BS ISO 11040-3:2012

Comprehensive Standard for Prefilled Syringes

BS ISO 11040-3:2012 is the essential standard for the design, materials, and testing of prefilled syringes. This comprehensive specification ensures the safety, quality, and compliance of this critical medical device, which is vital for the effective and reliable delivery of injectable drugs and medications.

Ensuring Safety and Reliability

Prefilled syringes play a crucial role in modern healthcare, providing a sterile, pre-measured dose of medication that can be quickly and easily administered. BS ISO 11040-3:2012 sets out rigorous requirements to guarantee the safety and reliability of these devices, covering:

• Design Specifications: Detailed guidelines for the syringe barrel, plunger, and other components to ensure consistent performance and prevent leakage or breakage.
• Material Requirements: Strict standards for the materials used in prefilled syringes, including glass, plastics, and elastomers, to ensure compatibility with the drug formulation and prevent contamination.
• Testing Procedures: Comprehensive testing protocols to verify the syringe's functionality, sterility, and compliance with all relevant safety and quality standards.

Ensuring Regulatory Compliance

Compliance with BS ISO 11040-3:2012 is essential for any manufacturer or supplier of prefilled syringes. This standard is harmonized with the European Medical Devices Directive (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), ensuring that products meeting its requirements will also satisfy the essential legal and regulatory requirements for the European market.

By adhering to the specifications outlined in BS ISO 11040-3:2012, manufacturers can demonstrate their commitment to quality, safety, and regulatory compliance, giving healthcare providers and patients the confidence they need to use these critical medical devices.

Key Benefits of BS ISO 11040-3:2012

• Ensures Safety and Reliability: Comprehensive design, material, and testing requirements to guarantee the performance and integrity of prefilled syringes.
• Supports Regulatory Compliance: Harmonized with the European MDD and IVDD, enabling manufacturers to demonstrate compliance with essential legal and regulatory requirements.
• Promotes Consistent Quality: Standardized specifications and testing procedures to ensure the consistent quality and performance of prefilled syringes across the industry.
• Enhances Patient Confidence: Rigorous standards and testing protocols that give healthcare providers and patients the assurance they need when using prefilled syringes.

By adhering to the requirements of BS ISO 11040-3:2012, manufacturers and suppliers can ensure the safety, quality, and compliance of their prefilled syringes, supporting the effective and reliable delivery of essential medications to patients worldwide.