ISO 11607 Standards
Life Science Outsourcing has deep expertise in providing packaging testing that complies with all relevant International ISO-11607 standards and requirements.
ISO 11607 Standards Expertise
The process of developing and constructing a packaging system for terminally sterilized medical devices is a convoluted and pressing endeavor. The definitive nature of the medical device, the intended sterilization methods, the intended use, expiration date, transport, and storage all influence the packaging system design and choice of materials. The combination of the medical device and the packaging system should perform efficiently, safely, and adequately in the end-user’s hands.
ISO 11607-1
ISO 11607-1 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods.
Goals of a Terminally Sterilized Medical Device Packaging System:
Packaging System Performance Testing / Distribution Simulation
- ISTA Procedures 1, 2, 3
- ASTM-D4169
Stability Testing / Shelf Life Study
- Accelerated Aging (ASTM-F1980)
- Real-time Aging (A requirement to backup an accelerated aging study)
Packaging System Integrity Testing
- Package Integrity (ASTM-F2096: Bubble Test)
- Seal Integrity (ASTM-F1886: Visual Inspection, ASTM 1929: Dye Test)
- Seal Strength (ASTM-F88: Peel Test , ASTM-F1140: Burst Test)
Testing Requirements
Testing includes, but is not limited to:
- ASTM-F1886
Visual Inspection Test - ASTM-F88
Peel Strength Test - ASTM-F1140
Burst Test - ASTM-F1929
Dye Penetration Test - ASTM-F1140
Creep Test - ASTM-F2096
Bubble Emission Test
