BS EN 868-3:2017

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-3:2017 is a critical standard that establishes the requirements and test methods for packaging materials used in the terminal sterilization of medical devices. This standard is an essential reference for manufacturers, healthcare providers, and regulatory bodies to ensure the safety, quality, and compliance of medical packaging solutions.

Ensuring Sterility and Integrity

The primary objective of BS EN 868-3:2017 is to safeguard the sterility and integrity of terminally sterilized medical devices throughout their entire lifecycle. The standard outlines rigorous testing procedures and performance requirements for packaging materials, including:

• Microbial barrier properties
• Strength and durability
• Seal quality and integrity
• Resistance to sterilization processes
• Compatibility with the packaged medical device

Comprehensive Technical Specifications

BS EN 868-3:2017 provides detailed technical specifications for a wide range of packaging materials, including:

• Porous materials (e.g., paper, nonwovens, and textiles)
• Plastic films and laminates
• Rigid plastic containers and trays
• Aluminum foils and laminates

The standard specifies the required physical, chemical, and microbiological properties for each material type, ensuring consistent performance and reliable sterility maintenance.

Compliance and Regulatory Alignment

Compliance with BS EN 868-3:2017 is essential for medical device manufacturers and healthcare providers to meet regulatory requirements and ensure the safety of their products. The standard is harmonized with the essential requirements of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), providing a clear path to demonstrating conformity.

Benefits of Implementing BS EN 868-3:2017

By adhering to the requirements of BS EN 868-3:2017, medical device manufacturers and healthcare providers can enjoy the following benefits:

• Increased patient safety and confidence through the use of reliable, sterile medical devices
• Reduced risk of healthcare-associated infections (HAIs) and other complications
• Streamlined regulatory compliance and easier market access for medical devices
• Improved supply chain efficiency and reduced waste through the use of high-quality, durable packaging materials
• Enhanced brand reputation and customer trust in the quality of medical products

BS EN 868-3:2017 is an essential standard for any organization involved in the manufacturing, distribution, or use of terminally sterilized medical devices. By implementing its requirements, you can ensure the safety, quality, and compliance of your medical packaging solutions, ultimately contributing to better patient outcomes and a more robust healthcare system.