter-related bloodstream infection:

  1. Quality Assurance and Continuing Education: Health-care providers provide, monitor, and evaluate care and to become educated are critical to the success of this effort (e.g., specialized “IV teams” have shown unequivocal effectiveness in reducing the incidence of catheter-related infections and associated complications and costs).
  2. Site of Catheter Insertion:  The site at which a catheter is placed influences the subsequent risk for catheter-related infection and phlebitis. The influence of site on the risk for catheter infections is related in part to the risk for thrombophlebitis and density of local skin flora, a major risk factor for CRBSI.
  3. Type of Catheter Material: Teflonor polyurethane catheters have been associated with fewer infectious complications than catheters made of polyvinyl chloride or polyethylene. Steel needles used as an alternative to catheters for peripheral venous access have the same rate of infectious complications as do Tefloncatheters.
  4. Hand Hygiene and Aseptic Technique: For short peripheral catheters, good hand hygiene before catheter insertion or maintenance, combined with proper aseptic technique during catheter manipulation, provides protection against infection.

Information to be Supplied with the Catheter

ISO 10555-1:2023 details that the catheter should be accompanied by information, including instruction for use, that is sufficient for its safe use, considering the training and knowledge of intended users and the intended use environment. Any markings needed for the safe use of the catheter should be visible and legible. Further, all dimensions given should be expressed in SI units of measurement. Units of measurement systems other than those specified should additionally be given if clinically relevant. For neurovascular devices, additional units of measurement should be given as specified:

  • For outside diameter: inches, and French
  • For inside diameter: inches
  • For sheath inside diameter: inches, and French.

If required, this information should be assessed by the manufacturer based on the risk assessment.

Where appropriate, specific information to be supplied by the manufacturer should be selected from ISO 20417, and symbols should be selected from ISO 15223-1.

ISO 10555-1:2023— Intravascular Catheters – Sterile And Single-Use Catheters – Part 1: General Requirements is available on the ANSI Webstore.

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