BS EN ISO 10555-4:2013

# BS EN ISO 10555-4:2013: Sterile, Single-Use Intravascular Catheters## OverviewBS EN ISO 10555-4:2013 is the essential standard for the design, manufacture, and use of sterile, single-use intravascular catheters. This comprehensive standard, identical to ISO 10555-4:2013, provides detailed technical specifications and requirements to ensure the safety, quality, and compliance of these critical medical devices.Intravascular catheters are widely used in healthcare settings for a variety of procedures, from IV administration to diagnostic imaging. This standard is a vital reference for manufacturers, healthcare providers, and regulatory bodies, helping to maintain the highest levels of patient safety and clinical efficacy.## Key Technical Specifications- **Materials and Construction**: Outlines requirements for the materials, design, and construction of intravascular catheters, including biocompatibility, dimensional tolerances, and sterilization methods.- **Performance Requirements**: Specifies testing procedures and acceptance criteria for key performance characteristics, such as tensile strength, flexibility, kink resistance, and flow rate.- **Packaging and Labeling**: Provides guidelines for the packaging, labeling, and storage of sterile, single-use intravascular catheters to maintain product integrity and traceability.- **Sterilization**: Detailed requirements for the sterilization of intravascular catheters, including validation, monitoring, and documentation procedures.- **Biocompatibility**: Comprehensive testing and evaluation of the biological safety of materials and components used in intravascular catheter construction.## Compliance and BenefitsAdherence to BS EN ISO 10555-4:2013 offers a range of benefits for healthcare providers, manufacturers, and patients:### Improved Patient Safety- Ensures the use of high-quality, sterile intravascular catheters that meet rigorous safety standards- Minimizes the risk of infection, thrombosis, and other complications associated with catheter use### Regulatory Compliance- Aligns with the essential requirements of the EU Medical Device Regulation (MDR) and other relevant directives- Facilitates the CE marking process and market access for intravascular catheter products### Manufacturing Excellence- Provides a framework for the design, production, and quality control of intravascular catheters- Helps manufacturers optimize their processes and maintain consistent, reliable product quality### Increased Confidence- Demonstrates a commitment to patient safety and clinical best practices- Enhances the reputation and credibility of healthcare providers and medical device manufacturersBy implementing the specifications and requirements outlined in BS EN ISO 10555-4:2013, organizations can ensure the safety, quality, and compliance of their intravascular catheter products, ultimately contributing to improved patient outcomes and healthcare delivery.