BS EN 868-5:2018

Comprehensive Packaging Standard for Terminally Sterilized Medical Devices

BS EN 868-5:2018 is the essential standard for packaging materials used in the sterilization and distribution of terminally sterilized medical devices. This comprehensive standard outlines the specific requirements and test methods for porous materials, including paper, paperboard, nonwovens, and plastic films, to ensure the sterility, safety, and performance of packaged medical products.

Key Features and Benefits:

• Sterility Assurance: Provides detailed guidelines for the selection and testing of packaging materials to maintain the sterile barrier and prevent microbial ingress during storage and transportation.
• Regulatory Compliance: Ensures packaging solutions meet the essential requirements of the EU Medical Devices Regulation (MDR) and other relevant directives, enabling seamless market access.
• Durability and Integrity: Specifies performance criteria for packaging materials to withstand the rigors of terminal sterilization, handling, and distribution without compromising the sterile barrier.
• Traceability and Labeling: Outlines requirements for clear and comprehensive labeling, including sterilization method, expiry date, and other critical information.
• Sustainability: Promotes the use of environmentally friendly packaging materials and designs to minimize waste and support green initiatives.

Comprehensive Guidance for Packaging Professionals

BS EN 868-5:2018 is an indispensable resource for medical device manufacturers, packaging engineers, and quality professionals responsible for ensuring the sterility and safety of terminally sterilized products. The standard provides detailed technical specifications, test methods, and guidance on the selection, validation, and use of appropriate packaging materials and systems.

Key Technical Specifications:

• Requirements for porous materials, including paper, paperboard, nonwovens, and plastic films
• Test methods for evaluating properties such as tensile strength, bursting strength, and water vapor transmission rate
• Guidance on the selection and use of sterilization indicators and process challenge devices
• Labeling and traceability requirements, including the use of symbols and other markings
• Recommendations for packaging design, including seal strength, package integrity, and compatibility with sterilization processes

By adhering to the comprehensive requirements outlined in BS EN 868-5:2018, medical device manufacturers can ensure the sterility and safety of their products, while also streamlining regulatory compliance and supporting sustainable packaging initiatives. This standard is an essential tool for any organization involved in the packaging and distribution of terminally sterilized medical devices.