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EN 868-5 is the European standard that outlines the specific requirements for paper used in the manufacture of packaging materials for terminally sterilized medical devices. It is harmonized with EN ISO 11607 and addresses physical, microbiological, and chemical performance parameters of medical paper.
The standard defines acceptable ranges for:
- Microbial barrier properties
- Air permeability
- Tensile strength (machine & cross direction)
- Water repellency (Cobb value)
- Tear resistance and clean peelability
Hopeway AMD Sterilization Reels & Pouches are produced using certified 60gsm and 70gsm paper grades that comply with EN 868-5. All paper types are tested for:
- Compatibility with steam, FO and ETO sterilization
- Consistent bonding with PE/PET films
- Clear visual indicators of breach or mechanical damage
We also offer AMD Crepe Paper as an inner wrap or tray liner, which meets the requirements for lint-free and high-strength wrapping as outlined in EN 868-2 and EN 868-5.
Conforming Products:
- AMD Sterilization Reel & Pouch
- AMD One Step Nonwoven Wrap
- AMD Medical Crepe Paper
Through full compliance with EN 868-5, we support our clients in achieving safe, regulatory-compliant packaging for critical medical devices.
‘s-Gravenweg 542, 3065SG RotterdamThe Netherlands
+31 (0)10 254 28 08
