BS EN 868-9:2018

Comprehensive Packaging for Medical Devices

BS EN 868-9:2018 is the essential standard for packaging materials used in the healthcare industry. It specifies the requirements and test methods for porous materials intended to be used as packaging for terminally sterilized medical devices.

This British Standard ensures medical device packaging is designed to maintain sterility and protect the contents from damage during storage and transportation. Compliance with BS EN 868-9:2018 is crucial for medical device manufacturers, distributors, and healthcare providers to safeguard patient safety.

Key Benefits of BS EN 868-9:2018

Sterile Packaging

• Specifies materials and designs that prevent microbial contamination of sterile medical devices
• Ensures packaging maintains sterility throughout the supply chain
• Protects patients from risk of infection due to compromised packaging

Secure Packaging

• Defines performance requirements for packaging strength and durability
• Prevents damage to medical devices during handling, storage, and transportation
• Ensures the integrity of the packaging is maintained until the point of use

Regulatory Compliance

• Aligns with EU Medical Device Regulation (MDR) 2017/745 requirements
• Helps manufacturers demonstrate conformity with essential safety and performance criteria
• Supports regulatory approval and market access for medical devices

Comprehensive Packaging Specifications

BS EN 868-9:2018 covers a wide range of technical requirements for porous packaging materials used with terminally sterilized medical devices, including:

• Material composition and properties
• Dimensional requirements and tolerances
• Strength and durability testing
• Microbial barrier performance
• Sterilization compatibility
• Labeling and marking

The standard also specifies the test methods to be used for evaluating the performance of packaging materials against these criteria.

Ensure Patient Safety with BS EN 868-9:2018

Compliance with BS EN 868-9:2018 is essential for medical device manufacturers, distributors, and healthcare providers to safeguard patient safety and meet regulatory requirements. By implementing the packaging standards defined in this British Standard, you can be confident that your medical devices are protected by secure, sterile packaging throughout the supply chain.

Purchase the official BS EN 868-9:2018 standard today to access the complete technical specifications and guidance needed to design, manufacture, and use compliant medical device packaging.