BS ISO 11040-1:2015

Comprehensive Standard for Prefilled Syringes

BS ISO 11040-1:2015 is the essential standard for the design, development, and production of prefilled syringes. This comprehensive document provides detailed specifications and requirements to ensure the quality, safety, and performance of these critical medical devices.

Ensuring Quality and Compliance

As a healthcare professional or manufacturer, compliance with BS ISO 11040-1:2015 is crucial. This standard covers a wide range of technical specifications, including: - Design and Materials: Requirements for the syringe barrel, plunger, and other components to ensure compatibility, stability, and safety. - Functional Performance: Specifications for parameters like glide force, break-loose force, and air bubble formation to optimize usability and patient experience. - Sterilization and Packaging: Guidelines for sterilization methods and packaging to maintain sterility and product integrity. - Labeling and Traceability: Provisions for clear and comprehensive labeling, as well as unique device identification for traceability.

Enhancing Patient Safety and Outcomes

By adhering to the standards set forth in BS ISO 11040-1:2015, healthcare providers and manufacturers can ensure the highest levels of patient safety and positive clinical outcomes. Key benefits include: - Reduced Risk of Contamination: Strict requirements for sterility and packaging help prevent the introduction of harmful microorganisms, minimizing the risk of infection. - Improved Usability and Accuracy: Precise specifications for functional performance ensure that prefilled syringes are easy to use and deliver the intended dose accurately. - Enhanced Reliability: Comprehensive design and materials requirements contribute to the overall reliability and consistency of prefilled syringes, giving healthcare professionals confidence in the products they use. - Regulatory Compliance: Alignment with BS ISO 11040-1:2015 facilitates regulatory approval and market access, streamlining the commercialization process for manufacturers.

Comprehensive Guidance for Prefilled Syringes

BS ISO 11040-1:2015 is an essential resource for healthcare professionals, manufacturers, and regulators involved in the development, production, and use of prefilled syringes. By adhering to this standard, you can ensure the highest levels of quality, safety, and performance, ultimately contributing to better patient outcomes and a more efficient healthcare system.