BS ISO 11418-3:2016+A1:2017

# BS ISO 11418-3:2016+A1:2017: Sterile Urethral Catheters for Single Use## OverviewBS ISO 11418-3:2016+A1:2017 is the definitive standard for sterile urethral catheters designed for single-use applications in healthcare settings. This British Standard, identical to the international ISO 11418-3 standard, outlines the essential requirements and test methods for these critical medical devices.Ensuring the safety and efficacy of urethral catheters is paramount, as they are used to drain urine from the bladder in a wide range of medical procedures and treatments. This standard provides comprehensive technical specifications to verify that single-use catheters meet the highest quality and performance standards.## Key Technical Specifications- Materials and construction requirements for catheter components, including the tube, balloon, and connectors- Dimensional tolerances for critical parameters like catheter length, diameter, and balloon size- Sterilization methods and sterility assurance levels- Biocompatibility testing to ensure materials are safe for patient contact- Mechanical strength and integrity tests, including balloon inflation/deflation, leakage, and kinking resistance- Packaging and labeling requirements for single-use sterile catheters## Compliance BenefitsConformance to BS ISO 11418-3:2016+A1:2017 provides several important benefits for healthcare providers and medical device manufacturers:### Patient SafetyThe standard's rigorous technical requirements help ensure single-use urethral catheters are safe for patient use, minimizing the risk of infection, trauma, or other complications.### Quality AssuranceCompliance demonstrates a manufacturer's commitment to producing high-quality, reliable medical devices that meet international standards for performance and safety.### Regulatory AcceptanceAlignment with BS ISO 11418-3 facilitates regulatory approval and market access for single-use catheters in the UK, EU, and other jurisdictions recognizing this harmonized standard.### Competitive AdvantageCertification to this standard can give medical device companies a competitive edge by showcasing their products' adherence to the latest technical and quality requirements.## ConclusionBS ISO 11418-3:2016+A1:2017 is an essential standard for any organization involved in the manufacture, distribution, or use of single-use sterile urethral catheters. Conformance helps ensure these critical medical devices meet the stringent safety and performance criteria demanded by healthcare professionals and regulatory authorities worldwide.