BS ISO 11040-4:2015+A1:2020 - Specification and Guidance for Pre-filled Syringes

The BS ISO 11040-4:2015+A1:2020 is a key standard that provides comprehensive guidelines for the design and use of pre-filled syringes within the healthcare sector. This document is crucial for manufacturers, healthcare professionals, and regulatory bodies as it aims to enhance the safety, effectiveness, and reliability of pre-filled syringe systems.

Purpose and Scope

The standard addresses the technical requirements related to pre-filled syringes, specifically focusing on the material compatibility, quality assurance, and performance evaluation of these devices. It serves as an essential reference for ensuring that pre-filled syringes meet the necessary criteria for medical efficacy and patient safety.

Key Features and Revisions

This revised version, including Amendment 1, encompasses existing provisions and introduces updated guidelines on how pre-filled syringes should be produced, maintained, and tested. It reflects industry advancements and evolving best practices, ensuring that stakeholders are equipped with current methodologies for syringe production.

• Material Compatibility: Details on the selection of materials that are suitable for use in fabricating pre-filled syringes, ensuring that they do not compromise the quality of the medication.
• Performance Testing: Guidelines on the necessary testing volumes, methods, and metrics to evaluate the syringe before market release.
• Manufacturing Processes: Insight into the latest manufacturing methodologies that conform to international standards, emphasizing quality control and safety measures.

Importance for Stakeholders

Manufacturers of pre-filled syringes will find this standard indispensable for meeting regulatory compliance and ensuring product safety. Healthcare practitioners benefit as well, acquiring enhanced knowledge on optimal syringe performance and patient handling techniques. Moreover, regulatory agencies can utilize this standard to establish consistent inspection and evaluation protocols, thus assuring the quality of medical devices available in the market.

Conclusion

In conclusion, the BS ISO 11040-4:2015+A1:2020 standard is a vital resource for anyone involved in the lifecycle of pre-filled syringes. Investing in this standard not only aligns stakeholders with international best practices but also promotes safer healthcare delivery through improved device reliability and patient safety.

Purchase Information

Available for £306.00, this standard is offered in both PDF and hard copy formats, making it versatile for various organizational needs. Acquire your copy today to ensure your practices remain compliant and cutting-edge in the evolving healthcare landscape.