BS EN ISO 10555-3:2013

Comprehensive Standard for Sterile, Single-Use Intravascular Catheters

BS EN ISO 10555-3:2013 is a critical standard that establishes the requirements and test methods for sterile, single-use intravascular catheters. This standard is essential for healthcare providers, medical device manufacturers, and regulatory bodies to ensure the safety, quality, and compliance of these essential medical devices.

Ensuring Patient Safety and Infection Control

Intravascular catheters are widely used in healthcare settings for a variety of medical procedures, from intravenous (IV) therapy to diagnostic imaging. However, the risk of infection associated with these devices is a significant concern. BS EN ISO 10555-3:2013 addresses this issue by:

• Specifying the requirements for the sterility of single-use intravascular catheters, ensuring they are free from microbial contamination and pose a minimal risk of infection to patients.
• Defining the test methods and acceptance criteria for evaluating the sterility of these devices, providing a standardized approach to quality control and assurance.
• Outlining the packaging and labeling requirements to maintain the sterility of intravascular catheters during storage, transportation, and handling.

Improving Healthcare Outcomes and Compliance

In addition to patient safety, BS EN ISO 10555-3:2013 also addresses other critical aspects of intravascular catheter design and performance, including:

• Biocompatibility requirements to ensure the materials used in the catheter do not cause adverse reactions or toxicity in patients.
• Mechanical and physical properties, such as tensile strength, flexibility, and kink resistance, to ensure the catheter can be safely and effectively used for its intended purpose.
• Labeling and information requirements to provide healthcare professionals with the necessary details about the catheter, including its intended use, contraindications, and instructions for use.

Compliance and Regulatory Considerations

Compliance with BS EN ISO 10555-3:2013 is essential for medical device manufacturers and healthcare providers to meet regulatory requirements and ensure the safety and efficacy of intravascular catheters. This standard is harmonized with the essential requirements of the European Medical Devices Directive (MDD) and the new Medical Device Regulation (MDR), making it a critical reference for manufacturers seeking CE marking and market access in the European Union.

By adhering to the specifications and test methods outlined in BS EN ISO 10555-3:2013, medical device manufacturers can demonstrate the safety and performance of their intravascular catheters, while healthcare providers can be confident in the quality and reliability of the products they use to deliver patient care.