Test Methods

ISO Methods

• ISO 11607-1 (2009) - Packaging for Terminally Sterilized Medical Devices
• Part 1: Requirements for Materials, Sterile Barrier Systems, & Packaging Systems
• ISO 11607-2 (2006) - Packaging for Terminally Sterilized Medical Devices
• Part 2: Validation Requirements for Forming, Sealing, & Assembly Processes

ASTM Methods

• ASTM D4169-09 - Performance Testing of Shipping Containers & Systems
• ASTM D4332-01(06) - Conditioning Containers, Packages, or Packaging Components for Testing
• ASTM F88-09 - Seal Strength of Flexible Barrier Materials (Peel Test)
• ASTM F1929-12 - Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
• ASTM F2096-11 - Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
• ASTM F2054-07(12) - Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates
• ASTM F1140-07(12) - Internal Pressurization Failure Resistance of Unrestrained Packages
• ASTM F1886-09 - Determining Integrity of Seals for Medical Packaging by Visual Inspection

Visit us in Huntington Beach, California, for a one-on-one discussion about our proven methods for medical device package testing.