BS EN ISO 7886-4:2019

Comprehensive Standard for Sterile Hypodermic Syringes

BS EN ISO 7886-4:2019 is the definitive standard for the design, performance, and testing of sterile hypodermic syringes used in healthcare applications. This British Standard, identical to ISO 7886-4:2018, provides detailed technical specifications and compliance requirements to ensure the safety, quality, and reliability of these critical medical devices.

Ensuring Patient Safety and Infection Control

Hypodermic syringes play a vital role in modern healthcare, facilitating the accurate and sterile administration of medications, vaccines, and other injectable solutions. This standard establishes stringent guidelines to mitigate the risks of contamination and ensure the highest levels of patient safety:

• Sterility requirements for the syringe and its components
• Specifications for the design, materials, and construction to prevent leakage or breakage
• Testing protocols for functional performance, including dose accuracy and plunger force
• Labeling and packaging requirements to maintain sterility and traceability

Compliance and Regulatory Alignment

BS EN ISO 7886-4:2019 aligns with the latest international standards and regulatory frameworks, ensuring that medical device manufacturers can demonstrate compliance and access global markets:

• Identical to ISO 7886-4:2018, the international standard for sterile hypodermic syringes
• Complies with the essential requirements of the EU Medical Devices Regulation (MDR 2017/745)
• Recognized by regulatory authorities worldwide, including the FDA and Health Canada
• Supports the implementation of quality management systems such as ISO 13485

Comprehensive Technical Specifications

This standard provides detailed technical requirements and test methods across a range of critical parameters, including:

• Design and Construction: Dimensions, materials, design features (e.g., luer connections, plungers, graduations)
• Functional Performance: Dose accuracy, plunger force, liquid leakage, air-tightness
• Sterilization and Packaging: Sterility assurance level, packaging integrity, shelf-life
• Labeling and Traceability: Identification, instructions for use, batch/serial numbers

By adhering to the comprehensive requirements of BS EN ISO 7886-4:2019, medical device manufacturers can demonstrate the safety, quality, and reliability of their sterile hypodermic syringes, meeting the stringent demands of the healthcare industry.