BS EN 868-6:2017

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-6:2017 is the essential standard for healthcare professionals and manufacturers, providing comprehensive guidance on the packaging of terminally sterilized medical devices. This British Standard, identical to the European EN 868-6:2017, ensures that critical medical products are protected, preserved, and delivered safely to patients and healthcare facilities.

Ensuring Sterility and Compliance

Developed by experts in the field, BS EN 868-6:2017 outlines the specific requirements and test methods for packaging materials and systems used for the terminal sterilization of medical devices. By adhering to this standard, manufacturers can be confident that their packaging solutions:

• Maintain the sterility of the packaged medical device during storage and transportation
• Provide a reliable barrier against the ingress of microorganisms
• Comply with the essential requirements of the Medical Devices Directive (93/42/EEC)
• Meet the stringent quality and safety standards expected in the healthcare industry

Comprehensive Guidance for Packaging Design

This British Standard covers a wide range of packaging materials and systems, including:

• Porous materials (e.g., paper, nonwovens, and textiles)
• Plastic films and laminates
• Rigid plastic containers
• Packaging systems that combine different materials

For each type of packaging, BS EN 868-6:2017 provides detailed requirements and test methods to ensure the integrity and performance of the packaging throughout the entire product lifecycle, from sterilization to final use.

Optimizing Packaging Performance

By implementing the guidelines outlined in this standard, healthcare manufacturers and professionals can:

• Enhance the protection and preservation of sterile medical devices
• Minimize the risk of contamination and ensure patient safety
• Streamline the packaging and sterilization processes for improved efficiency
• Demonstrate compliance with relevant regulations and industry best practices
• Gain a competitive advantage by offering high-quality, reliable packaging solutions

Comprehensive Resource for the Healthcare Industry

BS EN 868-6:2017 is an essential reference for healthcare professionals, medical device manufacturers, and packaging suppliers. By adhering to this standard, organizations can ensure the integrity, safety, and compliance of their terminally sterilized medical products, ultimately contributing to better patient outcomes and a more robust healthcare system.