BS ISO 11040-6:2019

Comprehensive Standard for Prefilled Syringes

BS ISO 11040-6:2019 is the essential standard for the design, development, and production of prefilled syringes. This comprehensive standard, developed by the International Organization for Standardization (ISO), provides detailed requirements and guidance to ensure the safety, quality, and performance of prefilled syringes used in the healthcare industry.

Ensuring Patient Safety and Product Reliability

Prefilled syringes are a critical component of modern healthcare, offering numerous benefits in terms of convenience, accuracy, and safety for both patients and healthcare professionals. BS ISO 11040-6:2019 sets the benchmark for prefilled syringe design, materials, and performance, helping manufacturers deliver products that meet the highest standards of quality and reliability.

• Detailed requirements for syringe design, including dimensions, tolerances, and compatibility with other medical devices
• Strict guidelines for the selection and testing of materials, ensuring biocompatibility and chemical compatibility
• Comprehensive performance testing procedures, covering parameters such as breakloose and glide forces, container closure integrity, and sterility
• Guidance on the development and validation of manufacturing processes to ensure consistent, high-quality production

Compliance and Regulatory Alignment

Compliance with BS ISO 11040-6:2019 is essential for medical device manufacturers seeking to market their prefilled syringes in the global healthcare market. This standard is harmonized with the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), ensuring that products meeting its requirements will also satisfy the relevant regulatory requirements.

• Alignment with the latest regulatory frameworks, including the EU MDR and IVDR, to streamline the approval process
• Comprehensive coverage of design, materials, and performance requirements to support regulatory submissions
• Recognized as a benchmark for quality and safety in the global healthcare industry

Optimizing Product Performance and Patient Outcomes

By adhering to the rigorous requirements of BS ISO 11040-6:2019, medical device manufacturers can develop prefilled syringes that deliver superior performance and reliability, ultimately improving patient outcomes and healthcare delivery.

• Improved dose accuracy and consistency, ensuring patients receive the correct medication dosage
• Enhanced user experience and ease of use for healthcare professionals, reducing the risk of administration errors
• Increased product stability and shelf life, minimizing waste and ensuring the availability of critical medications
• Reduced risk of contamination and infection, safeguarding patient health and safety

BS ISO 11040-6:2019 is an essential standard for any medical device manufacturer producing prefilled syringes. By aligning their products with this comprehensive standard, companies can demonstrate their commitment to quality, safety, and regulatory compliance, ultimately positioning their prefilled syringes for success in the global healthcare market.