Burst strength
Bubble leak test
Dye penetration
Peel strength
Visual inspections
ISO 11607-1 (2006) – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 (2006) – Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F88: 1997 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1140: 2013 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
BS EN 868-5:2009 Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods.
