BS ISO 11040-2:2011

Comprehensive Standard for Prefilled Syringes

BS ISO 11040-2:2011 is the essential standard for the design, materials, and testing of prefilled syringes. This international standard, adopted by the British Standards Institution, provides comprehensive guidance to ensure the safety, quality, and compliance of this critical medical device.

Ensuring Patient Safety and Product Integrity

Prefilled syringes play a vital role in modern healthcare, delivering precise doses of essential medications. BS ISO 11040-2:2011 sets out rigorous requirements to safeguard patient wellbeing and maintain the integrity of the drug product. Key areas covered include: - Design Specifications: Detailed criteria for the syringe barrel, plunger, and other components to prevent leakage, breakage, or unintended activation. - Material Selection: Guidelines for choosing biocompatible, non-reactive materials that will not interact with or contaminate the drug formulation. - Functional Testing: Comprehensive test methods to verify critical performance attributes such as gliding force, air bubble formation, and sterility.

Ensuring Regulatory Compliance

Compliance with BS ISO 11040-2:2011 is essential for manufacturers of prefilled syringes to meet the stringent requirements of global healthcare regulators. This standard is harmonized with key directives and regulations, including: - Medical Devices Directive (MDD) 93/42/EEC - ISO 13485 Quality Management Systems - US FDA Quality System Regulation (21 CFR Part 820) By adhering to the specifications outlined in BS ISO 11040-2:2011, manufacturers can demonstrate that their prefilled syringes meet the highest standards of safety, quality, and regulatory compliance.

Key Benefits of Implementing BS ISO 11040-2:2011

- Safeguard Patient Safety: Rigorous design, material, and testing requirements to prevent product failures and drug contamination. - Ensure Regulatory Compliance: Harmonized with major global medical device regulations and quality standards. - Streamline Market Access: Demonstrate compliance to healthcare regulators and procurement authorities worldwide. - Enhance Brand Reputation: Differentiate your prefilled syringes as a high-quality, safety-focused medical device. - Optimize Manufacturing Processes: Comprehensive guidance to improve production efficiency and reduce waste.

Who Needs to Implement BS ISO 11040-2:2011?

This standard is essential for any organization involved in the manufacture, distribution, or use of prefilled syringes, including: - Pharmaceutical companies - Medical device manufacturers - Contract manufacturing organizations (CMOs) - Healthcare providers and facilities - Regulatory bodies and testing laboratories By implementing the requirements of BS ISO 11040-2:2011, these stakeholders can ensure the safety, quality, and compliance of this critical medical technology.