BS EN ISO 10555-1:2013+A1:2017

Comprehensive Standard for Sterile Intravascular Catheters

The BS EN ISO 10555-1:2013+A1:2017 is the definitive standard for sterile intravascular catheters used in healthcare settings. This standard, developed by the International Organization for Standardization (ISO), provides detailed requirements and test methods to ensure the safety, quality, and compliance of these critical medical devices.

Ensuring Patient Safety and Infection Control

At the core of this standard is the imperative to protect patient health and prevent the risk of infection. The BS EN ISO 10555-1 standard covers the design, materials, and manufacturing processes for intravascular catheters, establishing stringent criteria to minimize the potential for contamination and adverse patient outcomes.Key requirements include:- Sterility and aseptic handling procedures- Biocompatibility of materials in contact with the body- Mechanical strength and resistance to damage or leakage- Compatibility with common disinfection and sterilization methodsBy adhering to these comprehensive specifications, healthcare providers can have confidence that the intravascular catheters they use meet the highest standards of safety and quality.

Comprehensive Testing and Validation

The BS EN ISO 10555-1 standard mandates a rigorous testing and validation process to verify the performance and safety of intravascular catheters. This includes:- Physical and dimensional testing- Evaluation of chemical and biological properties- Simulated-use testing to assess functionality and durability- Sterilization validation and package integrity testingThese thorough assessments ensure that intravascular catheters not only meet the design requirements but also maintain their integrity and effectiveness throughout their intended use.

Compliance and Regulatory Alignment

Compliance with the BS EN ISO 10555-1 standard is essential for healthcare organizations to demonstrate adherence to industry best practices and regulatory requirements. This standard is harmonized with the European Medical Device Regulation (MDR), providing a clear pathway for manufacturers to achieve CE marking and access the European market.Additionally, the standard's alignment with ISO 10993 for biocompatibility testing and ISO 11135 for ethylene oxide sterilization further reinforces its comprehensive approach to patient safety and regulatory compliance.

Elevating the Standard of Care

By implementing the BS EN ISO 10555-1:2013+A1:2017 standard, healthcare providers can elevate the standard of care for their patients and ensure the safe and effective use of intravascular catheters. This standard serves as a critical reference for manufacturers, healthcare professionals, and regulatory bodies, promoting the highest levels of quality, safety, and compliance in the medical device industry.