BS EN ISO 10555-5:2013

## BS EN ISO 10555-5:2013: Sterile Intravascular Catheters StandardThis British Standard, BS EN ISO 10555-5:2013, specifies the requirements for sterile, single-use intravascular catheters. It is an identical adoption of the International Standard ISO 10555-5:2013, providing a comprehensive set of guidelines and technical specifications to ensure the safety, quality, and compliance of intravascular catheters used in healthcare settings.### Key Features and Benefits:- Ensures sterility and infection control: Detailed requirements for sterilization methods, packaging, and maintenance of sterility to minimize the risk of healthcare-associated infections.- Enhances patient safety: Specifies design, materials, and performance criteria to prevent complications such as thrombosis, embolism, and tissue damage.- Supports regulatory compliance: Aligns with the essential requirements of the EU Medical Devices Directive, enabling healthcare providers to demonstrate conformity with relevant regulations.- Promotes quality and consistency: Establishes standardized testing procedures and acceptance criteria for key characteristics, including dimensions, strength, and biocompatibility.- Facilitates international trade: Harmonizes with the ISO 10555 series, enabling the global exchange of intravascular catheters that meet consistent quality and safety benchmarks.### Technical Specifications:The standard covers the following key aspects of intravascular catheters:#### Design and Materials- Catheter types and configurations (e.g., single-lumen, multi-lumen, peripheral, central)- Allowable materials (e.g., polymers, metals, coatings) and biocompatibility requirements- Dimensional specifications (e.g., length, diameter, wall thickness)- Radiopacity and visibility features#### Sterility and Packaging- Sterilization methods (e.g., ethylene oxide, gamma irradiation)- Packaging design and integrity testing- Shelf-life and expiration dating#### Performance Requirements- Tensile strength, flexibility, and kink resistance- Flow rate and pressure resistance- Resistance to leakage and disconnection- Compatibility with accessories (e.g., connectors, stopcocks)#### Testing and Verification- Sample size and statistical methods for conformity assessment- Test methods for physical, chemical, and biological properties- Acceptance criteria for each performance characteristicBy adhering to the comprehensive requirements outlined in BS EN ISO 10555-5:2013, healthcare providers can ensure the safety and efficacy of intravascular catheters, while also demonstrating compliance with the relevant regulatory frameworks. This standard is an essential reference for manufacturers, distributors, and users of sterile, single-use intravascular catheters in the medical industry.