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

Stability Testing / Shelf Life Study

Packaging System Integrity Testing

Testing Requirements

Testing includes, but is not limited to:

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